0A4F4F9BD490A749D5437F821CF06DF1
42 CFR 11
https://www.govinfo.gov/content/pkg/CFR-2016-title42-vol1/pdf/CFR-2016-title42-vol1-part11.pdf
http://leaux.net/URLS/ConvertAPI Text Files/633B4909225723804ECBC63B57EDB2F1.en.txt
Examining the file media/Synopses/633B4909225723804ECBC63B57EDB2F1.html:
This file was generated: 2020-07-14 04:51:57
| Indicators in focus are typically shown highlighted in yellow; |
Peer Indicators (that share the same Vulnerability association) are shown highlighted in pink; |
"Outside" Indicators (those that do NOT share the same Vulnerability association) are shown highlighted in green; |
Trigger Words/Phrases are shown highlighted in gray. |
Link to Orphaned Trigger Words (Appendix (Indicator List, Indicator Peers, Trigger Words, Type/Vulnerability/Indicator Overlay)
Applicable Type / Vulnerability / Indicator Overlay for this Input
Political / criminal
Searching for indicator criminal:
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p.000131: party, and the principal investi- gator acknowledging the designation as responsible party to the
p.000131: Director in the format specified at https:// prsinfo.clinicaltrials.gov.
p.000131: (3) Withdra al of the designation of a principal investigator as the responsible party.
p.000131: In the event that a principal investi- gator who has been designated the re- sponsible party no longer
p.000131: meets or is no longer able to meet all the require- ments for being so designated under paragraph
p.000131: (c)(2)(i) of this section, the sponsor must withdraw the designation in the format specified at
p.000131: https:// prsinfo.clinicaltrials.gov, at which time the sponsor will be considered the re- sponsible party
p.000131: unless and until the sponsor makes a new designation in ac- cordance with paragraph (c)(2) of this section.
p.000131: § 11.6 What are the requirements for the submission of truthful informa- tion?
p.000131: The clinical trial information sub- mitted by a responsible party under this part shall not
p.000131: be false or mis- leading in any particular. A responsible party who submits false and/or mis- leading
p.000131: information is subject to civil monetary penalties and/or other civil or criminal remedies available
p.000131: under
p.000131: U.S. law.
p.000131: § 11.8 In what format must clinical trial information be submitted?
p.000131: Information submitted under this part must be submitted electronically to ClinicalTrials.gov, in the
p.000131: format specified at https:// prsinfo.clinicaltrials.gov.
p.000131: § 11.10 What definitions apply to this part?
p.000131: (a) The following definitions apply to terms used in this part:
p.000131: Adverse event means any untoward or unfavorable medical occurrence in a human subject, including any
p.000131: abnor-
p.000131: 42 CFR Ch. I (10–1–16 Edition)
p.000131: mal sign (for example, abnormal phys- ical exam or laboratory finding), symp- tom, or disease, temporally
p.000131: associated with the subject’s participation in the research, whether or not considered re- lated to the
p.000131: subject’s participation in the research. See also the definition of ‘‘serious adverse event.’’
p.000131: Applicable clinical trial means an ap- plicable device clinical trial or an ap- plicable drug clinical
p.000131: trial. Expanded access use under section 561 of the Fed- eral Food, Drug, and Cosmetic Act (21
p.000131: U.S.C. 360bbb) is not an applicable clin- ical trial.
p.000131: Applicable device clinical trial means:
p.000131: (1) A prospective clinical study of health outcomes comparing an inter- vention with a device product
p.000131: subject to section 510(k), 515, or 520(m) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
p.000131: 360(k), 21 U.S.C. 360e, 21
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p.000161: 42 CFR Ch. I (10–1–16 Edition)
p.000161: 402(j)(3)(C) and 402(j)(3)(I) of the Public Health Service Act (42 U.S.C. 282(j)(3)(C) and
p.000161: 42 U.S.C. 282(j)(3)(I)) or
p.000161: § 11.48, as applicable, and corrections have been made or addressed in re- sponse to any
p.000161: electronic notice re- ceived under § 11.64(b)(1). If no clinical trial results information is required to
p.000161: be submitted, a responsible party’s ob- ligation to correct or address errors ends on the date on
p.000161: which all required clinical trial registration information has been submitted as specified in sec- tion
p.000161: 402(j)(2)(A)(ii) of the Public Health Service Act (42 U.S.C. 282(j)(2)(A)(ii)) or
p.000161: § 11.28, as applicable, and corrections
p.000161: have been made or addressed in re- sponse to any electronic notice re- ceived under §
p.000161: 11.64(b)(1).
p.000161: (3) Compliance with the quality con- trol review process, including the re- quirements of this section,
p.000161: does not constitute a legal defense to enforce- ment pursuant to section 301(jj) of the Federal Food,
p.000161: Drug and Cosmetic Act (21 U.S.C. 331(jj)), section 303(f)(3) of the Federal Food, Drug and Cosmetic Act (21
p.000161: U.S.C. 333(f)(3)), or any other Fed- eral law.
p.000161:
p.000161: Subpart E—Potential Legal Con- sequences of Non-Compli- ance
p.000161: § 11.66 What are potential legal con- sequences of not complying with the requirements of this part?
p.000161: (a) Civil or criminal judicial actions. Failure to comply with the require- ments of this part,
p.000161: issued under section 402(j) of the Public Health Service Act (42 U.S.C. 282(j)), is a prohibited act
p.000161: under one or more provisions of section 301(jj) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 331(jj)):
p.000161: (1) Failure to submit the certifi-
p.000161: cation required by section 402(j)(5)(B) of the Public Health Service (42 U.S.C. 282(j)(5)(B)) that all
p.000161: applicable require- ments of section 402(j) have been met, or knowingly submitting a false cer- tification
p.000161: under section 402(j)(5)(B), is a prohibited act under section 301(jj)(1) of the Federal Food, Drug, and
p.000161: Cos- metic Act.
p.000161: (2) Failure to submit clinical trial in-
p.000161: formation required under section 402(j) of the Public Health Service Act is a prohibited act under
p.000161: section 301(jj)(2)
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p.000162:
p.000162:
p.000162:
p.000162:
p.000162:
p.000162:
p.000162:
p.000162: Public Health Service, HHS § 11.66
p.000162:
p.000162:
p.000162: of the Federal Food, Drug, and Cos- metic Act.
p.000162: (3) Submission of clinical trial infor- mation under section 402(j) that is false or misleading in any
p.000162: particular is a prohibited act under section 301(jj)(3) of the Federal Food, Drug, and Cos- metic
p.000162: Act.
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Political / political affiliation
Searching for indicator party:
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p.000130: 130
p.000130:
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p.000130:
p.000130:
p.000130:
p.000130:
p.000130: Public Health Service, HHS § 11.4
p.000130:
p.000130:
p.000130: 11.64 When must clinical trial information submitted to ClinicalTrials.gov be updated or corrected?
p.000130: Subpart E—Potential Legal Consequences of Non-Compliance
p.000130: 11.66 What are potential legal consequences of not complying with the requirements of this part?
p.000130: AUTHORITY: 42 U.S.C. 282(i); 42 U.S.C. 282(j);
p.000130: 5 U.S.C. 301; 42 U.S.C. 286(a); 42 U.S.C. 241(a);
p.000130: 42 U.S.C. 216(b).
p.000130: SOURCE: 81 FR 65138, Sept. 21, 2016, unless
p.000130: otherwise noted.
p.000130: EFFECTIVE DATE NOTE: At 81 FR 65138,
p.000130: Sept. 21, 2016, Part 11 was added, effective
p.000130: Jan. 18, 2017.
p.000130:
p.000130: Subpart A—General Provisions
p.000130: § 11.2 What is the purpose of this part?
p.000130: This part implements section 402(j) of the Public Health Service Act (42
p.000130: U.S.C. 282(j)) by providing require- ments and procedures for the submis- sion of clinical trial
p.000130: information for certain applicable clinical trials and other clinical trials to the Director of the
p.000130: National Institutes of Health (NIH) to be made publicly available via ClinicalTrials.gov, the
p.000130: Internet-acces- sible clinical trial registry and results data bank established by the National Library of
p.000130: Medicine (NLM) at https:// clinicaltrials.gov.
p.000130: § 11.4 To whom does this part apply?
p.000130: (a) This part applies to the respon- sible party for an applicable clinical trial that is required to
p.000130: be registered under § 11.22, a clinical trial for which clinical trial registration information or clinical
p.000130: trial results information is submitted voluntarily in accordance with § 11.60, or an applicable
p.000130: clinical trial that is required by the Director to have clinical trial information sub- mitted to protect
p.000130: the public health under § 11.62.
p.000130: (b) The responsible party must com-
p.000130: municate the identity and contact in- formation of the responsible party to the Director by submitting the
p.000130: Respon- sible Party, by Official Title and Re- sponsible Party Contact Information data elements under §
p.000130: 11.28(a)(2)(iii)(B) and (a)(2)(iv)(F) as part of the clinical trial information submitted at the time
p.000130: of registration. Changes must be
p.000130:
p.000130: communicated to the Director by up- dating information in accordance with
p.000130: § 11.64(a).
p.000130: (c) Determination of responsible party. For purposes of this part, each applica- ble clinical trial or other
p.000130: clinical trial must have one responsible party. With respect to a clinical trial, the sponsor of the
p.000130: clinical trial will be considered the responsible party unless and until a principal investigator has been
p.000130: des- ignated the responsible party, in ac- cordance with paragraph (c)(2) of this section. With
p.000130: respect to a pediatric postmarket surveillance of a device product that is not a clinical trial, the
p.000130: responsible party is the entity that the
p.000130: U.S. Food and Drug Adminstration (FDA), under section 522 of the Federal Food, Drug, and Cosmetic
p.000130: Act (21
p.000130: U.S.C. 3601), orders to conduct the pedi- atric postmarket surveillance of a de- vice product.
p.000130: (1) Determination of sponsor. For pur- poses of this part, each applicable clin- ical trial or other clinical
p.000130: trial must have one sponsor.
p.000130: (i) When an applicable clinical trial or other clinical trial is conducted under an investigational
p.000130: new drug ap- plication (IND) or investigational de- vice exemption (IDE), the IND or IDE holder will be
p.000130: considered the sponsor.
p.000130: (ii) When an applicable clinical trial or other clinical trial is not conducted under an IND or IDE, the
p.000130: single person or entity who initiates the trial, by preparing and/or planning the trial, and who
p.000130: has authority and control over the trial, will be considered the spon- sor.
p.000130: (2) Designation of a principal investi- gator as the responsible party.
p.000130: (i) The sponsor may designate a prin- cipal investigator as the responsible party if such principal
p.000130: investigator meets all of the following require- ments:
p.000130: (A) Is responsible for conducting the trial;
p.000130: (B) Has access to and control over the data from the trial;
p.000130: (C) Has the right to publish the re- sults of the trial; and
p.000130: (D) Has the ability to meet all of the requirements for submitting and up- dating clinical trial
p.000130: information as specified in this part.
p.000131: 131
p.000131:
p.000131:
p.000131:
p.000131:
p.000131:
p.000131:
p.000131:
p.000131:
p.000131: § 11.6
p.000131: (ii) With regard to an applicable clin- ical trial or other clinical trial, a des- ignation by the sponsor
p.000131: under para- graph (c)(2)(i) of this section shall con- sist of the sponsor obtaining from the principal
p.000131: investigator an acknowledg- ment of the principal investigator’s re- sponsibilities under this part as respon- sible
p.000131: party, and the principal investi- gator acknowledging the designation as responsible party to the
p.000131: Director in the format specified at https:// prsinfo.clinicaltrials.gov.
p.000131: (3) Withdra al of the designation of a principal investigator as the responsible party.
p.000131: In the event that a principal investi- gator who has been designated the re- sponsible party no longer
p.000131: meets or is no longer able to meet all the require- ments for being so designated under paragraph
p.000131: (c)(2)(i) of this section, the sponsor must withdraw the designation in the format specified at
p.000131: https:// prsinfo.clinicaltrials.gov, at which time the sponsor will be considered the re- sponsible party
p.000131: unless and until the sponsor makes a new designation in ac- cordance with paragraph (c)(2) of this section.
p.000131: § 11.6 What are the requirements for the submission of truthful informa- tion?
p.000131: The clinical trial information sub- mitted by a responsible party under this part shall not
p.000131: be false or mis- leading in any particular. A responsible party who submits false and/or mis- leading
p.000131: information is subject to civil monetary penalties and/or other civil or criminal remedies available
p.000131: under
p.000131: U.S. law.
p.000131: § 11.8 In what format must clinical trial information be submitted?
p.000131: Information submitted under this part must be submitted electronically to ClinicalTrials.gov, in the
p.000131: format specified at https:// prsinfo.clinicaltrials.gov.
p.000131: § 11.10 What definitions apply to this part?
p.000131: (a) The following definitions apply to terms used in this part:
p.000131: Adverse event means any untoward or unfavorable medical occurrence in a human subject, including any
p.000131: abnor-
p.000131: 42 CFR Ch. I (10–1–16 Edition)
p.000131: mal sign (for example, abnormal phys- ical exam or laboratory finding), symp- tom, or disease, temporally
p.000131: associated with the subject’s participation in the research, whether or not considered re- lated to the
p.000131: subject’s participation in the research. See also the definition of ‘‘serious adverse event.’’
p.000131: Applicable clinical trial means an ap- plicable device clinical trial or an ap- plicable drug clinical
p.000131: trial. Expanded access use under section 561 of the Fed- eral Food, Drug, and Cosmetic Act (21
p.000131: U.S.C. 360bbb) is not an applicable clin- ical trial.
p.000131: Applicable device clinical trial means:
p.000131: (1) A prospective clinical study of health outcomes comparing an inter- vention with a device product
...
p.000132: Cosmetic Act (21 U.S.C. 355) or a bio- logical product licensed for any use under section 351 of
p.000132: the Public Health Service Act (42 U.S.C. 262).
p.000132: Approved or cleared device means a de- vice product that is cleared for any use under section 510(k) of the
p.000132: Federal Food, Drug, and Cosmetic Act (21 U.S.C 360(k)) or approved for any use under sections 515 or 520(m)
p.000132: of the Federal Food, Drug, and Cosmetic Act (21 U.S.C 360e, 360j(m)).
p.000132: Arm means a pre-specified group or subgroup of human subject(s) in a clin- ical trial assigned to receive
p.000132: specific intervention(s) (or no intervention) ac- cording to a protocol.
p.000132: Clinical study means research accord- ing to a protocol involving one or more human subjects to evaluate biomedical
p.000132: or health-related outcomes, including interventional studies and observa- tional studies.
p.000132: Clinical trial means a clinical inves- tigation or a clinical study in which human subject(s) are
p.000132: prospectively as- signed, according to a protocol, to one or more interventions (or no interven- tion) to
p.000132: evaluate the effect(s) of the intervention(s) on biomedical or health-related outcomes.
p.000132: Clinical trial information means the data elements, including clinical trial registration information
p.000132: and clinical trial results information, that the re- sponsible party is required to submit to
p.000132: ClinicalTrials.gov, as specified in sec- tion 402(j) of the Public Health Service Act (42 U.S.C. 282(j)) and
p.000132: this part.
p.000132: Clinical trial registration information means the data elements that the re- sponsible party is required to
p.000132: submit to ClinicalTrials.gov, as specified in sec- tion 402(j)(2)(A)(ii) of the Public Health Service Act (42
p.000132: U.S.C. 282(j)(2)(A)(ii)) or
p.000132: § 11.28, as applicable.
p.000132: Clinical trial results information means the data elements that the responsible party is required
p.000132: to submit to ClinicalTrials.gov, as specified in sec- tions 402(j)(3)(C) and 402(j)(3)(I) of the
p.000132: Public Health Service Act (42 U.S.C. 282(j)(3)(C) and (I)) or § 11.48, as applica- ble. If a responsible
p.000132: party submits clin- ical trial results information volun- tarily for a clinical trial, clinical trial
p.000132:
p.000132: results information also means
p.000132: § 11.60(b)(2)(i)(B) or § 11.60(c)(2)(i)(B), as
p.000132: applicable.
p.000132: Comparison group means a grouping of human subjects in a clinical trial that is or may be used in analyzing
p.000132: the re- sults data collected during the clinical trial.
p.000132: Completion date means, for a clinical trial, including an applicable clinical trial, the date that the
p.000132: final subject was examined or received an interven- tion for the purposes of final collection of data for
p.000132: the primary outcome, whether the clinical trial concluded ac- cording to the pre-specified protocol or was
p.000132: terminated. In the case of clinical trials with more than one primary out- come measure with different comple-
p.000132: tion dates, this term refers to the date on which data collection is completed for all of the primary
p.000132: outcomes. For a pediatric postmarket surveillance of a device product that is not a clinical trial,
p.000132: completion date means the date on which the final report of the pedi- atric postmarket surveillance of
p.000132: the device product is submitted to FDA. For purposes of this part, completion date is referred to as
p.000132: ‘‘primary comple- tion date.’’
p.000132: Control or controlled means, with re-
p.000132: spect to a clinical trial, that data col- lected on human subjects in the clin- ical trial will be
p.000132: compared to concur- rently collected data or to non-concur- rently collected data (e.g., historical controls,
p.000132: including a human subject’s own baseline data), as reflected in the pre-specified primary or secondary out-
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p.000133: Pediatric postmarket surveillance of a device product means the active, sys- tematic, scientifically
p.000133: valid collection, analysis, and interpretation of data or other information conducted under sec- tion 522 of the
p.000133: Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360l) about a marketed device product that is ex-
p.000133: pected to have significant use in pa- tients who are 21 years of age or young- er at the time of diagnosis
p.000133: or treat- ment. A pediatric postmarket surveil- lance of a device product may be, but is not always, a clinical
p.000133: trial.
p.000133: Primary completion date means, for
p.000133: purposes of this part, ‘‘completion date.’’ See the definition of ‘‘comple- tion date.’’
p.000133: Primary outcome measure means the outcome measure(s) of greatest impor- tance specified in the protocol,
p.000133: usually the one(s) used in the power calcula- tion. Most clinical trials have one pri- mary outcome
p.000133: measure, but a clinical trial may have more than one. For pur- poses of this part, ‘‘primary outcome’’ has the
p.000133: same meaning as primary out- come measure.
p.000133: Principal investigator means the indi- vidual who is responsible for the over- all scientific and technical
p.000133: direction of the study.
p.000133: Protocol means the written descrip- tion of the clinical trial, including ob- jective(s), design, and
p.000133: methods. It may also include relevant scientific back- ground and statistical considerations.
p.000133: Responsible party means, with respect to a clinical trial, the sponsor of the clinical trial, as defined in
p.000133: 21 CFR 50.3; or the principal investigator of such clinical trial if so designated by a spon- sor, grantee,
p.000133: contractor, or awardee, so long as the principal investigator is re- sponsible for conducting the trial, has
p.000133: access to and control over the data from the clinical trial, has the right to publish the results of the
p.000133: trial, and has the ability to meet all of the require- ments under this part for the submis- sion of
p.000133: clinical trial information. For a pediatric postmarket surveillance of a device product that is not a
p.000133: clinical
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p.000134:
p.000134:
p.000134:
p.000134:
p.000134: Public Health Service, HHS § 11.10
p.000134:
p.000134:
p.000134: trial, the responsible party is the enti- ty who FDA orders to conduct the pedi- atric postmarket
p.000134: surveillance of the device product.
p.000134: Secondary outcome measure means an outcome measure that is of lesser im- portance than a primary
p.000134: outcome measure, but is part of a pre-specified analysis plan for evaluating the effects of the intervention
p.000134: or interventions under investigation in a clinical trial and is not specified as an exploratory or other
p.000134: measure. A clinical trial may have more than one secondary outcome measure. For purposes of this part,
p.000134: ‘‘secondary outcome’’ has the same meaning as secondary outcome meas- ure.
p.000134: Secretary means the Secretary of
p.000134: Health and Human Services or any other official(s) to whom the Secretary delegates the authority
p.000134: contained in section 402(j) of the Public Health Service Act (42 U.S.C. 282(j)).
p.000134: Serious adverse event means an ad- verse event that results in any of the following outcomes:
p.000134: Death, a life- threatening adverse event as defined in 21 CFR 312.32, inpatient hospitalization or prolongation
p.000134: of existing hospitaliza- tion, a persistent or significant inca- pacity or substantial disruption of the
p.000134: ability to conduct normal life func- tions, or a congenital anomaly/birth defect. Important medical
p.000134: events that may not result in death, be life-threat- ening, or require hospitalization may be considered serious
p.000134: when, based upon appropriate medical judgment, they may jeopardize the human subject and may require
...
p.000134: public, including any acronym or abbreviation used pub- licly to identify the clinical trial.
p.000134: (2) Official Title means the title of the clinical trial, corresponding to the title of the protocol.
p.000134: (3) Brief Summary means a short de- scription of the clinical trial, including a brief statement of the
p.000134: clinical trial’s hypothesis, written in language in- tended for the lay public.
p.000134: (4) Primary Purpose means the main objective of the intervention(s) being evaluated by the clinical trial.
p.000134: (5) Study Design means a description of the manner in which the clinical trial will be conducted,
p.000134: including the following information:
p.000134: (i) Interventional Study Model. The strategy for assigning interventions to human subjects.
p.000134: (ii) Number of Arms. The number of arms in the clinical trial. For a trial with multiple periods or
p.000134: phases that have different numbers of arms, it means the maximum number of arms during all periods or
p.000134: phases.
p.000134: (iii) Arm Information. A description of each arm of the clinical trial that indi- cates its role in the clinical
p.000134: trial, pro- vides an informative title, and, if nec- essary, additional descriptive informa- tion (including
p.000134: which interventions are
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p.000135:
p.000135:
p.000135:
p.000135:
p.000135:
p.000135:
p.000135:
p.000135:
p.000135: § 11.10
p.000135: administered in each arm) to differen- tiate each arm from other arms in the clinical trial.
p.000135: (iv) Allocation. The method by which human subjects are assigned to arms in a clinical trial.
p.000135: (v) Masking. The party or parties, if any, involved in the clinical trial who are prevented from having
p.000135: knowledge of the interventions assigned to indi- vidual human subjects.
p.000135: (6) Study Phase means, for a clinical trial of a drug product (including a bio- logical product), the
p.000135: numerical phase of such clinical trial, consistent with terminology in 21 CFR 312.21, such as phase 2 or
p.000135: phase 3, and in 21 CFR 312.85 for phase 4 studies.
p.000135: (7) Study Type means the nature of the investigation or investigational use for which clinical trial
p.000135: information is being submitted, e.g., interventional, observational.
p.000135: (8) Pediatric Postmarket Surveillance of a Device Product means a clinical trial or study that includes a
p.000135: U.S. FDA-reg- ulated device product as an interven- tion and is a pediatric postmarket sur- veillance of a
p.000135: device product ordered under section 522 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 369l).
p.000135: (9) Primary Disease or Condition Being
p.000135: Studied in the Trial, or the Focus of the Study means the name(s) of the dis- ease(s) or
p.000135: condition(s) studied in the clinical trial, or the focus of the clin- ical trial. Use, if available,
p.000135: appropriate descriptors from NLM’s Medical Sub- ject Headings (MeSH)-controlled vocab- ulary thesaurus or terms
p.000135: from another vocabulary, such as the Systematized Nomenclature of Medicine—Clinical Terms (SNOMED CT),
p.000135: that has been mapped to MeSH within the Unified Medical Language System (UMLS) Metathesaurus.
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p.000135: Interven- tion Name(s) and Other Intervention Name(s), sufficient to distinguish the intervention from
p.000135: other, similar inter- ventions studied in the same or an- other clinical trial. For example, inter-
p.000135: ventions involving drugs may include dosage form, dosage, frequency, and du- ration.
p.000135: (13) Intervention Type means, for each intervention studied in the clinical trial, the general type of
p.000135: intervention, e.g., drug, biological/vaccine, or, de- vice.
p.000135: (14) Device Product Not Approved or Cleared by U.S. FDA means that at least one device product
p.000135: studied in the clinical trial has not been previously approved or cleared by FDA for one or more uses.
p.000135: (15) Product Manufactured in and Ex- ported from the U.S. means that any drug product (including
p.000135: a biological product) or device product studied in the clinical trial is manufactured in the United
p.000135: States or one of its terri- tories and exported for study in a clin- ical trial in another country.
p.000135: (16) Study Start Date means the esti- mated date on which the clinical trial will be open for
p.000135: recruitment of human subjects, or the actual date on which the first human subject was enrolled.
p.000135: (17) Primary Completion Date means the estimated or actual primary com- pletion date. If an estimated
p.000135: primary completion date is used, the respon- sible party must update the Primary Completion Date
p.000135: data element once the clinical trial has reached the pri- mary completion date to reflect the ac- tual
p.000135: primary completion date.
p.000135: (18) Enrollment means the estimated total number of human subjects to be enrolled (target number) or the
p.000135: actual total number of human subjects that are enrolled in the clinical trial. Once the trial has reached
p.000135: the primary com- pletion date, the responsible party must update the Enrollment data ele- ment to
p.000135: reflect the actual number of human subjects enrolled in the clinical trial.
p.000136: 136
p.000136:
p.000136:
p.000136:
p.000136:
p.000136:
p.000136:
p.000136:
p.000136: Public Health Service, HHS § 11.10
p.000136:
p.000136:
p.000136: (19) Primary Outcome Measure Informa- tion means a description of each pri- mary outcome measure, to include
p.000136: the following information:
p.000136: (i) Name of the specific primary out- come measure;
p.000136: (ii) Description of the metric used to characterize the specific primary out- come measure; and
p.000136: (iii) Time point(s) at which the meas- urement is assessed for the specific metric used.
p.000136: (20) Secondary Outcome Measure Infor- mation means a description of each sec- ondary outcome measure, to
p.000136: include the following information:
p.000136: (i) Name of the specific secondary outcome measure;
p.000136: (ii) Description of the metric used to characterize the specific secondary outcome measure; and
p.000136: (iii) Time point(s) at which the meas- urement is assessed for the specific metric used.
p.000136: (21) Eligibility Criteria means a limited list of criteria for selection of human subjects to participate in
p.000136: the clinical trial, provided in terms of inclusion and exclusion criteria and suitable for assisting
p.000136: potential human subjects in identifying clinical trials of interest.
p.000136: (22) Sex/Gender means the sex and, if applicable, gender of the human sub- jects who may participate in
p.000136: the clin- ical trial.
...
p.000136: clinical trial, provided in relevant units of time.
p.000136: (24) Accepts Healthy Volunteers means that human subjects who do not have a disease or condition, or related
p.000136: condi- tions or symptoms, under study in the clinical trial are permitted to partici- pate in the clinical
p.000136: trial.
p.000136: (25) Overall Recruitment Status means the recruitment status for the clinical trial as a whole, based on the
p.000136: status of the individual sites. If at least one fa- cility in a multi-site clinical trial has an
p.000136: individual site status of ‘‘recruit- ing,’’ then the overall recruitment sta- tus for the trial must be
p.000136: ‘‘recruiting.’’
p.000136: (26) Why Study Stopped means, for a clinical trial that is suspended or ter- minated or withdrawn
p.000136: prior to its planned completion as anticipated by the protocol, a brief explanation of the
p.000136:
p.000136: reason(s) why the clinical trial was stopped.
p.000136: (27) Individual Site Status means the recruitment status of each partici- pating facility in a
p.000136: clinical trial.
p.000136: (28) Availability of Expanded Access means, for an applicable drug clinical trial of a drug product
p.000136: (including a bio- logical product) that is not an ap- proved drug product (including a bio- logical
p.000136: product), and for which the re- sponsible party is both the manufac- turer of the drug product
p.000136: (including a biological product) and the sponsor of the applicable clinical trial:
p.000136: (i) An indication of whether there is expanded access to the investigational drug product (including a
p.000136: biological product) under section 561 of the Fed- eral Food, Drug, and Cosmetic Act (21
p.000136: U.S.C. 360bbb) for those individuals who do not qualify for enrollment in the applicable clinical
p.000136: trial, under one or more of the following types of ex- panded access programs: for individual patients,
p.000136: including for emergency use, as specified in 21 CFR 312.310; for inter- mediate-size patient populations, as
p.000136: specified in 21 CFR 312.315; or under a treatment IND or treatment protocol, as specified in 21 CFR 312.320;
p.000136: and
p.000136: (ii) If expanded access is available under section 561 of the Federal Food, Drug, and Cosmetic
p.000136: Act (21 U.S.C. 360bbb), the NCT number of the ex- panded access record.
p.000136: (29) Name of the Sponsor means the name of the entity or individual who is the sponsor of the clinical
p.000136: trial, as de- fined in this part.
p.000136: (30) Responsible Party, by Official Title
p.000136: means an:
p.000136: (i) Indication of whether the respon- sible party is the sponsor of the clin- ical trial, as that term
p.000136: is defined in 21 CFR 50.3; the sponsor-investigator, as that term is defined in 21 CFR 50.3; or a
p.000136: principal investigator designated pursuant to this part; and
p.000136: (ii) Either:
p.000136: (A) The official name of the entity, if the responsible party is an entity; or
p.000136: (B) The official title and primary or- ganizational affiliation of the indi- vidual, if the responsible
p.000136: party is an in- dividual.
p.000136: (31) Facility Information means, for each participating facility in a clinical trial, the following
p.000136: information:
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p.000137:
p.000137:
p.000137:
p.000137:
p.000137:
p.000137:
p.000137:
p.000137:
p.000137: § 11.10
p.000137: (i) Facility Name, meaning the full name of the organization where the clinical trial is being
p.000137: conducted;
p.000137: (ii) Facility Location, including city, state, country and zip code for U.S. lo- cations (including territories
p.000137: of the United States) and city and country for locations in other countries; and
p.000137: (iii) Either:
p.000137: (A) For each facility participating in a clinical trial, Facility Contact, in- cluding the name or
p.000137: title, telephone number, and email address of a person to whom questions concerning the trial and enrollment
p.000137: at that site can be ad- dressed; or
p.000137: (B) Central Contact Person, including the name or title, toll-free telephone number, and email address of a
p.000137: person to whom questions concerning enroll- ment at any location of the trial can be addressed.
p.000137: (32) Unique Protocol Identification Number means any unique identifier as- signed to the protocol by the
p.000137: sponsor.
p.000137: (33) Secondary ID means:
p.000137: (i) Any identifier(s) other than the organization’s unique protocol identi- fier or NCT number that is assigned
p.000137: to the clinical trial, including any unique clinical trial identifiers assigned by other publicly available
p.000137: clinical trial registries. If the clinical trial is funded in whole or in part by a U.S. Federal Government
p.000137: agency, the complete grant or contract number must be sub- mitted as a Secondary ID.
p.000137: (ii) A description of the type of Sec- ondary ID.
p.000137: (34) U.S. Food and Drug Administration IND or IDE Number means an indication of whether there is an IND or IDE
p.000137: for the clinical trial and, if so, each of the following elements:
p.000137: (i) Name or abbreviation of the FDA center with whom the IND or IDE is filed;
p.000137: (ii) IND or IDE number assigned by the FDA center; and
p.000137: (iii) For an IND, the IND serial num- ber, as defined in 21 CFR 312.23(e), if any, assigned to the clinical
p.000137: trial.
p.000137: (35) Human Subjects Protection Revie Board Status means information to in- dicate whether a clinical trial
p.000137: has been reviewed and approved by a human sub- jects protection review board or wheth- er such review is not
p.000137: required per ap- plicable law (e.g., 21 CFR part 56, 45
p.000137: 42 CFR Ch. I (10–1–16 Edition)
p.000137: CFR part 46, or other applicable regula- tion). Human Subjects Protection Re- view Board Status must be listed
p.000137: as ‘‘approved’’ if at least one human sub- jects protection review board has ap- proved the clinical trial.
p.000137: (36) Record Verification Date means the date on which the responsible party last verified the clinical
p.000137: trial informa- tion in the entire ClinicalTrials.gov record for the clinical trial, even if no
p.000137: additional or updated information was submitted at that time.
p.000137: (37) Responsible Party Contact Informa- tion means administrative information to identify and allow
p.000137: communication with the responsible party by tele- phone, email, and regular mail or de- livery
p.000137: service. Responsible Party Con- tact Information includes the name, of- ficial title, organizational
p.000137: affiliation, physical address, mailing address, phone number, and email address of the individual who is
p.000137: the responsible party or of a designated employee of the or- ganization that is the responsible
p.000137: party.
p.000137: (38) Studies a U.S. FDA-regulated De-
p.000137: vice Product means that a clinical trial studies a device product subject to sec- tion 510(k), 515, or 520(m) of
p.000137: the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360(k), 21 U.S.C. 360e, 21 U.S.C. 360j(m)).
p.000137: (39) Studies a U.S. FDA-regulated Drug Product means a clinical trial studies a drug product (including a
p.000137: biological product) subject to section 505 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355) or
p.000137: section 351 of the Pub- lic Health Service Act (42 U.S.C. 262).
p.000137: (40) Post Prior to U.S. FDA Approval or Clearance means, for an applicable de- vice clinical trial of a
p.000137: device product that has not been previously approved or cleared, the responsible party indi- cates to the
p.000137: Director that it is author- izing the Director, in accordance with
p.000137: § 11.35(b)(2)(ii), to publicly post its clin- ical trial registration information, which would otherwise
p.000137: be subject to delayed posting, as specified in
p.000137: § 11.35(b)(2)(i), prior to the date of FDA approval or clearance of its device product.
p.000137: (41) Study Completion Date means the estimated or actual study completion date. Once the clinical
p.000137: trial has reached the study completion date, the
p.000138: 138
p.000138:
p.000138:
p.000138:
p.000138:
p.000138:
p.000138:
p.000138:
p.000138: Public Health Service, HHS § 11.24
p.000138:
p.000138:
p.000138: responsible party must update the Study Completion Date data element to reflect the actual study
p.000138: completion date in accordance with
p.000138: § 11.64(a)(1)(ii)(J) .
p.000138: Subpart B—Registration
p.000138: § 11.20 Who must submit clinical trial registration information?
p.000138: The responsible party for an applica- ble clinical trial specified in § 11.22 must submit clinical
p.000138: trial registration information for that clinical trial.
p.000138: § 11.22 Which applicable clinical trials must be registered?
p.000138: (a) General specification. (1) Any appli- cable clinical trial that is initiated after September 27, 2007,
p.000138: must be reg- istered.
p.000138: (2) Any applicable clinical trial that is initiated on or before September 27, 2007, and is ongoing on
p.000138: December 26, 2007, must be registered.
p.000138: (3) Determining the date of initiation for an applicable clinical trial. An appli- cable clinical
p.000138: trial, other than a pedi- atric postmarket surveillance of a de- vice product that is not a clinical trial, is
p.000138: considered to be initiated on the date on which the first human subject is enrolled. A pediatric
p.000138: postmarket sur- veillance of a device product that is not a clinical trial is considered to be initiated
p.000138: on the date on which FDA ap- proves the plan for conducting the sur- veillance.
p.000138: (b) Determination of applicable clinical
p.000138: trial for a clinical trial or study initiated on or after January 18, 2017. A clinical trial or study
p.000138: that, at any point in time, meets the conditions listed in paragraph (b)(1) or (2) of this
p.000138: section will be considered to meet the defini- tion of an applicable clinical trial.
p.000138: (1) Applicable device clinical trial. A clinical trial or study that meets the conditions listed in
p.000138: either paragraph (b)(1)(i) or (ii) of this section is an ap- plicable device clinical trial:
...
p.000138: (1) At least one Facility Location is within the United States or one of its territories,
p.000138: (2) A device product under investiga- tion is a Product Manufactured in and Exported from the U.S. or
p.000138: one of its territories for study in another coun- try, or
p.000138: (3) The clinical trial has a U.S. Food and Drug Administration IDE Number.
p.000138: (2) Applicable drug clinical trial. A clinical trial with one or more arms that meets the following
p.000138: conditions is an applicable drug clinical trial:
p.000138: (i) Study Type is interventional;
p.000138: (ii) Study Phase is other than phase
p.000138: 1;
p.000138: (iii) The clinical trial Studies a U.S.
p.000138: FDA-regulated Drug Product; and
p.000138: (iv) One or more of the following ap- plies:
p.000138: (A) At least one Facility Location for the clinical trial is within the United States or one of its territories,
p.000138: (B) A drug product (including a bio- logical product) under investigation is a Product Manufactured in
p.000138: and Ex- ported from the U.S. or one of its terri- tories for study in another country, or
p.000138: (C) The clinical trial has a U.S. Food and Drug Administration IND Number.
p.000138:
p.000138: § 11.24 When must clinical trial reg- istration information be submitted?
p.000138: (a) General. Except as provided in paragraph (b) of this section, the re- sponsible party for an
p.000138: applicable clin- ical trial for which submission of clin- ical trial registration information is
p.000138: required must submit the clinical trial registration information specified in section 402(j)(2)(A)(ii)
p.000138: of the Public Health Service Act (42 U.S.C. 282(j)(2)(A)(ii)) or § 11.28(a), as applica-
p.000138: ble, not later than December 26, 2007, or 21 calendar days after the first human subject is
p.000138: enrolled, whichever date is later.
p.000138: (b) Exceptions:. (1) The responsible party for an applicable clinical trial that is a clinical
p.000138: trial and for which
p.000139: 139
p.000139:
p.000139:
p.000139:
p.000139:
p.000139:
p.000139:
p.000139:
p.000139:
p.000139: § 11.28
p.000139: the submission of clinical trial reg- istration information is required and that is not for a
p.000139: serious or life-threat- ening disease or condition must submit clinical trial registration information as
p.000139: specified in section 402(j)(2)(A)(ii) of the Public Health Service Act (42 U.S.C.
p.000139: 282(j)(2)(A)(ii)) or § 11.28(a), as
p.000139: applicable, not later than September 27, 2008, or 21 calendar days after the first human subject is
p.000139: enrolled, which- ever date is later.
p.000139: (2) The responsible party for an appli- cable device clinical trial that is a pe- diatric postmarket
p.000139: surveillance of a device product and is not a clinical trial must submit clinical trial reg-
p.000139: istration information, as specified in section 402(j)(2)(A)(ii) of the Public Health Service
p.000139: Act (42 U.S.C. 282(j)(2)(A)(ii)) or § 11.28(b), not later than December 26, 2007, or 21
p.000139: calendar days after FDA approves the postmarket surveillance plan, which- ever date is later.
p.000139: § 11.28 What constitutes clinical trial registration information?
p.000139: (a) For each applicable clinical trial that must be registered with ClinicalTrials.gov, other
p.000139: than a pedi- atric postmarket surveillance of a de- vice product that is not a clinical trial, the responsible
p.000139: party must submit the following information:
p.000139: (1) For such applicable clinical trials that were initiated before January 18, 2017, the responsible party
p.000139: must submit the information specified in section 402(j)(2)(A)(ii) of the Public Health Service Act
p.000139: (42 U.S.C. 282(j)(2)(A)(ii)).
p.000139: (2) For such applicable clinical trials that are initiated on or after January 18, 2017, the
p.000139: responsible party must submit the data elements listed below:
p.000139: (i) Descriptive information:
p.000139: (A) Brief Title;
p.000139: (B) Official Title;
p.000139: (C) Brief Summary;
p.000139: (D) Primary Purpose;
p.000139: (E) Study Design;
p.000139: (F) Study Phase, for an applicable drug clinical trial;
p.000139: (G) Study Type;
p.000139: (H) Pediatric Postmarket Surveil- lance of a Device Product, for an appli- cable device clinical trial that
p.000139: is a Pe- diatric Postmarket Surveillance of a Device Product;
p.000139: 42 CFR Ch. I (10–1–16 Edition)
p.000139: (I) Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study;
p.000139: (J) Intervention Name(s), for each intervention studied;
p.000139: (K) Other Intervention Name(s), for each intervention studied;
p.000139: (L) Intervention Description, for each intervention studied;
p.000139: (M) Intervention Type, for each intervention studied;
p.000139: (N) Studies a U.S. FDA-regulated De- vice Product;
p.000139: (O) Studies a U.S. FDA-regulated Drug Product;
p.000139: (P) Device Product Not Approved or Cleared by U.S. FDA, if any studied intervention is a device product;
p.000139: (Q) Post Prior to U.S. FDA Approval or Clearance, for an applicable device clinical trial that studies
p.000139: at least one device product not previously approved or cleared by the U.S. FDA;
p.000139: (R) Product Manufactured in and Ex- ported from the U.S., if the entry for
p.000139: U.S. Food and Drug Administration IND or IDE Number in
...
p.000139: territories;
p.000139: (S) Study Start Date;
p.000139: (T) Primary Completion Date;
p.000139: (U) Study Completion Date;
p.000139: (V) Enrollment;
p.000139: (W) Primary Outcome Measure Infor- mation, for each primary outcome measure; and
p.000139: (X) Secondary Outcome Measure In- formation, for each secondary outcome measure.
p.000139: (ii) Recruitment information:
p.000139: (A) Eligibility Criteria;
p.000139: (B) Sex/Gender;
p.000139: (C) Age Limits;
p.000139: (D) Accepts Healthy Volunteers;
p.000139: (E) Overall Recruitment Status;
p.000139: (F) Why Study Stopped;
p.000139: (G) Individual Site Status; and
p.000139: (H) Availability of Expanded Access. If expanded access is available for an investigational drug product
p.000139: (including a biological product), an expanded ac- cess record must be submitted in ac- cordance with §
p.000139: 11.28(c), unless an ex- panded access record was submitted
p.000140: 140
p.000140:
p.000140:
p.000140:
p.000140:
p.000140:
p.000140:
p.000140:
p.000140: Public Health Service, HHS § 11.28
p.000140:
p.000140:
p.000140: previously in accordance with that pro- vision.
p.000140: (iii) Location and contact informa- tion:
p.000140: (A) Name of the Sponsor;
p.000140: (B) Responsible Party, by Official Title; and
p.000140: (C) Facility Information.
p.000140: (iv) Administrative data:
p.000140: (A) Unique Protocol Identification Number;
p.000140: (B) Secondary ID;
p.000140: (C) U.S. Food and Drug Administra- tion IND or IDE Number;
p.000140: (D) Human Subjects Protection Re- view Board Status;
p.000140: (E) Record Verification Date; and
p.000140: (F) Responsible Party Contact Infor- mation.
p.000140: (b) Pediatric postmarket surveillance of a device product that is not a clin- ical trial. For
p.000140: each pediatric postmarket surveillance of a device product that is not a clinical trial, the responsible
p.000140: party must submit the fol- lowing information:
p.000140: (1) For such applicable device clinical trials that were initiated before Janu- ary 18, 2017, the responsible
p.000140: party must submit the information specified in section 402(j)(2)(A)(ii) of the Public Health
p.000140: Service Act (42 U.S.C. 282(j)(2)(A)(ii)).
p.000140: (2) For such applicable device clinical trials that are initiated on or after January 18, 2017, the
p.000140: responsible party must submit the data elements listed below:
p.000140: (i) Descriptive information:
p.000140: (A) Brief Title. A short title of the pe- diatric postmarket surveillance of a device product in language
p.000140: intended for the lay public. If an acronym or abbre- viation is used to publicly identify the surveillance, it
p.000140: must be provided.
p.000140: (B) Official Title. The title of the pedi- atric postmarket surveillance of a de- vice product, corresponding to
p.000140: the title of the protocol or the FDA-approved plan for conducting the surveillance
p.000140: (C) Brief Summary. A short descrip- tion of the pediatric postmarket sur- veillance of a device product,
p.000140: including a brief statement of the hypothesis or objective, written in language intended for the lay public,
p.000140: and a general de- scription of the surveillance design, in- cluding relevant population informa- tion
p.000140:
p.000140: (D) Study Type. The type of study being registered. In the case of a pedi- atric postmarket
p.000140: surveillance of a de- vice product that is not a clinical trial, a study type of ‘‘observational’’ is re-
p.000140: quired.
p.000140: (E) Pediatric Postmarket Surveillance of a Device Product. For a study that in- cludes an FDA-regulated
p.000140: device prod- uct as an intervention and is a pedi- atric postmarket surveillance of a de- vice product
p.000140: (F) Primary Disease or Condition Being Studied, or the Focus of the Study. The name(s) of the
p.000140: disease(s) or condi- tion(s) being studied in the pediatric postmarket surveillance of a device
...
p.000140: (H) Other Intervention Name(s). Any other current and former name(s) or alias(es), different from the
p.000140: Interven- tion Name(s), that the sponsor has used publicly to identify the intervention(s), including, but not
p.000140: limited to, past or present names such as brand name(s), or serial numbers
p.000140: (I) Intervention Description. Details that can be made public about each intervention, other than
p.000140: the Interven- tion Name(s) and Other Intervention Name(s), sufficient to distinguish the intervention
p.000140: from other, similar inter- ventions studied in the same or an- other clinical trial or
p.000140: pediatric postmarket surveillance of a device product that is not a clinical trial
p.000140: (J) Intervention Type. For each inter- vention studied in the pediatric postmarket surveillance
p.000140: of a device product, the general type of interven- tion
p.000140: (K) Study Start Date. The date on which FDA approves the pediatric
p.000141: 141
p.000141:
p.000141:
p.000141:
p.000141:
p.000141:
p.000141:
p.000141:
p.000141:
p.000141: § 11.28
p.000141: postmarket surveillance plan, as speci- fied in 21 CFR 822.19(a).
p.000141: (L) Primary Completion Date. The esti- mated or actual date on which the final report of the pediatric postmarket sur-
p.000141: veillance of a device product is ex- pected to be submitted to FDA. Once the final report has
p.000141: been submitted, this is the actual date on which the final report is submitted to FDA.
p.000141: (ii) Location and contact informa- tion:
p.000141: (A) Name of the Sponsor.
p.000141: (B) Responsible Party, by Official Title:
p.000141: (1) If the responsible party is an enti- ty, the official name of the entity; or
p.000141: (2) If the responsible party is an indi- vidual, the official title and primary organizational affiliation of
p.000141: the indi- vidual.
p.000141: (C) Contact Information. The name or official title, toll-free telephone num- ber, and email address of a
p.000141: person to whom questions concerning the pedi- atric postmarket surveillance of a de- vice product can be
p.000141: addressed.
p.000141: (iii) Administrative data:
p.000141: (A) Unique Protocol Identification Number. The unique identifier assigned to the pediatric
p.000141: postmarket surveil- lance of a device product by the spon- sor, if any.
p.000141: (B) Secondary ID: (1) Identifier(s) other than the organization’s unique protocol identifier or NCT
p.000141: number that is assigned to the pediatric postmarket surveillance of a device product, if any, including any unique
p.000141: identifiers as- signed by other publicly available clin- ical study registries. If the pediatric postmarket
p.000141: surveillance of a device product is funded in whole or in part by a U.S. Federal Government agency, the complete
p.000141: grant or contract number must be submitted as a Secondary ID.
p.000141: (2) For each secondary ID listed, a de-
p.000141: scription of the type of secondary ID.
p.000141: (C) Human Subjects Protection Revie Board Status. Information to indicate whether a pediatric
p.000141: postmarket sur- veillance of a device product has been reviewed and approved by a human sub- jects protection
p.000141: review board or wheth- er such review is not required per ap- plicable law (e.g., 21 CFR part 56, 45 CFR
p.000141: part 46, or other applicable regula- tion). Human Subjects Protection Re- view Board Status must be listed as
p.000141: 42 CFR Ch. I (10–1–16 Edition)
p.000141: ‘‘approved’’ if at least one human sub- jects protection review board has ap- proved the pediatric
p.000141: postmarket sur- veillance.
p.000141: (D) Record Verification Date. The date on which the responsible party last verified the clinical
p.000141: trial information in the entire ClinicalTrials.gov record for the pediatric postmarket surveil- lance of a
p.000141: device product, even if no ad- ditional or updated information was submitted at that time
p.000141: (E) Responsible Party Contact Informa- tion. Administrative information suffi- cient to identify and allow
p.000141: communica- tion with the responsible party by tele- phone, email, and regular mail or de- livery service.
p.000141: Responsible Party Con- tact Information includes the name, of- ficial title, organizational affiliation,
p.000141: physical address, mailing address, phone number, and email address of the individual who is the responsible
p.000141: party or of a designated employee of the or- ganization that is the responsible party.
p.000141: (c) Expanded access record. If ex- panded access is available, as specified in 21 CFR 312.315
p.000141: (for an intermediate- size patient population) or 21 CFR
p.000141: 312.320 (under a treatment IND or treatment protocol), for an investiga- tional drug product
p.000141: (including a bio- logical product) studied in an applica- ble drug clinical trial, and the data ele- ments set
p.000141: forth in paragraphs (c)(1) through (4) of this section have not been submitted in an expanded
p.000141: access record for that investigational product, the responsible party, if both the man- ufacturer of the
p.000141: investigational prod- uct and the sponsor of the applicable clinical trial, must submit the clinical trial
p.000141: information specified in para- graphs (c)(1) through (4) of this section to ClinicalTrials.gov in the form
p.000141: of an expanded access record. If expanded ac- cess is available only as specified in 21 CFR 312.310 (for
p.000141: individual patients, in- cluding for emergency use) for an in- vestigational drug product (including a biological
p.000141: product) studied in an appli- cable drug clinical trial, and the data elements set forth in
p.000141: paragraphs (c)(1)(i), (iii), (iv), (vi), (ix), (x), (c)(2)(iv), (c)(3), (c)(4)(i), (iii),(iv),
p.000141: and
p.000141: (v) of this section have not been sub-
p.000141: mitted in an expanded access record for
p.000142: 142
p.000142:
p.000142:
p.000142:
p.000142:
p.000142:
p.000142:
p.000142:
p.000142: Public Health Service, HHS § 11.28
p.000142:
p.000142:
p.000142: that investigational product, the re- sponsible party, if both the manufac- turer of the
p.000142: investigational product and the sponsor of the applicable clin- ical trial, must submit the clinical
p.000142: trial information specified in those paragraphs to ClinicalTrials.gov in the form of an expanded access
p.000142: record.
p.000142: (1) Descriptive information:
p.000142: (i) Brief Title. A short title identi- fying the expanded access, written in language intended for the
p.000142: lay public. If an acronym or abbreviation is used publicly to identify the expanded ac- cess, it must be
p.000142: provided.
p.000142: (ii) Official Title. The title, if any, of the expanded access program cor- responding to the
p.000142: title that has been submitted to FDA for that program
p.000142: (iii) Brief Summary. A short descrip- tion of the availability of expanded ac- cess, including the procedure
p.000142: for re- questing the investigational drug prod- uct (including a biological product).
p.000142: (iv) Study Type. The nature of the in- vestigation or investigational use for which clinical trial
p.000142: information is being submitted, i.e., ‘‘expanded ac- cess’’.
p.000142: (v) Primary Disease or Condition. The name(s) of the disease(s) or condi- tion(s) for which
p.000142: expanded access to the investigational drug product (in- cluding a biological product) is avail- able.
...
p.000142: (2) Recruitment information:
p.000142: (i) Eligibility Criteria. A limited list of criteria for determining who is eligible to receive the
p.000142: investigational drug product (including a biological prod- uct) through expanded access, provided in terms
p.000142: of inclusion and exclusion cri- teria and suitable for assisting poten- tial patients in identifying
p.000142: investiga- tional drug products (including biologi- cal products) of interest for which ex- panded access is
p.000142: available.
p.000142: (ii) Sex/Gender. The sex and gender (if applicable) of the patients for whom expanded access is available.
p.000142: (iii) Age Limits. The minimum and maximum age of patients for whom ex- panded access is available,
p.000142: provided in relevant units of time.
p.000142: (iv) Expanded Access Status. The sta- tus of availability of the investiga- tional drug product
p.000142: (including a bio- logical product) through expanded ac- cess.
p.000142: (3) Contact information:
p.000142: (i) Name of the Sponsor.
p.000142: (ii) Responsible Party, by Official Title.
p.000142: The official name of the entity.
p.000142: (iii) Contact Information. The name or official title, toll-free telephone num- ber, and email address of a
p.000142: person to whom questions concerning expanded access can be addressed.
p.000142: (4) Administrative data:
p.000142: (i) Unique Protocol Identification Num- ber. Any unique identifier assigned by the sponsor to refer to
p.000142: the availability of its investigational drug product (in- cluding a biological product) for ex- panded
p.000142: access use or to identify the ex- panded access record.
p.000143: 143
p.000143:
p.000143:
p.000143:
p.000143:
p.000143:
p.000143:
p.000143:
p.000143:
p.000143: § 11.35
p.000143: (ii) Secondary ID: (A) Any identi- fier(s) other than the Unique Protocol Identification Number or
p.000143: the NCT number that is assigned to the ex- panded access record, including any unique
p.000143: identifiers assigned by other publicly available clinical trial or ex- panded access registries.
p.000143: (B) For each Secondary ID listed, a description of the type of Secondary ID.
p.000143: (iii) U.S. Food and Drug Administra- tion IND Number. An indication of whether there is an IND
p.000143: and, if so, each of the following elements:
p.000143: (A) Name or abbreviation of the FDA center with whom the IND is filed (i.e., CDER or CBER), if applicable;
p.000143: (B) IND number (assigned by the FDA center) under which the investiga- tional drug product (including a
p.000143: bio- logical product) is being made avail- able for expanded access, if applicable; and
p.000143: (C) IND serial number. as defined in 21 CFR 312.23(e), if any, assigned to the expanded access.
p.000143: (iv) Record Verification Date. The date on which the responsible party last verified the information
p.000143: in the ex- panded access record, even if no addi- tional or updated information was sub- mitted at that time.
p.000143: (v) Responsible Party Contact Informa- tion. Administrative information suffi- cient to identify and allow
p.000143: communica- tion with the responsible party enter- ing the clinical trial information into the expanded
p.000143: access record by tele- phone, email, and regular mail or de- livery service. Responsible Party Con-
p.000143: tact Information includes the name, of- ficial title, organizational affiliation, physical address,
p.000143: mailing address, phone number, and email address of the individual who is the responsible party or of a
p.000143: designated employee of the or- ganization that is the responsible party.
p.000143: § 11.35 By when will the NIH Director post clinical trial registration infor- mation submitted under § 11.28?
p.000143: (a) Applicable drug clinical trial. The Director will post publicly on ClinicalTrials.gov the
p.000143: clinical trial reg- istration information, except for cer- tain administrative data, for an appli- cable
p.000143: drug clinical trial not later than
p.000143: 42 CFR Ch. I (10–1–16 Edition)
p.000143: 30 calendar days after the responsible party has submitted such information, as specified in § 11.24.
p.000143: (b) Applicable device clinical trial. (1) For an applicable device clinical trial of a device product that
p.000143: was previously approved or cleared, the Director will post publicly on ClinicalTrials.gov the clinical trial
p.000143: registration information, except for certain administrative data, as soon as practicable, but not later
p.000143: than 30 calendar days after clinical trial results information is required to be posted, as specified in
p.000143: § 11.52.
p.000143: (2) For an applicable device clinical trial of a device product that has not been previously approved or
p.000143: cleared:
p.000143: (i) The Director will post publicly on ClinicalTrials.gov the clinical trial reg- istration information, except
p.000143: for cer- tain administrative data, not earlier than the date of FDA approval or clear- ance of the
p.000143: device product and not later than 30 calendar days after the date of such approval or clearance, ex-
p.000143: cept as otherwise provided in para- graph (b)(2)(ii) of this section.
p.000143: (ii) If, prior to the date of approval or clearance of the device product, the re- sponsible party for an
p.000143: applicable clin- ical trial that is initiated on or after January 18, 2017, indicates to the Direc- tor, by
p.000143: submitting the Post Prior to
p.000143: U.S. FDA Approval or Clearance data element under § 11.28(a)(2)(i)(Q), that it is authorizing the Director
p.000143: to publicly post its clinical trial registration in- formation, which would otherwise be subject to
p.000143: delayed posting as specified in paragraph (b)(2)(i) of this section, prior to the date of FDA
p.000143: approval or clearance of its device product, the Di- rector will publicly post the registra- tion information,
p.000143: except for certain ad- ministrative data, as soon as prac- ticable.
p.000143:
p.000143: Subpart C—Results Information Submission
p.000143: § 11.40 Who must submit clinical trial results information?
p.000143: The responsible party for an applica- ble clinical trial specified in § 11.42 must submit clinical trial
p.000143: results infor- mation for that clinical trial.
p.000144: 144
p.000144:
p.000144:
p.000144:
p.000144:
p.000144:
p.000144:
p.000144:
p.000144: Public Health Service, HHS § 11.44
p.000144:
p.000144:
p.000144: § 11.42 For which applicable clinical trials must clinical trial results in- formation be submitted?
p.000144: (a) Applicable clinical trials for hich the studied product is approved, licensed, or cleared by FDA.
p.000144: Unless a waiver of the requirement to submit clinical trial results information is granted in
p.000144: accordance with § 11.54, clinical trial results information must be submitted for any applicable
p.000144: clinical trial for which the studied product is approved, licensed, or cleared by FDA for which
p.000144: submission of clinical trial registration information is required in accordance with the following:
p.000144: (1) If the primary completion date is before January 18, 2017, the responsible party must submit the clinical
p.000144: trial re- sults information specified in sections 402(j)(3)(C) and 402(j)(3)(I) of the Public Health
p.000144: Service Act (42 U.S.C. 282(j)(3)(C) and 42 U.S.C. 282(j)(3)(I)); or
p.000144: (2) If the primary completion date is on or after January 18, 2017, the respon- sible party must submit
p.000144: the clinical trial results information specified in
p.000144: § 11.48.
p.000144: (b) Applicable clinical trials for hich the studied product is not approved, li- censed, or cleared
p.000144: by FDA. Unless a waiver of the requirement to submit clinical trial results information is granted
p.000144: in accordance with § 11.54, clin- ical trial results information specified in § 11.48 must be submitted for any ap-
p.000144: plicable clinical trial with a primary completion date on or after January 18, 2017 for which clinical trial
p.000144: registra- tion information is required to be sub- mitted and for which the studied prod- uct is not
p.000144: approved, licensed, or cleared by FDA.
p.000144: § 11.44 When must clinical trial results information be submitted for appli- cable clinical trials
p.000144: subject to
p.000144: § 11.42?
p.000144: (a) Standard submission deadline. In general, for applicable clinical trials subject to § 11.42,
p.000144: clinical trial results information specified in sections 402(j)(3)(C) and 402(j)(3)(I) of the
p.000144: Public Health Service Act (42 U.S.C. 282(j)(3)(C) and 42 U.S.C. 282(j)(3)(I)) or in § 11.48,
p.000144: as applicable, must be sub- mitted no later than 1 year after the primary completion date of the appli-
p.000144: cable clinical trial.
p.000144:
p.000144: (b) Delayed submission of results infor- mation ith certification if seeking ap- proval, licensure,
p.000144: or clearance of a ne use—(1) General requirements. If, prior to the results information submission
p.000144: deadline specified under paragraph (a) of this section, the responsible party submits a certification that an
p.000144: applica- ble clinical trial involves an FDA-regu- lated drug product (including a biologi- cal product) or device
p.000144: product that pre- viously has been approved, licensed, or cleared, for which the manufacturer is the sponsor
p.000144: of the applicable clinical trial and for which an application or premarket notification seeking ap-
p.000144: proval, licensure, or clearance of the use being studied (which is not in- cluded in the labeling
p.000144: of the approved, licensed, or cleared drug product (in- cluding a biological product) or device product)
p.000144: has been filed or will be filed within 1 year with FDA, the deadline for submitting clinical trial
p.000144: results in- formation, as specified in sections 402(j)(3)(C) and 402(j)(3)(I) of the Public Health
p.000144: Service Act (42 U.S.C. 282(j)(3)(C) and 42 U.S.C. 282(j)(3)(I)) or
p.000144: § 11.48, as applicable, will be 30 calendar days after the earliest of the following events:
p.000144: (i) FDA approves, licenses, or clears the drug product (including a biologi- cal product) or device
p.000144: product for the use studied in the applicable clinical trial;
p.000144: (ii) FDA issues a letter that ends the regulatory review cycle for the applica- tion or submission but does
p.000144: not ap- prove, license, or clear the drug prod- uct (including a biological product) or device product
p.000144: for the use studied in the applicable clinical trial; or
p.000144: (iii) The application or premarket notification seeking approval, licen- sure, or clearance of the
p.000144: new use is withdrawn without resubmission for not less than 210 calendar days.
p.000144: (2) T o-year limitation. Notwith- standing the deadlines specified in paragraph (b)(1) of
p.000144: this section, the re- sponsible party must submit clinical trial results information specified in
p.000144: paragraph (b)(1) of this section not later than the date that is 2 years after the date that the
p.000144: certification was sub- mitted, except to the extent that para- graph (d) of this section applies.
p.000145: 145
p.000145:
p.000145:
p.000145:
p.000145:
p.000145:
p.000145:
p.000145:
p.000145:
p.000145: § 11.44
p.000145: (3) Additional requirements. If a re- sponsible party who is both the manu- facturer of the drug
p.000145: product (including a biological product) or device product studied in an applicable clinical trial and the
p.000145: sponsor of the applicable clin- ical trial submits a certification in ac- cordance with paragraph (b)(1)
p.000145: of this section, that responsible party must submit such a certification for each ap- plicable clinical
p.000145: trial that meets the following criteria:
p.000145: (i) The applicable clinical trial is re- quired to be submitted in an applica- tion or premarket
p.000145: notification seeking approval, licensure, or clearance of a new use; and
p.000145: (ii) The applicable clinical trial stud- ies the same drug product (including a biological product) or
p.000145: device product for the same use as studied in the ap- plicable clinical trial for which the ini- tial
p.000145: certification was submitted.
p.000145: (c) Delayed submission of results ith
p.000145: certification if seeking initial approval, li- censure, or clearance.—(1) General re- quirements. If,
p.000145: prior to the submission deadline specified under paragraph (a) of this section, a responsible party sub- mits a
p.000145: certification that an applicable clinical trial studies an FDA-regulated drug product (including a
p.000145: biological product) or device product that was not approved, licensed, or cleared by FDA for any use before the
p.000145: primary comple- tion date of the trial, and that the sponsor intends to continue with prod- uct
p.000145: development and is either seeking, or may at a future date seek, FDA ap- proval, licensure, or clearance
p.000145: of the drug product (including a biological product) or device product under study, the deadline for
p.000145: submitting clinical trial results information, as specified in § 11.48, will be 30 calendar days after the
p.000145: earlier of the date on which:
p.000145: (i) FDA approves, licenses, or clears
p.000145: the drug product (including a biologi- cal product) or device product for any use that is studied in
p.000145: the applicable clinical trial; or
p.000145: (ii) The marketing application or premarket notification is withdrawn without resubmission for not
p.000145: less than 210 calendar days.
p.000145: (2) T o-year limitation. Notwith- standing the deadlines established in paragraph (c)(1) of this
p.000145: section, the re- sponsible party must submit clinical
p.000145: 42 CFR Ch. I (10–1–16 Edition)
p.000145: trial results information specified in paragraph (c)(1) of this section not later than 2 years
p.000145: after the date on which the certification was submitted, except to the extent that paragraph (d) of this section
p.000145: applies.
p.000145: (d) Submitting partial results informa- tion. (1) If clinical trial results infor- mation specified in
p.000145: sections 402(j)(3)(C) and 402(j)(3)(I) of the Public Health Service Act (42 U.S.C. 282(j)(3)(C) and 42
p.000145: U.S.C. 282(j)(3)(I)) or § 11.48, as applica- ble, has not been collected for a sec- ondary outcome
p.000145: measure(s) or addi- tional adverse event information by the primary completion date, the re- sponsible
p.000145: party must submit the re- maining required clinical trial results information for secondary
p.000145: outcome measure(s) or additional adverse event information for that clinical trial by the following deadlines:
p.000145: (i) For secondary outcome meas- ure(s), by the later of:
p.000145: (A) One year after the date on which the final subject is examined or re- ceives an intervention for
p.000145: the purposes of final collection of data for that sec- ondary outcome measure, whether the clinical trial
p.000145: was concluded according to the pre-specified protocol or was ter- minated; or
p.000145: (B) If a certification to delay results information submission has been sub- mitted under paragraph (b)
p.000145: or (c) of this section, the date on which results information for the primary outcome measures is due
p.000145: pursuant to paragraph
p.000145: (b) or (c) of this section.
p.000145: (ii) For additional adverse event in- formation, by the later of:
p.000145: (A) One year after the date of data collection for additional adverse event information, whether the
p.000145: clinical trial was concluded according to the pre- specified protocol or was terminated; or
p.000145: (B) If a certification to delay results information submission has been sub- mitted under paragraph (b)
p.000145: or (c) of this section, the date on which results information for the primary outcome measures is due
p.000145: pursuant to paragraph
p.000145: (b) or (c) of this section.
p.000145: (2) Except, if clinical trial results in- formation was submitted for the pri- mary outcome measure(s) prior
p.000145: to the effective date of these regulations but data collection for all of the secondary
p.000146: 146
p.000146:
p.000146:
p.000146:
p.000146:
p.000146:
p.000146:
p.000146:
p.000146: Public Health Service, HHS § 11.44
p.000146:
p.000146:
p.000146: outcome measure(s) or additional ad- verse event information is not com- pleted until on or after
p.000146: January 18, 2017, clinical trial results information for all primary and secondary outcome measures and
p.000146: adverse event informa- tion for the clinical trial must be sub- mitted as specified in
p.000146: sections 402(j)(3)(C) and 402(j)(3)(I) of the Public Health Service Act (42 U.S.C.
p.000146: 282(j)(3)(C) and 42 U.S.C. 282(j)(3)(I)).
p.000146: (3) For each submission of partial re- sults information for a clinical trial, as specified in paragraph (d)(1) of this
p.000146: sec- tion:
p.000146: (i) If any amendments were made to the protocol and/or statistical analysis plan as described in §
p.000146: 11.48(a)(5) since the previous submission of partial re- sults information, the responsible party
p.000146: must submit a copy of the re- vised protocol and/or statistical anal- ysis plan; and
p.000146: (ii) If information about certain agreements as described in
p.000146: § 11.48(a)(6)(ii) has changed since the previous submission of partial results information, the
p.000146: responsible party must submit information to reflect the new status of certain agreements be- tween the
p.000146: principal investigator and the sponsor.
p.000146: (e) Extensions for good cause. (1) A re- sponsible party may request an exten- sion of the deadline
p.000146: for submitting clinical trial results information sub- ject to paragraphs (e)(1)(i) and (ii) of this
p.000146: section or section 402(j)(3)(E)(vi) of the Public Health Service Act (42
p.000146: U.S.C. 282(j)(3)(E)(vi)), as applicable, and may request more than one exten- sion for the same
p.000146: applicable clinical trial.
p.000146: (i) The responsible party must sub- mit a request for an extension to ClinicalTrials.gov prior to
p.000146: the date on which clinical trial results information would otherwise be due in accordance with paragraph (a),
p.000146: (b), (c), (d), (e), or
p.000146: (f) of this section.
p.000146: (ii) A request for an extension must contain the following:
p.000146: (A) Description of the reason(s) why clinical trial results information can- not be provided according to
p.000146: the dead- line, with sufficient detail to allow for the evaluation of the request; and
p.000146:
p.000146: (B) Estimate of the date on which the clinical trial results information will be submitted.
p.000146: (2) Decision and submission deadline. The Director will provide a response electronically to the
p.000146: responsible party indicating whether the requested ex- tension demonstrates good cause and has been
p.000146: granted.
p.000146: (i) If the extension request is grant- ed, the responsible party must submit clinical trial results
p.000146: information not later than the date of the deadline specified in the electronic response.
p.000146: (ii) If the extension request is denied, the responsible party must either ap- peal in accordance with
p.000146: paragraph (e)(3) of this section or submit clinical trial results information specified in
p.000146: § 11.48 by the later of the submission deadline specified in paragraph (a), (b), (c), (d), (e), or (f) of this
p.000146: section, as ap- plicable, or 30 calendar days after the date on which the electronic notice of the denial
p.000146: is sent to the responsible party.
p.000146: (3) Appealing a denied extension re- quest. (i) A responsible party who seeks to appeal a denied extension
p.000146: request or the deadline specified in a granted ex- tension must submit an appeal to the Director in the
p.000146: format specified at https://prsinfo.clinicaltrials.gov/ not later than 30 calendar days after the date on which
p.000146: the electronic notification of the granting or denial of the request is sent to the responsible party.
p.000146: (ii) An appeal must contain an expla- nation of the reason(s) why the initial decision to deny the extension
p.000146: request or to grant the extension request with a shorter deadline than requested should be
p.000146: overturned or revised, with sufficient detail to allow for the eval- uation of the appeal.
p.000146: (iii) The Director will provide an electronic notification to the respon- sible party indicating
p.000146: whether the re- quested extension has been granted upon appeal.
p.000146: (iv) If the Director grants the exten- sion request upon appeal, the respon- sible party must submit
p.000146: clinical trial results information not later than the deadline specified in the electronic no- tification
p.000146: specified in paragraph (e)(3)(iii) of this section.
p.000147: 147
p.000147:
p.000147:
p.000147:
p.000147:
p.000147:
p.000147:
p.000147:
p.000147:
p.000147: § 11.48
p.000147: (v) If the Director denies the appeal of a denied extension request, the re- sponsible party must
p.000147: submit clinical trial results information by the later of the deadline specified in paragraph (a), (b), (c), (d),
p.000147: (e), or (f) of this section, or
p.000147: 30 calendar days after the electronic notification of the denial of the appeal, specified in paragraph
p.000147: (e)(3)(iii) of this section, is sent to the responsible party.
p.000147: (vi) If the Director denies an appeal of a denied deadline specified in a granted extension
p.000147: request, the respon- sible party must submit clinical trial results information by the later of the
p.000147: deadline specified in the notification granting the extension request, speci- fied in paragraph
p.000147: (e)(2)(i) of this sec- tion, or 30 calendar days after the elec- tronic notification denying the appeal,
p.000147: specified in paragraph (e)(3)(iii) of this section, is sent to the responsible party.
p.000147: (f) Pediatric postmarket surveillance of
p.000147: a device product that is not a clinical trial. For each pediatric postmarket surveillance of a
p.000147: device product that is not a clinical trial as defined in this part, the responsible party must sub- mit
p.000147: clinical trial results information as specified in § 11.48(b) or section 402(j)(C)(3) of the Public
p.000147: Health Service Act (42 U.S.C. 282(j)(C)(3)), as applica- ble, not later than 30 calendar days after
p.000147: the date on which the final report of the approved pediatric postmarket surveillance of a device product,
p.000147: as specified in 21 CFR 822.38, is submitted to FDA.
p.000147: § 11.48 What constitutes clinical trial results information?
p.000147: (a) For each applicable clinical trial, other than a pediatric postmarket sur- veillance of a device
p.000147: product that is not a clinical trial, for which clinical trial results information must be sub- mitted
p.000147: under § 11.42, the responsible party must provide the following:
p.000147: (1) Participant flo . Information for completing a table documenting the progress of human subjects
p.000147: through a clinical trial, by arm, including the number who started and completed the clinical trial.
p.000147: This information must include the following elements:
p.000147: (i) Participant Flo Arm Information.
p.000147: A brief description of each arm used for
p.000147: 42 CFR Ch. I (10–1–16 Edition)
p.000147: describing the flow of human subjects through the clinical trial, including a descriptive title used to
p.000147: identify each arm;
p.000147: (ii) Pre-assignment Information. A de- scription of significant events in the clinical trial that occur
p.000147: after enroll- ment and prior to assignment of human subjects to an arm, if any; and
p.000147: (iii) Participant Data. The number of human subjects that started and com- pleted the clinical trial, by
p.000147: arm. If as- signment is based on a unit other than participants, also include a description of the unit of assignment
p.000147: and the num- ber of units that started and completed the clinical trial, by arm.
p.000147: (2) Demographic and baseline charac- teristics. Information for completing a table of demographic
p.000147: and baseline measures and data collected by arm or comparison group and for the entire population
p.000147: of human subjects who par- ticipated in the clinical trial. This in- formation must include the following
p.000147: elements:
p.000147: (i) Baseline Characteristics Arm/Group Information. A brief description of each arm or comparison group
p.000147: used for de- scribing the demographic and baseline characteristics of the human subjects in the clinical
...
p.000148: description of the reason(s) for the difference.
p.000148: (iii) Outcome Measure Information. A description of each outcome measure, to include the following elements:
p.000148: (A) Name of the specific outcome measure, including the titles of any categories in which
p.000148: Outcome Measure Data in § 11.48(a)(3)(iv) are aggregated.
p.000148: (B) Description of the metric used to characterize the specific outcome measure.
p.000148: (C) Time point(s) at which the meas- urement was assessed for the specific metric.
p.000148: (D) Outcome Measure Type. The type of outcome measure, whether primary, secondary, other pre-specified, or
p.000148: post- hoc.
p.000148: (E) Measure Type and Measure of Dis- persion or Precision. For each outcome measure for which data are
p.000148: collected, the type of data submitted and the measure of dispersion or precision.
p.000148: (F) Unit of Measure. For each out- come measure for which data are col- lected, the unit of measure.
p.000148: (iv) Outcome Measure Data. The meas- urement value(s) for each outcome measure for which data are
p.000148: collected, by arm or comparison group and by category (if specified).
p.000148: (v) Statistical Analyses. Result(s) of scientifically appropriate tests of the statistical significance
p.000148: of the primary and secondary outcome measures, if any.
p.000148: (A) A statistical analysis is required to be submitted if it is:
p.000148: (1) Pre-specified in the protocol and/ or statistical analysis plan and was performed on the
p.000148: outcome measure data,
p.000148: (2) Made public by the sponsor or re- sponsible party prior to the date on which clinical trial
p.000148: results information is submitted for the primary outcome measures(s) studied in the clinical trial to which
p.000148: the statistical analysis ap- plies, or
p.000148: (3) Conducted on a primary outcome measure in response to a request made
p.000149: 149
p.000149:
p.000149:
p.000149:
p.000149:
p.000149:
p.000149:
p.000149:
p.000149:
p.000149: § 11.48
p.000149: by FDA prior to the date on which clin- ical trial results information is sub- mitted for the primary
p.000149: outcome meas- ure(s) studied in the clinical trial to which the statistical analysis applies.
p.000149: (B) Information for each statistical analysis specified in paragraph (a)(3)(v)(A) of this section
p.000149: must include the following elements:
p.000149: (1) Statistical Analysis Overvie : Iden- tification of the arms or comparison groups compared in
p.000149: the statistical analysis; the type of statistical test conducted; and, for a non-inferiority or
p.000149: equivalence test, a description of the analysis that includes, at minimum, the power calculation and
p.000149: non-inferi- ority or equivalence margin.
p.000149: (2) One of the following, as applica- ble:
p.000149: (i) Statistical Test of Hypothesis: The p- value and the procedure used for the statistical analysis; or
p.000149: (ii) Method of Estimation: The esti- mation parameter, estimated value, and confidence interval
p.000149: (if calculated).
p.000149: (4) Adverse event information. (i) Infor- mation to describe the methods for col- lecting adverse events during
p.000149: an appli- cable clinical trial:
p.000149: (A) Time Frame. The specific period of time over which adverse event infor- mation was collected and for which in-
...
p.000149: any arm of the clinical trial; or
p.000149: (3) Deaths due to any cause.
p.000149: (D) Adverse Event Information. For the two tables described in paragraphs (a)(4)(ii)(A) and (B) of this
p.000149: section, a description of each type of serious ad- verse event and other adverse event that is not a
p.000149: serious adverse event and exceeds a frequency of 5 percent within any arm of the clinical trial, consisting of the
p.000149: following attributes:
p.000149: (1) Descriptive term for the adverse event; and
p.000149: (2) Organ system associated with the adverse event.
p.000149: (E) Adverse Event Data. For the two tables described in paragraphs (a)(4)(ii)(A) and (B) of
p.000149: this section and for each adverse event listed in accord- ance with paragraph (a)(4)(iii)(D) of this section:
p.000149: (1) Number of human subjects af- fected by such adverse event.
p.000150: 150
p.000150:
p.000150:
p.000150:
p.000150:
p.000150:
p.000150:
p.000150:
p.000150: Public Health Service, HHS § 11.48
p.000150:
p.000150:
p.000150: (2) Number of human subjects at risk for such adverse event.
p.000150: (5) Protocol and statistical analysis plan. A copy of the protocol and the statistical analysis
p.000150: plan (if not in- cluded in the protocol), including all amendments that have been approved by a human
p.000150: subjects protection review board (if applicable) before the time of submission under this subsection and
p.000150: that apply to all clinical trial Facility Locations. The responsible party must include the Official Title
p.000150: (as defined in
p.000150: § 11.10(b)(2)), NCT number (as defined in
p.000150: § 11.10(a)) (if available), and date of the protocol and the statistical analysis plan on the cover
p.000150: page of each docu- ment. The responsible party may re- dact names, addresses, and other per- sonally
p.000150: identifiable information, as well as any trade secret and/or con- fidential commercial
p.000150: information (as those terms are defined in the Freedom of Information Act (5 U.S.C. 552) and the Trade
p.000150: Secrets Act (18 U.S.C. 1905)) contained in the protocol or statistical analysis plan prior to submission, un-
p.000150: less such information is otherwise re- quired to be submitted under this part. The protocol and statistical
p.000150: analysis plan must be submitted in a common electronic document format specified at
p.000150: https://prsinfo.clinicaltrials.gov.
p.000150: (6) Administrative information—(i) Re-
p.000150: sults Point of Contact. Point of contact for scientific information about the clinical trial results
p.000150: information, in- cluding the following:
p.000150: (A) Name or official title of the point of contact
p.000150: (B) Name of the affiliated organiza- tion, and
p.000150: (C) Telephone number and email ad- dress of the point of contact.
p.000150: (ii) Certain Agreements. An indication of whether the principal investigator is an employee of the sponsor and, if
p.000150: not, whether there exists any agreement (other than an agreement solely to comply with applicable
p.000150: provisions of law protecting the privacy of human subjects participating in the clinical trial)
p.000150: between the sponsor or its agent and the principal investigator that re- stricts in any manner the ability of
p.000150: the principal investigator, after the pri- mary completion date of the clinical trial, to discuss the
p.000150: results of the clin- ical trial at a scientific meeting or any
p.000150:
p.000150: other public or private forum or to publish in a scientific or academic journal information
p.000150: concerning the re- sults of the clinical trial
p.000150: (7) Additional clinical trial results infor- mation for applicable device clinical trials of unapproved or
p.000150: uncleared device prod- ucts. (i) For an applicable device clin- ical trial of an unapproved or uncleared device
p.000150: product and for which clinical trial registration information has not been posted publicly on
p.000150: Clinical Trials.gov by the Director in accord- ance with § 11.35(b)(2)(i), the responsible party must provide
p.000150: the following data elements, as the data elements are de- fined in § 11.10(b): Brief Title; Official
p.000150: Title; Brief Summary; Primary Pur- pose; Study Design; Study Type; Pri- mary Disease or Condition Being
p.000150: Stud- ied in the Trial, or the Focus of the Study; Intervention Name(s); Other Intervention Name(s);
p.000150: Intervention De- scription; Intervention Type; Device Product Not Approved or Cleared by
p.000150: U.S. FDA, if any studied intervention is a device product; Study Start Date; Primary Completion Date; Study
p.000150: Com- pletion Date, Enrollment; Primary Outcome Measure Information; Sec- ondary Outcome Measure
p.000150: Information; Eligibility Criteria; Sex/Gender; Age Limits; Accepts Healthy Volunteers; Overall
p.000150: Recruitment Status; Why Study Stopped; Name of the Sponsor; Responsible Party, by Official Title;
p.000150: Facility Name and Facility Location, for each participating facility in a clin- ical trial; Unique Protocol
p.000150: Identifica- tion Number; Secondary ID; Human Subjects Protection Review Board Sta- tus; and Record Verification
p.000150: Date.
p.000150: (ii) The responsible party shall sub-
p.000150: mit all the results information speci- fied in paragraph (a)(7)(i) and must sub- mit an affirmation that any
p.000150: informa- tion previously submitted to ClinicalTrials.gov for the data elements listed in
p.000150: paragraph (a)(7)(i) of this sec- tion have been updated in accordance with § 11.64(a) and are to be included
p.000150: as clinical trial results information.
p.000150: (b) Pediatric postmarket surveillance of
p.000150: a device product that is not a clinical trial. For each pediatric postmarket surveillance of a
p.000150: device product that is not a clinical trial, the responsible party must submit a copy of any final
p.000150: report that is submitted to FDA as
p.000151: 151
p.000151:
p.000151:
p.000151:
p.000151:
p.000151:
p.000151:
p.000151:
p.000151:
p.000151: § 11.52
p.000151: specified in 21 CFR 822.38. The respon- sible party may redact names, address- es, and other personally
p.000151: identifiable in- formation or commercial confidential information contained in the final re- port prior to
p.000151: submission to NIH, unless such information is otherwise required to be submitted under this part. The final
p.000151: report must be in a common elec- tronic document format specified at https://prsinfo.clinicaltrials.gov.
p.000151:
p.000151: § 11.52 By when will the NIH Director post submitted clinical trial results information?
p.000151: Except for clinical trial results infor- mation submitted under section 402(j)(4)(A) of the PHS Act
p.000151: and § 11.60, the Director will post publicly clinical trial results information on
p.000151: ClinicalTrials.gov not later than 30 cal- endar days after the date of submis- sion.
p.000151: § 11.54 What are the procedures for re- questing and obtaining a waiver of the requirements for clinical
p.000151: trial results information submission?
p.000151: (a) Waiver request. (1) A responsible party for an applicable clinical trial with a primary
p.000151: completion date on or after January 18, 2017 may request a waiver from any applicable require- ment(s)
p.000151: of this subpart C by submitting a waiver request in the format speci- fied at https://prsinfo.clinicaltrials.gov/
p.000151: to the Secretary or delegate prior to the deadline specified in § 11.44(a) for sub- mitting clinical trial
p.000151: results informa- tion.
p.000151: (2) The waiver request must contain:
p.000151: (i) The NCT number, Brief Title, and Name of the Sponsor of the applicable clinical trial for which the
p.000151: waiver is re- quested;
p.000151: (ii) The specific requirement(s) of this subpart C for which the waiver is requested; and
p.000151: (iii) A description of the extraor- dinary circumstances that the respon- sible party believes justify
p.000151: the waiver and an explanation of why granting the request would be consistent with the protection of public
p.000151: health or in the in- terest of national security.
p.000151: (3) The responsible party will not be required to comply with the specified requirements of this subpart
p.000151: for which a waiver is granted.
p.000151: 42 CFR Ch. I (10–1–16 Edition)
p.000151: (4) The responsible party must com- ply with any requirements of this sub- part for which a waiver is
p.000151: not granted or must submit an appeal as set forth in paragraph (b) of this section. The deadline for
p.000151: submitting any required clinical trial results information will be the later of the original submission
p.000151: deadline or 30 calendar days after the notification of the denial is sent to the responsible party.
p.000151: (b) Appealing a denied aiver request.
p.000151: (1) A responsible party for an applica- ble clinical trial with a primary com- pletion date on or
p.000151: after January 18, 2017 may appeal a denied waiver re- quest by submitting an appeal to the
p.000151: Secretary or delegate in the format specified at https://
p.000151: prsinfo.clinicaltrials.gov/ not later than
p.000151: 30 calendar days after the date on which the electronic notification of the denial in paragraph (a)(4)
p.000151: of this sec- tion denying the request is sent to the responsible party.
p.000151: (2) The responsible party is not re- quired to comply with any require- ments of this subpart for which
p.000151: a waiv- er is granted upon appeal.
p.000151: (3) The responsible party must sub- mit clinical trial results information to comply with any
p.000151: requirements of this subpart that are not waived upon appeal by the later of the original sub- mission
p.000151: deadline or 30 calendar days after the notice of the denial upon ap- peal is sent to the responsible party.
p.000151: (c) If a waiver is granted under para- graph (a) or (b) of this section:
p.000151: (1) The Director will include a nota- tion in the clinical trial record that specified elements of the
p.000151: requirements of this part have been waived.
p.000151: (2) The Secretary will notify, in writ- ing, the appropriate committees of Congress and provide an
p.000151: explanation for why the waiver was granted, not later than 30 calendar days after any waiver is granted.
p.000151: (d) A responsible party for an appli- cable clinical trial with a primary completion date before
p.000151: January 18, 2017 may request a waiver from any applica- ble requirement(s) for clinical trial re- sults
p.000151: information submission by sub- mitting a waiver request, as specified in section 402(j)(3)(H) of the
p.000151: Public Health Service Act (42 U.S.C. 282(j)(3)(H)).
p.000152: 152
p.000152:
p.000152:
p.000152:
p.000152:
p.000152:
p.000152:
p.000152:
p.000152: Public Health Service, HHS § 11.60
p.000152:
p.000152: Subpart D—Additional Submission of Clinical Trial Information
p.000152: § 11.60 What requirements apply to the voluntary submission of clinical trial information for clinical
p.000152: trials of FDA-regulated drug products (in- cluding biological products) and de- vice products?
p.000152: (a) If a responsible party voluntarily submits clinical trial information for a clinical trial described in
p.000152: paragraph (a)(1) of this section, the responsible party must meet the conditions speci- fied in paragraph
p.000152: (a)(2) of this section.
p.000152: (1) The requirements of paragraph (a) of this section apply to a clinical trial that was initiated before
p.000152: January 18, 2017 and has a primary completion date before January 18, 2017, and that is ei- ther:
p.000152: (i) A clinical trial of an FDA-regu- lated drug product (including a biologi- cal product) or device product
p.000152: that is not an applicable clinical trial, or
p.000152: (ii) An applicable clinical trial that is not otherwise required to submit clinical trial registration
p.000152: information.
p.000152: (2) If the responsible party for a clin- ical trial described in paragraph (a)(1) of this section
p.000152: voluntarily submits clinical trial registration information and/or clinical trial results informa- tion,
p.000152: the responsible party must com- ply with the following requirements:
p.000152: (i) The responsible party must sub- mit the information in paragraphs (b)(2)(i)(A), (B), or (C) of
p.000152: this section for the clinical trial being submitted voluntarily.
p.000152: (A) If the responsible party volun- tarily registers a clinical trial, the re- sponsible party must
p.000152: submit clinical trial registration information specified in section 402(j)(2)(A)(ii) of the Public Health
p.000152: Service Act (42 U.S.C. 282(j)(2)(A)(ii)).
p.000152: (B) If the responsible party volun- tarily submits clinical trial results in- formation for a
p.000152: clinical trial for which the clinical trial registration informa- tion specified in section 402(j)(2)(A)(ii)
p.000152: of the Public Health Service Act (42
p.000152: U.S.C. 282(j)(2)(A)(ii)) has not been sub- mitted, the responsible party must sub- mit the clinical trial results
p.000152: informa- tion specified in sections 402(j)(3)(C) and 402(j)(3)(I) of the Public Health
p.000152:
p.000152: Service Act (42 U.S.C. 282(j)(3)(C) and 42
p.000152: U.S.C. 282(j)(3)(I)).
p.000152: (C) If the responsible party both vol- untarily submits clinical trial registra- tion information and
p.000152: voluntarily sub- mits clinical trial results information, the responsible party must submit both clinical trial
p.000152: registration information specified in section 402(j)(2)(A)(ii) of the Public Health Service Act
p.000152: (42
p.000152: U.S.C. 282(j)(2)(A)(ii)) and clinical trial results information specified in sec- tions 402(j)(3)(C) and
p.000152: 402(j)(3)(I) of the Public Health Service Act (42 U.S.C. 282(j)(3)(C) and 42 U.S.C. 282(j)(3)(I)).
p.000152: (ii) If, on or after September 27, 2007, a manufacturer submits an application or premarket notification to
p.000152: FDA for approval, licensure, or clearance of a drug product (including a biological product) or device
p.000152: product under sec- tions 505, 510(k), 515, or 520(m) of the Federal Food, Drug, and Cosmetic Act (21
p.000152: U.S.C 355, 360(k), 360e, 360j(m)) or section 351 of the Public Health Service Act (42 U.S.C. 262) for the use
p.000152: studied in the clinical trial submitted under para- graph (a)(1) of this section, the respon- sible party specified in
p.000152: paragraph (a)(1) of this section must also submit the in- formation specified in paragraph (a)(2)(iii)
p.000152: of this section by the deadline specified in paragraph (a)(2)(iv)(B) of this section for any applicable
p.000152: clinical trial that has not been submitted to ClinicalTrials.gov and that meets the following criteria:
p.000152: (A) The applicable clinical trial is re- quired to be submitted to FDA under sections 505, 510(k), 515, or 520(m)
p.000152: of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355, 360(k), 360e, 360j(m)) or section 351 of the
p.000152: Public Health Service Act (42 U.S.C. 262) in an application or premarket notification for approval, li- censure,
p.000152: or clearance to market the drug product (including a biological product) or device product for
p.000152: the use studied in the clinical trial specified in paragraph (a)(1) of this section; and
p.000152: (B) The manufacturer of the drug product (including a biological prod- uct) or device product
p.000152: studied in the applicable clinical trial is also the re- sponsible party for the clinical trial
p.000152: specified in paragraph (a)(1) of this sec- tion.
p.000153: 153
p.000153:
p.000153:
p.000153:
p.000153:
p.000153:
p.000153:
p.000153:
p.000153:
p.000153: § 11.60
p.000153: (iii) Information to be submitted for clinical trials described in paragraph (a)(2)(ii) of this section:
p.000153: (A) If the clinical trial information voluntarily submitted for a clinical trial described in
p.000153: paragraph (a)(1) of this section consists only of the clin- ical trial registration information
p.000153: specified in section 402(j)(2)(A)(ii) of the Public Health Service Act (42
p.000153: U.S.C. 282(j)(2)(A)(ii)), the information to be submitted in accordance with paragraph (a)(2)(ii) of this
p.000153: section must consist, at minimum, of the clinical trial registration information specified in section
p.000153: 402(j)(2)(A)(ii) of the Public Health Service Act (42 U.S.C. 282(j)(2)(A)(ii)).
p.000153: (B) If the clinical trial information voluntarily submitted for a clinical trial described by paragraph
p.000153: (a)(1) of this section consists of the clinical trial results information specified in sections
p.000153: 402(j)(3)(C) and 402(j)(3)(I) of the Public Health Service Act (42
p.000153: U.S.C. 282(j)(3)(C) and 42 U.S.C. 282(j)(3)(I)), the information to be sub- mitted in accordance
p.000153: with paragraph (a)(2)(ii) of this section must consist of the clinical trial results information specified
p.000153: in sections 402(j)(3)(C) and 402(j)(3)(I) of the Public Health Service Act (42 U.S.C. 282(j)(3)(C) and
p.000153: 42 U.S.C. 282(j)(3)(I)).
...
p.000153: submitted for the primary outcome measure(s) or 1 year after the date of final collection of data
p.000153: for adverse event information, whether the clinical trial was con- cluded according to the
p.000153: pre-specified protocol or was terminated.
p.000153: (B) The clinical trial information
p.000153: specified in paragraph (a)(2)(iii) of this section must be submitted not later than the later of the
p.000153: date on which the application or premarket notification to FDA for approval, licensure, or clearance to
p.000153: market a drug product (in- cluding a biological product) or device product under section 351 of the Public Health
p.000153: Service Act (42 U.S.C. 262) or section 505, 510(k), 515, or 520(m) of the Federal Food, Drug, and
p.000153: Cosmetic Act (21 U.S.C. 355, 360(k), 360e, 360j(m)) for
p.000153: the use studied in the clinical trial specified under paragraph (a)(1) of this
p.000154: 154
p.000154:
p.000154:
p.000154:
p.000154:
p.000154:
p.000154:
p.000154:
p.000154: Public Health Service, HHS § 11.60
p.000154:
p.000154:
p.000154: section is submitted to FDA or the date on which the clinical trial infor- mation specified in
p.000154: paragraph (a)(2)(i) of this section for the clinical trial specified under paragraph (a)(1) of this
p.000154: section is submitted to ClinicalTrials.gov.
p.000154: (b) If a responsible party voluntarily submits clinical trial information for a clinical trial described in
p.000154: paragraph (b)(1) of this section, the responsible party must meet the conditions speci- fied in paragraph
p.000154: (b)(2) of this section.
p.000154: (1) The requirements of paragraph (b) of this section apply to a clinical trial that was initiated before
p.000154: January 18, 2017 and has a primary completion date on or after January 18, 2017, and that is either:
p.000154: (i) A clinical trial of an FDA-regu- lated drug product (including a biologi- cal product) or device product
p.000154: that is not an applicable clinical trial; or
p.000154: (ii) An applicable clinical trial that is not otherwise required to submit clinical trial registration
p.000154: information.
p.000154: (2) If the responsible party for a clin- ical trial described in paragraph (b)(1) of this section
p.000154: voluntarily submits clinical trial registration information and/or clinical trial results informa- tion,
p.000154: the responsible party must com- ply with the following requirements:
p.000154: (i) The responsible party must sub- mit the information in paragraph (b)(2)(i)(A), (B), or (C) of
p.000154: this section for the clinical trial being submitted voluntarily.
p.000154: (A) If the responsible party volun- tarily registers a clinical trial, the re- sponsible party must
p.000154: submit clinical trial registration information specified in section 402(j)(2)(A)(ii) of the Public Health
p.000154: Service Act (42 U.S.C. 282(j)(2)(A)(ii)).
p.000154: (B) If the responsible party volun- tarily submits clinical trial results in- formation for a
p.000154: clinical trial for which the clinical trial registration informa- tion specified in section 402(j)(2)(A)(ii)
p.000154: of the Public Health Service Act (42
p.000154: U.S.C. 282(j)(2)(A)(ii)) has not been sub- mitted, the responsible party must sub- mit the data elements
p.000154: specified in
p.000154: § 11.48, as well as the data elements listed below, as those data elements are defined in §
p.000154: 11.10(b) and apply to the clinical trial and the intervention(s) studied: Brief Title; Official Title; Brief
p.000154:
p.000154: Summary; Primary Purpose; Study De- sign; Study Phase, for a clinical trial of a drug product (including a
p.000154: biological product); Study Type; Pediatric Postmarket Surveillance of a Device Product; Primary
p.000154: Disease or Condition Being Studied in the Trial, or the Focus of the Study; Intervention
p.000154: Name(s), for each intervention studied; Other Intervention Name(s), for each intervention studied; Intervention
p.000154: De- scription, for each intervention stud- ied; Intervention Type, for each inter- vention studied; Device
p.000154: Product Not Approved or Cleared by U.S. FDA, if any studied intervention is a device product;
p.000154: Product Manufactured in and Exported from the U.S.; Studies a U.S. FDA-regulated Device Product; Studies a
p.000154: U.S. FDA-regulated Drug Product; Study Start Date; Primary Completion Date; Study Completion Date; Enroll-
p.000154: ment; Eligibility Criteria; Sex/Gender; Age Limits; Accepts Healthy Volun- teers; Overall Recruitment
p.000154: Status; Why Study Stopped; Availability of Ex- panded Access, if any studied interven- tion is an investigational
p.000154: drug product (including a biological product); Name of the Sponsor; Responsible Party, by Official Title;
p.000154: Facility Information, for each participating facility; Unique Protocol Identification Number; Sec-
p.000154: ondary ID; U.S. Food and Drug Admin- istration IND or IDE Number; Human Subjects Protection Review Board Sta- tus;
p.000154: Record Verification Date; and Re- sponsible Party Contact Information.
p.000154: (C) If the responsible party both vol-
p.000154: untarily submits clinical trial registra- tion information and voluntarily sub- mits clinical trial results
p.000154: information, the responsible party must submit both the clinical trial registration informa- tion specified in
p.000154: section 402(j)(2)(A)(ii) of the Public Health Service Act (42
p.000154: U.S.C. 282(j)(2)(A)(ii)) and the clinical trial results information specified in
p.000154: § 11.48.
p.000154: (ii) If, on or after September 27, 2007, a manufacturer submits an application or premarket notification to
p.000154: FDA for approval, licensure, or clearance of a drug product (including a biological product) or device
p.000154: product under sec- tion 505, 510(k), 515, or 520(m) of the Federal Food, Drug, and Cosmetic Act (21
p.000154: U.S.C. 355, 360(k), 360e, 360j(m)) or section 351 of the Public Health Service
p.000155: 155
p.000155:
p.000155:
p.000155:
p.000155:
p.000155:
p.000155:
p.000155:
p.000155:
p.000155: § 11.60
p.000155: Act (42 U.S.C. 262) for the use studied in the clinical trial submitted under para- graph (b)(1) of this section, the
p.000155: respon- sible party specified in paragraph (b)(1) of this section must also submit the in- formation specified
p.000155: in paragraph (b)(2)(iii) of this section by the deadline specified in paragraph (b)(2)(iv)(B) of this
p.000155: section for any applicable clinical trial that has not been submitted to ClinicalTrials.gov and that
p.000155: meets the following criteria:
p.000155: (A) The applicable clinical trial is re- quired to be submitted to FDA under section 505, 510(k), 515, or
p.000155: 520(m) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355, 360(k), 360e, 360j(m)) or section 351
p.000155: of the Public Health Service Act (42 U.S.C. 262) in an application or premarket notification for approval, li-
p.000155: censure, or clearance to market the drug product (including a biological product) or device
p.000155: product for the use studied in the clinical trial specified in paragraph (b)(1) of this section; and
p.000155: (B) The manufacturer of the drug product (including a biological prod- uct) or device product
p.000155: studied in the applicable clinical trial is also the re- sponsible party for the clinical trial
p.000155: specified in paragraph (b)(1) of this sec- tion.
p.000155: (iii) Information to be submitted for clinical trials described in paragraph (b)(2)(ii) of this section:
p.000155: (A) If the clinical trial information voluntarily submitted for a clinical trial described in
p.000155: paragraph (b)(1) of this section consists only of the clin- ical trial registration information
p.000155: specified in section 402(j)(2)(A)(ii) of the Public Health Service Act (42
p.000155: U.S.C. 282(j)(2)(A)(ii)), the information to be submitted in accordance with paragraph (b)(2)(ii) of this
p.000155: section must consist, at minimum, of the clinical trial registration information specified in section
p.000155: 402(j)(2)(A)(ii) of the Public Health Service Act (42 U.S.C. 282(j)(2)(A)(ii)).
p.000155: (B) If the clinical trial information voluntarily submitted for a clinical trial described by paragraph
p.000155: (b)(1) of this section consists of the clinical trial results information specified in
p.000155: § 11.60(b)(2)(i)(B), the information to be submitted in accordance with para- graph (b)(2)(ii) of
p.000155: this section must
p.000155: 42 CFR Ch. I (10–1–16 Edition)
p.000155: consist of the clinical trial results in- formation specified in § 11.60(b)(2)(i)(B).
p.000155: (C) If the clinical trial information voluntarily submitted for a clinical trial described by paragraph
p.000155: (b)(1) of this section consists of both the clin- ical trial registration information specified
p.000155: in section 402(j)(2)(A)(ii) of the Public Health Service Act (42
p.000155: U.S.C. 282(j)(2)(A)(ii)) and the clinical trial results information specified in
...
p.000155: § 11.48(a)(4) must be submitted by the later of the date that the clinical trial results information is
p.000155: voluntarily sub- mitted for the primary outcome meas- ure(s) or 1 year after the date of final collection
p.000155: of data for adverse event in- formation, whether the clinical trial
p.000156: 156
p.000156:
p.000156:
p.000156:
p.000156:
p.000156:
p.000156:
p.000156:
p.000156: Public Health Service, HHS § 11.60
p.000156:
p.000156:
p.000156: was concluded according to the pre- specified protocol or was terminated.
p.000156: (B) The clinical trial information specified in paragraph (b)(2)(iii) of this section must be
p.000156: submitted not later than the later of the date on which the application or premarket notification to FDA for
p.000156: approval, licensure, or clearance to market a drug product (in- cluding a biological product) or device
p.000156: product under section 351 of the Public Health Service Act (42 U.S.C. 262) or section 505, 510(k), 515, or
p.000156: 520(m) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355, 360(k), 360e, 360j(m)) for the use
p.000156: studied in the clinical trial specified under paragraph (b)(1) of this section is submitted to FDA
p.000156: or the date on which the clinical trial infor- mation specified in paragraph (b)(2)(i) of this
p.000156: section for the clinical trial specified under paragraph (b)(1) of this section is
p.000156: submitted to ClinicalTrials.gov.
p.000156: (c) If a responsible party voluntarily submits clinical trial information for a clinical trial described in
p.000156: paragraph (c)(1) of this section, the responsible party must meet the conditions speci- fied in
p.000156: paragraph (c)(2) of this section.
p.000156: (1) The requirements of paragraph (c) of this section apply to a clinical trial that was initiated on or
p.000156: after January 18, 2017 and has a primary completion date on or after January 18, 2017, and that is
p.000156: either:
p.000156: (i) A clinical trial of an FDA-regu- lated drug product (including a biologi- cal product) or device product
p.000156: that is not an applicable clinical trial; or
p.000156: (ii) An applicable clinical trial that is not otherwise required to submit clinical trial registration
p.000156: information.
p.000156: (2) If the responsible party for a clin- ical trial described in paragraph (c)(1) of this section
p.000156: voluntarily submits clinical trial registration information and/or clinical trial results informa- tion,
p.000156: the responsible party must com- ply with the following requirements:
p.000156: (i) The responsible party must sub- mit the information in paragraph (c)(2)(i)(A), (B), or (C) of
p.000156: this section for the clinical trial being submitted voluntarily.
p.000156: (A) If the responsible party volun- tarily registers a clinical trial, the re- sponsible party must
p.000156: submit the clin-
p.000156:
p.000156: ical trial registration information specified in § 11.28(a).
p.000156: (B) If the responsible party volun- tarily submits clinical trial results in- formation for a
p.000156: clinical trial for which the clinical trial registration informa- tion specified in § 11.28(a) has not
p.000156: been submitted, the responsible party must submit the data elements specified in paragraph (b)(2)(i)(B) of
p.000156: this section.
p.000156: (C) If the responsible party both vol- untarily submits clinical trial registra- tion information and
p.000156: voluntarily sub- mits clinical trial results information, the responsible party must submit both the clinical
p.000156: trial registration informa- tion specified in § 11.28(a) and the clin- ical trial results information
p.000156: specified in § 11.48.
p.000156: (ii) If, on or after September 27, 2007, a manufacturer submits an application or premarket notification to
p.000156: FDA for approval, licensure, or clearance of a drug product (including a biological product) or device
p.000156: product under sec- tion 505, 510(k), 515, or 520(m) of the Federal Food, Drug, and Cosmetic Act (21
p.000156: U.S.C. 355, 360(k), 360e, 360j(m)) or section 351 of the Public Health Service Act (42 U.S.C. 262) for the use
p.000156: studied in the clinical trial submitted under para- graph (c)(1) of this section, the respon- sible party
p.000156: specified in paragraph (c)(1) of this section must also submit the in- formation specified in paragraph
p.000156: (c)(2)(iii) of this section by the deadline specified in paragraph (c)(2)(iv)(B) of this section for any
p.000156: applicable clinical trial that has not been submitted to ClinicalTrials.gov and that meets the following
p.000156: criteria:
p.000156: (A) The applicable clinical trial is re-
p.000156: quired to be submitted to FDA under section 505, 510(k), 515, or 520(m) of the Federal Food, Drug, and
p.000156: Cosmetic Act (21 U.S.C. 355, 360(k), 360e, 360j(m)) or
p.000156: section 351 of the Public Health Service Act (42 U.S.C. 262) in an application or premarket notification for
p.000156: approval, li- censure, or clearance to market the drug product (including a biological product) or
p.000156: device product for the use studied in the clinical trial specified in paragraph (c)(1) of this section; and
p.000156: (B) The manufacturer of the drug product (including a biological prod- uct) or device product
p.000156: studied in the applicable clinical trial is also the re- sponsible party for the clinical trial
p.000157: 157
p.000157:
p.000157:
p.000157:
p.000157:
p.000157:
p.000157:
p.000157:
p.000157:
p.000157: § 11.60
p.000157: specified in paragraph (c)(1) of this sec- tion.
p.000157: (iii) Information to be submitted for clinical trials described in paragraph (c)(2)(ii) of this section:
p.000157: (A) If the clinical trial information voluntarily submitted for a clinical trial described in
p.000157: paragraph (c)(1) of this section consists only of the clin- ical trial registration information
p.000157: specified in § 11.28(a), the information to be submitted in accordance with paragraph (c)(2)(ii) of this
p.000157: section must consist, at minimum, of the clinical trial registration information specified in § 11.28(a).
p.000157: (B) If the clinical trial information voluntarily submitted for a clinical trial described by paragraph
p.000157: (c)(1) of this section consists of the clinical trial results information specified in
p.000157: § 11.60(c)(2)(i)(B), the information to be submitted in accordance with para- graph (c)(2)(ii) of
p.000157: this section must consist of the clinical trial results in- formation specified in § 11.60(c)(2)(i)(B).
p.000157: (C) If the clinical trial information voluntarily submitted for a clinical trial described by paragraph
p.000157: (c)(1) of this section consists of both the clin- ical trial registration information specified in
p.000157: § 11.28(a) and the clinical trial results information specified in
p.000157: § 11.48, the information to be submitted in accordance with paragraph (c)(2)(ii) of this section must consist of
p.000157: both the clinical trial registration information specified in § 11.28(a) and the clinical trial results
...
p.000157: submitted to ClinicalTrials.gov.
p.000157: (v) All submissions of clinical trial
p.000157: information under paragraph (c) of this section are subject to the applicable update and corrections
p.000157: requirements specified in § 11.64.
p.000157: (d) Statement to accompany applica- ble clinical trials submitted under paragraphs (a), (b), and
p.000157: (c) of this sec- tion. Each applicable clinical trial for which clinical trial information is sub- mitted
p.000157: under paragraphs (a), (b), and
p.000157: (c) of this section and posted on ClinicalTrials.gov will include the state- ment ‘‘This clinical
p.000157: trial information was submitted voluntarily under the
p.000158: 158
p.000158:
p.000158:
p.000158:
p.000158:
p.000158:
p.000158:
p.000158:
p.000158: Public Health Service, HHS § 11.64
p.000158:
p.000158:
p.000158: applicable law and, therefore, certain submission deadlines may not apply. (That is, clinical trial
p.000158: information for this applicable clinical trial was sub- mitted under section 402(j)(4)(A) of the Public
p.000158: Health Service Act and 42 CFR
p.000158: 11.60 and is not subject to the deadlines established by sections 402(j)(2) and (3) of the Public Health
p.000158: Service Act or 42 CFR 11.24 and 11.44.)’’
p.000158: § 11.62 What requirements apply to ap- plicable clinical trials for which submission of clinical trial
p.000158: informa- tion has been determined by the Di- rector to be necessary to protect the public health?
p.000158: (a) A responsible party who receives notification that the Director has de- termined that posting of
p.000158: clinical trial information for an applicable clinical trial described in paragraph (b) of this section is
p.000158: necessary to protect the pub- lic health must submit clinical trial in- formation as specified in paragraph (c) of
p.000158: this section.
p.000158: (b) An applicable clinical trial sub- ject to this section must be either:
p.000158: (1) An applicable clinical trial of an approved, licensed, or cleared drug product (including a
p.000158: biological prod- uct) or device product that has a pri- mary completion date on or after Sep- tember 27,
p.000158: 1997; or
p.000158: (2) An applicable clinical trial that is subject to registration under § 11.22(a) and studies a drug product
p.000158: (including a biological product) or device product that is unapproved, unlicensed, or uncleared,
p.000158: regardless of whether ap- proval, licensure, or clearance was, is, or will be sought, and that is not other-
p.000158: wise subject to results information submission in accordance with the reg- ulation.
p.000158: (c) Deadline for submission of clin- ical trial information:
p.000158: (1) General. Except as provided in paragraphs (c)(2) and (c)(3) of this sec- tion, a responsible party
p.000158: for an applica- ble clinical trial that is subject to this section must submit the clinical trial registration
p.000158: information specified in
p.000158: § 11.28(a) and the clinical trial results information specified in § 11.48(a) not later than 30
p.000158: calendar days after the submission date specified in the notifi- cation described in paragraph (a) of this
p.000158: section.
p.000158:
p.000158: (2) Exception. If a responsible party submits a certification consistent with
p.000158: § 11.44(b) or (c) not later than 30 cal- endar days after the submission date specified in the
p.000158: notification described in paragraph (a) of this section, the re- sponsible party must submit the clin- ical
p.000158: trial results information specified in § 11.48(a) not later than the deadline specified in § 11.44(b) or
p.000158: (c), as applica- ble.
p.000158: (3) If a responsible party submitted clinical trial registration information describing the applicable
p.000158: clinical trial specified in the notification described in paragraph (a) of this section prior to the date on
p.000158: which the notification is sent to the responsible party, the re- sponsible party must update such clin-
p.000158: ical trial information to reflect changes, if any, in the applicable clin- ical trial not
p.000158: later than 30 calendar days after the submission date speci- fied in the notification described in
p.000158: paragraph (a) of this section, irrespec- tive of the deadline for updates speci- fied in § 11.64.
p.000158: § 11.64 When must clinical trial infor- mation submitted to ClinicalTrials.gov
p.000158: be updated or corrected?
p.000158: (a) Updates. (1) Clinical trial registra- tion information:
p.000158: (i) The responsible party for an appli- cable clinical trial for which clinical trial registration information
p.000158: was re- quired to be submitted if the clinical trial was initiated before January 18, 2017, must submit
p.000158: updates in accord- ance with the following:
p.000158: (A) In general, changes to the clinical trial registration information specified in section 402(j)(2)(A)(ii) of the
p.000158: Public Health Service Act (42 U.S.C. 282(j)(2)(A)(ii)) that was required at the time of
p.000158: submission must be updated not less than once every 12 months.
p.000158: (B) Overall Recruitment Status must be updated not later than 30 calendar days after any change in
p.000158: overall re- cruitment status.
p.000158: (C) Primary Completion Date must be updated not later than 30 calendar days after the clinical trial
p.000158: reaches its actual primary completion date.
p.000158: (ii) The responsible party for an ap- plicable clinical trial, or for another
p.000159: 159
p.000159:
p.000159:
p.000159:
p.000159:
p.000159:
p.000159:
p.000159:
p.000159:
p.000159: § 11.64
p.000159: clinical trial for which registration in- formation was voluntarily submitted pursuant to § 11.60(c),
p.000159: if the clinical trial was initiated on or after January 18, 2017, must submit updates in ac-
p.000159: cordance with the following:
p.000159: (A) In general, changes to clinical trial registration information specified in § 11.28 must be updated not
p.000159: less than once every 12 months.
p.000159: (B) If the first human subject was not enrolled in the clinical trial at the time of registration, the
p.000159: Study Start Date data element must be updated not later than 30 calendar days after the first human subject is
p.000159: enrolled.
p.000159: (C) Intervention Name(s) must be up- dated to a non-proprietary name not later than 30 calendar days after a non-
p.000159: proprietary name is established for any intervention included in the Interven- tion Name(s) data element.
p.000159: (D) Availability of expanded access:
p.000159: (1) If expanded access to an investiga- tional drug product (including a bio- logical product) becomes
p.000159: available after an applicable clinical trial of that product has been registered, the re- sponsible party,
p.000159: if both the manufac- turer of the investigational drug prod- uct (including a biological product) and the
p.000159: sponsor of the applicable clinical trial, must, not later than 30 calendar days after expanded access
p.000159: becomes available, update the Availability of Expanded Access data element for that applicable clinical trial
p.000159: and, unless an expanded access record has already been created as required by
p.000159: § 11.28(a)(2)(ii)(H), submit the data ele-
p.000159: ments in accordance with § 11.28(c) to create an expanded access record.
p.000159: (2) No later than 30 calendar days after the date on which the responsible party receives an NCT number
p.000159: for an expanded access record created as re- quired by § 11.28(a)(2)(ii)(H), the respon- sible party must
p.000159: update the Avail- ability of Expanded Access data ele- ment by entering the NCT number in the
p.000159: clinical trial record for the applica- ble clinical trial.
p.000159: (E) Expanded access record:
p.000159: (1) Expanded Access Status, under
p.000159: § 11.28(c)(2)(iv), must be updated not later than 30 calendar days after a change in the
p.000159: availability of expanded access to an investigational drug prod- uct (including a biological product)
p.000159: 42 CFR Ch. I (10–1–16 Edition)
p.000159: under section 561 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360bbb).
p.000159: (2) Expanded Access Type, under
p.000159: § 11.28(c)(1)(x), must be updated not later than 30 calendar days after a change in the type(s)
p.000159: of expanded ac- cess available for an investigational drug product (including a biological product)
p.000159: under section 561 of the Fed- eral Food, Drug, and Cosmetic Act (21
p.000159: U.S.C. 360bbb).
p.000159: (F) Overall Recruitment Status must be updated not later than 30 calendar days after any change in
p.000159: overall re- cruitment status. If, at any time, Over- all Recruitment Status is changed to ‘‘suspended,’’
p.000159: ‘‘terminated,’’ or ‘‘with- drawn,’’ the responsible party must also submit the Why Study Stopped
p.000159: data element.
p.000159: (G) Individual Site Status must be updated not later than 30 calendar days after a change in status for any
p.000159: indi- vidual site.
p.000159: (H) Human Subjects Protection Re- view Board Status must be updated not later than 30 calendar days after
p.000159: a change in status.
p.000159: (I) Primary Completion Date must be updated not later than 30 calendar days after the clinical trial reaches its
p.000159: ac- tual primary completion date. At the time, the date is changed to ‘‘actual,’’ and the Enrollment
p.000159: data element specifying the actual number of par- ticipants enrolled must be submitted.
p.000159: (J) Study Completion Date must be updated not later than 30 calendar days after the clinical trial reaches
p.000159: its ac- tual study completion date.
p.000159: (K) Responsible Party, by Official Title must be updated not later than 30 calendar days after a change in
p.000159: the re- sponsible party or the official title of the responsible party.
p.000159: (L) Responsible Party Contact Infor- mation must be updated not later than 30 calendar days after a change in
p.000159: the responsible party or the contact infor- mation for the responsible party.
p.000159: (M) Device Product Not Approved or Cleared by U.S. FDA must be updated not later than 15 calendar days
p.000159: after a change in approval or clearance status has occurred.
p.000159: (N) Record Verification Date must be updated any time the responsible party reviews the complete set of submitted
p.000160: 160
p.000160:
p.000160:
p.000160:
p.000160:
p.000160:
p.000160:
p.000160:
p.000160: Public Health Service, HHS § 11.64
p.000160:
p.000160:
p.000160: clinical trial information for accuracy and not less than every 12 months, even if no other updated information is
p.000160: sub- mitted at that time.
p.000160: (O) If a protocol is amended in such a manner that changes are commu- nicated to human subjects in the
p.000160: clin- ical trial, updates to any relevant clin- ical trial registration information data elements must be submitted
p.000160: not later than 30 calendar days after the pro- tocol amendment is approved by a human
p.000160: subjects protection review board.
p.000160: (iii) In addition to the update re- quirements established in paragraphs (a)(1)(i) and (a)(1)(ii)
p.000160: of this section, clinical trial registration information must be updated at the time that clin- ical
p.000160: trial results information for that clinical trial is initially submitted.
p.000160: (A) If the clinical trial was initiated before January 18, 2017, a responsible party must submit updates to
p.000160: the clin- ical trial registration information de- scribed in § 11.64(a)(1)(i).
p.000160: (B) If the clinical trial was initiated on or after January 18, 2017, the respon- sible party must submit updates
p.000160: to the clinical trial registration information in accordance with § 11.64(a)(1)(ii).
p.000160: (2) Clinical trial results information. The responsible party for an applicable clinical trial, or for
p.000160: another clinical trial for which results information was voluntarily submitted pursuant to
p.000160: § 11.60(b) or (c), where the clinical trial has a Primary Completion Date on or after January 18, 2017,
p.000160: must submit up- dates in accordance with the following:
p.000160: (i) In general, changes to required clinical trial results information, other than the protocol and
p.000160: statistical anal- ysis plan specified in § 11.48(a)(5) and certain agreements specified in
p.000160: § 11.48(a)(6)(ii),must be updated not less than once every 12 months.
p.000160: (ii) For applicable device clinical trials of unapproved or uncleared de- vice products, the
p.000160: responsible party must update the following data ele- ments, as defined in § 11.10(b), in ac-
p.000160: cordance with the following:
p.000160: (A) Intervention Name(s) must be up- dated to a non-proprietary name not later than 30 calendar days after a non-
p.000160: proprietary name is established for any intervention included in the Interven- tion Name(s) data element.
p.000160:
p.000160: (B) Primary Completion Date must be updated not later than 30 calendar days after the clinical trial
p.000160: reaches its actual primary completion date. At the time the date is changed to ‘‘actual,’’ the Enrollment
p.000160: data element speci- fying the actual number of participants enrolled must be submitted.
p.000160: (C) Study Completion Date must be updated not later than 30 calendar days after the clinical trial reaches
p.000160: its ac- tual study completion date.
p.000160: (D) Overall Recruitment Status must be updated not later than 30 calendar days after any change in
p.000160: overall re- cruitment status. If, at any time, Over- all Recruitment Status is changed to ‘‘suspended,’’
p.000160: ‘‘terminated,’’ or ‘‘with- drawn,’’ the responsible party must also submit the Why Study Stopped
p.000160: data element.
p.000160: (E) Record Verification Date must be updated any time the responsible party reviews the complete set of submitted
p.000160: clinical trial information for accuracy and not less than every 12 months, even if no other updated information is
p.000160: sub- mitted at that time.
p.000160: (3) A responsible party’s obligation to submit updates as specified in this sec- tion ends on the date on which
p.000160: all re- quired clinical trial results informa- tion has been submitted as specified in sections 402(j)(3)(C)
p.000160: and 402(j)(3)(I) of the Public Health Service Act (42
p.000160: U.S.C. 282(j)(3)(C)) and 42 U.S.C. 282(j)(3)(I)) or as specified in § 11.48, as applicable, and
p.000160: corrections have been made or addressed in response to any electronic notice received under
p.000160: § 11.64(b)(1). If no clinical trial results information is required to be sub- mitted, a responsible
p.000160: party’s obligation to submit updates to clinical trial reg- istration information ends on the date on which
p.000160: all required clinical trial reg- istration information has been sub- mitted as specified in
p.000160: section 402(j)(2)(A)(ii) of the Public Health Service Act (42 U.S.C. 282(j)(2)(A)(ii) or
p.000160: § 11.28, as applicable, and corrections have been made or addressed in re- sponse to any
p.000160: electronic notice re- ceived under § 11.64(b)(1).
p.000160: (4) Public availability of updates. (i) Updates to clinical trial registration information and
p.000160: clinical trial results
p.000161: 161
p.000161:
p.000161:
p.000161:
p.000161:
p.000161:
p.000161:
p.000161:
p.000161:
p.000161: § 11.66
p.000161: information will be posted in accord- ance with § 11.35 and § 11.52, respec- tively.
p.000161: (ii) The Director will retain prior clinical trial registration information and clinical trial results
p.000161: information and make it publicly available in ac- cordance with § 11.35 and § 11.52, respec- tively, through
p.000161: ClinicalTrials.gov so that updates do not result in the re- moval of any information from the
p.000161: original submission or any preceding update.
p.000161: (b) Corrections—(1) Quality control. After clinical trial registration infor- mation has been submitted as
p.000161: specified in section 402(j)(2)(A)(ii) of the Public Health Service Act (42 U.S.C.
p.000161: 282(j)(2)(A)(ii)) or § 11.28, as applicable, or clinical trial results information has been submitted as
p.000161: specified in sections 402(j)(3)(C) and 402(j)(3)(I) of the Public Health Service Act (42
p.000161: U.S.C. 282(j)(3)(C) and 42 U.S.C. 282(j)(3)(I)) or
p.000161: § 11.48, as applicable, including the up- dates specified in paragraph (a) of this section, the Director may
p.000161: provide elec- tronic notification to the responsible party of apparent errors, deficiencies, and/or
p.000161: inconsistencies in the submitted information identified during proce- dures for quality control review
p.000161: estab- lished by the Director, as specified at https://prsinfo.clinicaltrials.gov. The re- sponsible party
p.000161: must correct or address all apparent errors, deficiencies, and/or inconsistencies identified in the notifi- cation
p.000161: not later than 15 calendar days for clinical trial registration informa- tion, or 25 calendar days for
p.000161: clinical trial results information, after the date of the electronic notification sent to the responsible party.
p.000161: (2) Other corrections. (i) A responsible
p.000161: party who becomes aware of errors, other than those specified in paragraph (b)(1) of this section, in
p.000161: any clinical trial information submitted under this part shall have not more than 15 cal- endar days for
p.000161: clinical trial registra- tion information, or 25 calendar days for clinical trial results information, to
p.000161: correct or address such errors.
p.000161: (ii) A responsible party’s obligation to correct or address errors as specified in paragraph (b)(2) of this
p.000161: section ends on the date on which all required clin- ical trial results information has been submitted
p.000161: as specified in sections
p.000161: 42 CFR Ch. I (10–1–16 Edition)
p.000161: 402(j)(3)(C) and 402(j)(3)(I) of the Public Health Service Act (42 U.S.C. 282(j)(3)(C) and
p.000161: 42 U.S.C. 282(j)(3)(I)) or
p.000161: § 11.48, as applicable, and corrections have been made or addressed in re- sponse to any
p.000161: electronic notice re- ceived under § 11.64(b)(1). If no clinical trial results information is required to
p.000161: be submitted, a responsible party’s ob- ligation to correct or address errors ends on the date on
p.000161: which all required clinical trial registration information has been submitted as specified in sec- tion
p.000161: 402(j)(2)(A)(ii) of the Public Health Service Act (42 U.S.C. 282(j)(2)(A)(ii)) or
p.000161: § 11.28, as applicable, and corrections
p.000161: have been made or addressed in re- sponse to any electronic notice re- ceived under §
p.000161: 11.64(b)(1).
p.000161: (3) Compliance with the quality con- trol review process, including the re- quirements of this section,
p.000161: does not constitute a legal defense to enforce- ment pursuant to section 301(jj) of the Federal Food,
p.000161: Drug and Cosmetic Act (21 U.S.C. 331(jj)), section 303(f)(3) of the Federal Food, Drug and Cosmetic Act (21
p.000161: U.S.C. 333(f)(3)), or any other Fed- eral law.
p.000161:
p.000161: Subpart E—Potential Legal Con- sequences of Non-Compli- ance
p.000161: § 11.66 What are potential legal con- sequences of not complying with the requirements of this part?
p.000161: (a) Civil or criminal judicial actions. Failure to comply with the require- ments of this part,
p.000161: issued under section 402(j) of the Public Health Service Act (42 U.S.C. 282(j)), is a prohibited act
p.000161: under one or more provisions of section 301(jj) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 331(jj)):
p.000161: (1) Failure to submit the certifi-
...
p.000161: Cos- metic Act.
p.000161: (2) Failure to submit clinical trial in-
p.000161: formation required under section 402(j) of the Public Health Service Act is a prohibited act under
p.000161: section 301(jj)(2)
p.000162: 162
p.000162:
p.000162:
p.000162:
p.000162:
p.000162:
p.000162:
p.000162:
p.000162: Public Health Service, HHS § 11.66
p.000162:
p.000162:
p.000162: of the Federal Food, Drug, and Cos- metic Act.
p.000162: (3) Submission of clinical trial infor- mation under section 402(j) that is false or misleading in any
p.000162: particular is a prohibited act under section 301(jj)(3) of the Federal Food, Drug, and Cos- metic
p.000162: Act.
p.000162: (b) Civil monetary penalty actions. Any person who violates section 301(jj) of the Federal Food, Drug, and
p.000162: Cosmetic Act is subject to civil monetary pen- alties under section 303(f)(3) of the Fed- eral Food, Drug,
p.000162: and Cosmetic Act (21
p.000162: U.S.C. 333(f)(3)).
p.000162: (c) Grant funding actions. Under sec- tion 402(j)(5)(A) of the Public Health Service Act (42 U.S.C.
p.000162: 282(j)(5)(A)), if an applicable clinical trial is funded in whole or part by the Department of
p.000162: Health and Human Services, any re-
p.000162:
p.000162: quired grant or progress report forms must include a certification that the responsible party has made all
p.000162: required registration and results submissions. If it is not verified that the required reg- istration and results
p.000162: clinical trial in- formation for each applicable clinical trial for which a grantee is the respon- sible party
p.000162: has been submitted, any re- maining funding for a grant or funding for a future grant to such grantee will not
p.000162: be released. If the head of an HHS agency verifies that a grantee has not submitted such required
p.000162: clinical trial information, the agency head will pro- vide notice to the grantee of the non- compliance
p.000162: and allow the grantee 30 days to correct the non-compliance and submit the required clinical trial infor-
p.000162: mation.
p.000162:
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p.000162:
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p.000162:
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Political / stateless persons
Searching for indicator nation:
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p.000146: responsible party indicating whether the requested ex- tension demonstrates good cause and has been
p.000146: granted.
p.000146: (i) If the extension request is grant- ed, the responsible party must submit clinical trial results
p.000146: information not later than the date of the deadline specified in the electronic response.
p.000146: (ii) If the extension request is denied, the responsible party must either ap- peal in accordance with
p.000146: paragraph (e)(3) of this section or submit clinical trial results information specified in
p.000146: § 11.48 by the later of the submission deadline specified in paragraph (a), (b), (c), (d), (e), or (f) of this
p.000146: section, as ap- plicable, or 30 calendar days after the date on which the electronic notice of the denial
p.000146: is sent to the responsible party.
p.000146: (3) Appealing a denied extension re- quest. (i) A responsible party who seeks to appeal a denied extension
p.000146: request or the deadline specified in a granted ex- tension must submit an appeal to the Director in the
p.000146: format specified at https://prsinfo.clinicaltrials.gov/ not later than 30 calendar days after the date on which
p.000146: the electronic notification of the granting or denial of the request is sent to the responsible party.
p.000146: (ii) An appeal must contain an expla- nation of the reason(s) why the initial decision to deny the extension
p.000146: request or to grant the extension request with a shorter deadline than requested should be
p.000146: overturned or revised, with sufficient detail to allow for the eval- uation of the appeal.
p.000146: (iii) The Director will provide an electronic notification to the respon- sible party indicating
p.000146: whether the re- quested extension has been granted upon appeal.
p.000146: (iv) If the Director grants the exten- sion request upon appeal, the respon- sible party must submit
p.000146: clinical trial results information not later than the deadline specified in the electronic no- tification
p.000146: specified in paragraph (e)(3)(iii) of this section.
p.000147: 147
p.000147:
p.000147:
p.000147:
p.000147:
p.000147:
p.000147:
p.000147:
p.000147:
p.000147: § 11.48
p.000147: (v) If the Director denies the appeal of a denied extension request, the re- sponsible party must
p.000147: submit clinical trial results information by the later of the deadline specified in paragraph (a), (b), (c), (d),
p.000147: (e), or (f) of this section, or
p.000147: 30 calendar days after the electronic notification of the denial of the appeal, specified in paragraph
p.000147: (e)(3)(iii) of this section, is sent to the responsible party.
p.000147: (vi) If the Director denies an appeal of a denied deadline specified in a granted extension
...
Health / Drug Usage
Searching for indicator drug:
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p.000130:
p.000130:
p.000130:
p.000130:
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p.000130:
p.000130:
p.000130: Pt. 11
p.000130: purchase of any covered outpatient drug.
p.000130: (2) A covered entity that is a free- standing cancer hospital cannot use a GPO to purchase orphan
p.000130: drugs when they are transferred, prescribed, sold, or otherwise used for an indication other than the
p.000130: rare condition or dis- ease for which that orphan drug was designated under section 526 of the
p.000130: FFDCA.
p.000130: (3) A covered entity that is a free- standing cancer hospital may use a GPO for purchasing orphan
p.000130: drugs when orphan drugs are transferred, pre- scribed, sold, or otherwise used for the rare disease
p.000130: or condition for which it was designated under section 526 of the FFDCA.
p.000130: (4) If a covered entity that is a free- standing cancer hospital chooses to use a GPO for purchasing an
p.000130: orphan drug used for a rare disease or condition for which it is designated, it is required to maintain
p.000130: auditable records that dem- onstrate full compliance with the or- phan drug purchasing requirements
p.000130: and limitations. A free-standing cancer hospital covered entity that cannot or does not wish to maintain
p.000130: auditable records sufficient to demonstrate com- pliance, must notify HRSA and pur- chase all orphan
p.000130: drugs outside of the 340B Program, regardless of indication for which the drug is used, and is not
p.000130: permitted to use a GPO to purchase those drugs. Once a free-standing can- cer hospital is enrolled in
p.000130: 340B, it may change its decision to purchase all or- phan drugs outside of the 340B Program on a
p.000130: quarterly basis by notifying HRSA. This documentation will be made public. This information will
p.000130: also be verified during the annual recertifi- cation process.
p.000130: (e) Identification of orphan drugs. Des- ignations under section 526 of the FFDCA are the
p.000130: responsibility of and administered by the FDA. Only covered outpatient drugs that match the list- ing and
p.000130: sponsor of the orphan designa- tion are considered orphan drugs for purposes of this section. HRSA
p.000130: will publish on its public Web site FDA’s section 526 list of drugs that will gov- ern the next quarter’s
p.000130: purchases.
p.000130: (f) Failure to comply. Failure to com- ply with this section shall be consid-
p.000130:
p.000130: 42 CFR Ch. I (10–1–16 Edition)
p.000130: ered a violation of sections 340B(a)(5) and 340B(e) of the PHSA, as applicable.
p.000130:
p.000130: PART 11—CLINICAL TRIALS REG- ISTRATION AND RESULTS INFOR- MATION SUBMISSION (Eff. 1-18- 17)
p.000130: Subpart A—General Provisions
p.000130: Sec.
p.000130: 11.2 What is the purpose of this part?
p.000130: 11.4 To whom does this part apply?
p.000130: 11.6 What are the requirements for the sub- mission of truthful information?
p.000130: 11.8 In what format must clinical trial in- formation be submitted?
p.000130: 11.10 What definitions apply to this part?
p.000130: Subpart B—Registration
p.000130: 11.20 Who must submit clinical trial reg- istration information?
p.000130: 11.22 Which applicable clinical trials must be registered?
p.000130: 11.24 When must clinical trial registration information be submitted?
p.000130: 11.28 What constitutes clinical trial reg- istration information?
p.000130: 11.35 By when will the NIH Director post clinical trial registration information submitted under §
p.000130: 11.28?
p.000130: Subpart C—Results Information Submission
p.000130: 11.40 Who must submit clinical trial results information?
p.000130: 11.42 For which applicable clinical trials must clinical trial results information be submitted?
p.000130: 11.44 When must clinical trial results infor- mation be submitted for applicable clin- ical trials subject
p.000130: to § 11.42?
p.000130: 11.48 What constitutes clinical trial results information?
p.000130: 11.52 By when will the NIH Director post submitted clinical trial results informa- tion?
p.000130: 11.54 What are the procedures for requesting a waiver of the requirements for clinical trial results
p.000130: information submission?
p.000130:
p.000130: Subpart D—Additional Submission of Clinical Trial Information
p.000130: 11.60 What requirements apply to the vol- untary submission of clinical trial infor- mation for clinical
p.000130: trials of FDA-regu- lated drug products (including biological products) and device products?
p.000130: 11.62 What requirements apply to applicable clinical trials for which submission of clinical trial
p.000130: information has been deter- mined by the Director to be necessary to protect the public health?
p.000130: 130
p.000130:
p.000130:
p.000130:
p.000130:
p.000130:
p.000130:
p.000130:
p.000130: Public Health Service, HHS § 11.4
p.000130:
p.000130:
p.000130: 11.64 When must clinical trial information submitted to ClinicalTrials.gov be updated or corrected?
p.000130: Subpart E—Potential Legal Consequences of Non-Compliance
p.000130: 11.66 What are potential legal consequences of not complying with the requirements of this part?
p.000130: AUTHORITY: 42 U.S.C. 282(i); 42 U.S.C. 282(j);
p.000130: 5 U.S.C. 301; 42 U.S.C. 286(a); 42 U.S.C. 241(a);
p.000130: 42 U.S.C. 216(b).
p.000130: SOURCE: 81 FR 65138, Sept. 21, 2016, unless
p.000130: otherwise noted.
p.000130: EFFECTIVE DATE NOTE: At 81 FR 65138,
p.000130: Sept. 21, 2016, Part 11 was added, effective
p.000130: Jan. 18, 2017.
p.000130:
p.000130: Subpart A—General Provisions
p.000130: § 11.2 What is the purpose of this part?
p.000130: This part implements section 402(j) of the Public Health Service Act (42
p.000130: U.S.C. 282(j)) by providing require- ments and procedures for the submis- sion of clinical trial
p.000130: information for certain applicable clinical trials and other clinical trials to the Director of the
p.000130: National Institutes of Health (NIH) to be made publicly available via ClinicalTrials.gov, the
...
p.000130: the public health under § 11.62.
p.000130: (b) The responsible party must com-
p.000130: municate the identity and contact in- formation of the responsible party to the Director by submitting the
p.000130: Respon- sible Party, by Official Title and Re- sponsible Party Contact Information data elements under §
p.000130: 11.28(a)(2)(iii)(B) and (a)(2)(iv)(F) as part of the clinical trial information submitted at the time
p.000130: of registration. Changes must be
p.000130:
p.000130: communicated to the Director by up- dating information in accordance with
p.000130: § 11.64(a).
p.000130: (c) Determination of responsible party. For purposes of this part, each applica- ble clinical trial or other
p.000130: clinical trial must have one responsible party. With respect to a clinical trial, the sponsor of the
p.000130: clinical trial will be considered the responsible party unless and until a principal investigator has been
p.000130: des- ignated the responsible party, in ac- cordance with paragraph (c)(2) of this section. With
p.000130: respect to a pediatric postmarket surveillance of a device product that is not a clinical trial, the
p.000130: responsible party is the entity that the
p.000130: U.S. Food and Drug Adminstration (FDA), under section 522 of the Federal Food, Drug, and Cosmetic
p.000130: Act (21
p.000130: U.S.C. 3601), orders to conduct the pedi- atric postmarket surveillance of a de- vice product.
p.000130: (1) Determination of sponsor. For pur- poses of this part, each applicable clin- ical trial or other clinical
p.000130: trial must have one sponsor.
p.000130: (i) When an applicable clinical trial or other clinical trial is conducted under an investigational
p.000130: new drug ap- plication (IND) or investigational de- vice exemption (IDE), the IND or IDE holder will be
p.000130: considered the sponsor.
p.000130: (ii) When an applicable clinical trial or other clinical trial is not conducted under an IND or IDE, the
p.000130: single person or entity who initiates the trial, by preparing and/or planning the trial, and who
p.000130: has authority and control over the trial, will be considered the spon- sor.
p.000130: (2) Designation of a principal investi- gator as the responsible party.
p.000130: (i) The sponsor may designate a prin- cipal investigator as the responsible party if such principal
p.000130: investigator meets all of the following require- ments:
p.000130: (A) Is responsible for conducting the trial;
p.000130: (B) Has access to and control over the data from the trial;
p.000130: (C) Has the right to publish the re- sults of the trial; and
p.000130: (D) Has the ability to meet all of the requirements for submitting and up- dating clinical trial
p.000130: information as specified in this part.
p.000131: 131
p.000131:
p.000131:
p.000131:
p.000131:
p.000131:
p.000131:
p.000131:
p.000131:
p.000131: § 11.6
p.000131: (ii) With regard to an applicable clin- ical trial or other clinical trial, a des- ignation by the sponsor
p.000131: under para- graph (c)(2)(i) of this section shall con- sist of the sponsor obtaining from the principal
...
p.000131: § 11.6 What are the requirements for the submission of truthful informa- tion?
p.000131: The clinical trial information sub- mitted by a responsible party under this part shall not
p.000131: be false or mis- leading in any particular. A responsible party who submits false and/or mis- leading
p.000131: information is subject to civil monetary penalties and/or other civil or criminal remedies available
p.000131: under
p.000131: U.S. law.
p.000131: § 11.8 In what format must clinical trial information be submitted?
p.000131: Information submitted under this part must be submitted electronically to ClinicalTrials.gov, in the
p.000131: format specified at https:// prsinfo.clinicaltrials.gov.
p.000131: § 11.10 What definitions apply to this part?
p.000131: (a) The following definitions apply to terms used in this part:
p.000131: Adverse event means any untoward or unfavorable medical occurrence in a human subject, including any
p.000131: abnor-
p.000131: 42 CFR Ch. I (10–1–16 Edition)
p.000131: mal sign (for example, abnormal phys- ical exam or laboratory finding), symp- tom, or disease, temporally
p.000131: associated with the subject’s participation in the research, whether or not considered re- lated to the
p.000131: subject’s participation in the research. See also the definition of ‘‘serious adverse event.’’
p.000131: Applicable clinical trial means an ap- plicable device clinical trial or an ap- plicable drug clinical
p.000131: trial. Expanded access use under section 561 of the Fed- eral Food, Drug, and Cosmetic Act (21
p.000131: U.S.C. 360bbb) is not an applicable clin- ical trial.
p.000131: Applicable device clinical trial means:
p.000131: (1) A prospective clinical study of health outcomes comparing an inter- vention with a device product
p.000131: subject to section 510(k), 515, or 520(m) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
p.000131: 360(k), 21 U.S.C. 360e, 21
p.000131: U.S.C. 360j(m)) against a control in human subjects (other than a small clinical trial to
p.000131: determine the feasi- bility of a device product, or a clinical trial to test prototype device products
p.000131: where the primary outcome measure relates to feasibility and not to health outcomes);
p.000131: (2) A pediatric postmarket surveil- lance of a device product as required under section 522 of the
p.000131: Federal Food, Drug, and Cosmetic Act (21 U.S.C. 3601); or
p.000131: (3) A clinical trial of a combination product with a device primary mode of action under 21 CFR part 3,
p.000131: provided that it meets all other criteria of the definition under this part.
p.000131: Applicable drug clinical trial means a controlled clinical investigation, other than a phase 1 clinical
p.000131: investigation, of a drug product subject to section 505 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
p.000131: 355) or a biological prod- uct subject to section 351 of the Public Health Service Act (42 U.S.C. 262), where
p.000131: ‘‘clinical investigation’’ has the meaning given in 21 CFR 312.3 and ‘‘phase 1’’ has the meaning
p.000131: given in 21 CFR 312.21. A clinical trial of a com- bination product with a drug primary mode of action
p.000131: under 21 CFR part 3 is also an applicable drug clinical trial, provided that it meets all other cri-
p.000131: teria of the definition under this part.
p.000132: 132
p.000132:
p.000132:
p.000132:
p.000132:
p.000132:
p.000132:
p.000132:
p.000132: Public Health Service, HHS § 11.10
p.000132:
p.000132:
p.000132: Approved drug means a drug product that is approved for any use under sec- tion 505 of the Federal Food, Drug, and
p.000132: Cosmetic Act (21 U.S.C. 355) or a bio- logical product licensed for any use under section 351 of
p.000132: the Public Health Service Act (42 U.S.C. 262).
p.000132: Approved or cleared device means a de- vice product that is cleared for any use under section 510(k) of the
p.000132: Federal Food, Drug, and Cosmetic Act (21 U.S.C 360(k)) or approved for any use under sections 515 or 520(m)
p.000132: of the Federal Food, Drug, and Cosmetic Act (21 U.S.C 360e, 360j(m)).
p.000132: Arm means a pre-specified group or subgroup of human subject(s) in a clin- ical trial assigned to receive
p.000132: specific intervention(s) (or no intervention) ac- cording to a protocol.
p.000132: Clinical study means research accord- ing to a protocol involving one or more human subjects to evaluate biomedical
p.000132: or health-related outcomes, including interventional studies and observa- tional studies.
p.000132: Clinical trial means a clinical inves- tigation or a clinical study in which human subject(s) are
p.000132: prospectively as- signed, according to a protocol, to one or more interventions (or no interven- tion) to
p.000132: evaluate the effect(s) of the intervention(s) on biomedical or health-related outcomes.
p.000132: Clinical trial information means the data elements, including clinical trial registration information
p.000132: and clinical trial results information, that the re- sponsible party is required to submit to
p.000132: ClinicalTrials.gov, as specified in sec- tion 402(j) of the Public Health Service Act (42 U.S.C. 282(j)) and
p.000132: this part.
p.000132: Clinical trial registration information means the data elements that the re- sponsible party is required to
p.000132: submit to ClinicalTrials.gov, as specified in sec- tion 402(j)(2)(A)(ii) of the Public Health Service Act (42
p.000132: U.S.C. 282(j)(2)(A)(ii)) or
p.000132: § 11.28, as applicable.
p.000132: Clinical trial results information means the data elements that the responsible party is required
...
p.000132: the re- sults data collected during the clinical trial.
p.000132: Completion date means, for a clinical trial, including an applicable clinical trial, the date that the
p.000132: final subject was examined or received an interven- tion for the purposes of final collection of data for
p.000132: the primary outcome, whether the clinical trial concluded ac- cording to the pre-specified protocol or was
p.000132: terminated. In the case of clinical trials with more than one primary out- come measure with different comple-
p.000132: tion dates, this term refers to the date on which data collection is completed for all of the primary
p.000132: outcomes. For a pediatric postmarket surveillance of a device product that is not a clinical trial,
p.000132: completion date means the date on which the final report of the pedi- atric postmarket surveillance of
p.000132: the device product is submitted to FDA. For purposes of this part, completion date is referred to as
p.000132: ‘‘primary comple- tion date.’’
p.000132: Control or controlled means, with re-
p.000132: spect to a clinical trial, that data col- lected on human subjects in the clin- ical trial will be
p.000132: compared to concur- rently collected data or to non-concur- rently collected data (e.g., historical controls,
p.000132: including a human subject’s own baseline data), as reflected in the pre-specified primary or secondary out-
p.000132: come measures. For purposes of this part, all clinical trials with one or more arms and
p.000132: pre-specified outcome measure(s) are controlled.
p.000132: Device means a device as defined in section 201(h) of the Federal Food, Drug, and Cosmetic Act
p.000132: (21 U.S.C. 321(h)).
p.000132: Director means the NIH Director or any official of NIH to whom the NIH Director delegates authorities
p.000132: granted in section 402(j) of the Public Health Service Act (42 U.S.C. 282(j)).
p.000132: Drug means a drug as defined in sec- tion 201(g) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
p.000132: 321(g)) or a biological product as defined in section 351 of the Public Health Service Act (42
p.000132: U.S.C. 262).
p.000133: 133
p.000133:
p.000133:
p.000133:
p.000133:
p.000133:
p.000133:
p.000133:
p.000133:
p.000133: § 11.10
p.000133: Enroll or enrolled means a human sub- ject’s, or their legally authorized rep- resentative’s, agreement to
p.000133: participate in a clinical trial following completion of the informed consent process, as re- quired in 21 CFR
p.000133: part 50 and/or 45 CFR part 46, as applicable. For the purposes of this part, potential subjects who are screened
p.000133: for the purpose of determining eligibility for a trial, but do not par- ticipate in the trial, are not
p.000133: considered enrolled, unless otherwise specified by the protocol.
p.000133: Human subjects protection revie board means an institutional review board (IRB) as defined in 21 CFR
p.000133: 50.3 or 45 CFR 46.102, as applicable, that is re- sponsible for assuring the protection of the rights,
p.000133: safety, and well-being of human subjects involved in a clinical trial and is adequately constituted to
p.000133: provide assurance of that protection. An IRB may also be known as an ‘‘independent ethics
p.000133: committee.’’
p.000133: Interventional means, with respect to a clinical study or a clinical investiga- tion, that participants are
p.000133: assigned prospectively to an intervention or interventions according to a protocol to evaluate the
p.000133: effect of the interven- tion(s) on biomedical or other health- related outcomes.
p.000133: Investigational Device Exemption (IDE) has the meaning given in 21 CFR part 812.
p.000133: Investigational Ne Drug Application (IND) has the meaning given in 21 CFR 312.3.
p.000133: NCT number means the unique identi- fication code assigned to each record in ClinicalTrials.gov, including a record
p.000133: for an applicable clinical trial, a clinical trial, or an expanded access program.
p.000133: Ongoing means, with respect to a clinical trial of a drug product (includ- ing a biological product) or
p.000133: a device product and to a date, that one or more human subjects is enrolled in the clin- ical trial, and the
p.000133: date is before the primary completion date of the clinical trial. With respect to a pediatric
p.000133: postmarket surveillance of a device product, ongoing means a date between the date on which FDA approves
p.000133: the plan for conducting the surveillance and the date on which the final report is submitted to FDA.
p.000133: Outcome measure means a pre-speci-
p.000133: fied measurement that will be used to
p.000133: 42 CFR Ch. I (10–1–16 Edition)
p.000133: determine the effect of an experi- mental variable on the human sub- ject(s) in a clinical
p.000133: trial. See also the definitions of ‘‘primary outcome meas- ure’’ and ‘‘secondary outcome meas- ure.’’
p.000133: Pediatric postmarket surveillance of a device product means the active, sys- tematic, scientifically
p.000133: valid collection, analysis, and interpretation of data or other information conducted under sec- tion 522 of the
p.000133: Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360l) about a marketed device product that is ex-
p.000133: pected to have significant use in pa- tients who are 21 years of age or young- er at the time of diagnosis
p.000133: or treat- ment. A pediatric postmarket surveil- lance of a device product may be, but is not always, a clinical
p.000133: trial.
p.000133: Primary completion date means, for
p.000133: purposes of this part, ‘‘completion date.’’ See the definition of ‘‘comple- tion date.’’
p.000133: Primary outcome measure means the outcome measure(s) of greatest impor- tance specified in the protocol,
p.000133: usually the one(s) used in the power calcula- tion. Most clinical trials have one pri- mary outcome
p.000133: measure, but a clinical trial may have more than one. For pur- poses of this part, ‘‘primary outcome’’ has the
p.000133: same meaning as primary out- come measure.
p.000133: Principal investigator means the indi- vidual who is responsible for the over- all scientific and technical
p.000133: direction of the study.
p.000133: Protocol means the written descrip- tion of the clinical trial, including ob- jective(s), design, and
p.000133: methods. It may also include relevant scientific back- ground and statistical considerations.
p.000133: Responsible party means, with respect to a clinical trial, the sponsor of the clinical trial, as defined in
p.000133: 21 CFR 50.3; or the principal investigator of such clinical trial if so designated by a spon- sor, grantee,
p.000133: contractor, or awardee, so long as the principal investigator is re- sponsible for conducting the trial, has
...
p.000134: ability to conduct normal life func- tions, or a congenital anomaly/birth defect. Important medical
p.000134: events that may not result in death, be life-threat- ening, or require hospitalization may be considered serious
p.000134: when, based upon appropriate medical judgment, they may jeopardize the human subject and may require
p.000134: medical or surgical inter- vention to prevent one of the outcomes listed in this definition. Examples of such
p.000134: medical events include allergic bronchospasm requiring intensive treatment in an emergency room
p.000134: or at home, blood dyscrasias or convulsions that do not result in inpatient hos- pitalization, or
p.000134: the development of a substance use disorder.
p.000134: Sponsor means either a ‘‘sponsor’’ or
p.000134: ‘‘sponsor-investigator,’’ as each is de- fined in 21 CFR 50.3.
p.000134: Study completion date means, for a clinical trial, the date the final subject was examined or received an
p.000134: interven- tion for purposes of final collection of data for the primary and secondary outcome
p.000134: measures and adverse events
p.000134:
p.000134: (e.g., last subject’s last visit), whether the clinical trial concluded according to the pre-specified
p.000134: protocol or was ter- minated.
p.000134: U.S. FDA-regulated device product means, for purposes of this part, a de- vice product subject to
p.000134: section 510(k), 515, 520(m), or 522 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360(k),
p.000134: 21 U.S.C. 360e, 21 U.S.C. 360j(m), 21 U.S.C. 360l).
p.000134: U.S. FDA-regulated drug product means, for purposes of this part, a drug product subject to section
p.000134: 505 of the Federal Food, Drug, and Cosmetic Act or a biological product subject to sec- tion 351 of the
p.000134: Public Health Service Act (21 U.S.C. 355, 42 U.S.C. 262) .
p.000134: (b) The following definitions apply to data elements of clinical trial informa- tion referenced in this part, unless
p.000134: oth- erwise specified:
p.000134: (1) Brief Title means a short title of the clinical trial written in language intended for the lay
p.000134: public, including any acronym or abbreviation used pub- licly to identify the clinical trial.
p.000134: (2) Official Title means the title of the clinical trial, corresponding to the title of the protocol.
p.000134: (3) Brief Summary means a short de- scription of the clinical trial, including a brief statement of the
p.000134: clinical trial’s hypothesis, written in language in- tended for the lay public.
p.000134: (4) Primary Purpose means the main objective of the intervention(s) being evaluated by the clinical trial.
p.000134: (5) Study Design means a description of the manner in which the clinical trial will be conducted,
p.000134: including the following information:
p.000134: (i) Interventional Study Model. The strategy for assigning interventions to human subjects.
p.000134: (ii) Number of Arms. The number of arms in the clinical trial. For a trial with multiple periods or
p.000134: phases that have different numbers of arms, it means the maximum number of arms during all periods or
p.000134: phases.
p.000134: (iii) Arm Information. A description of each arm of the clinical trial that indi- cates its role in the clinical
p.000134: trial, pro- vides an informative title, and, if nec- essary, additional descriptive informa- tion (including
p.000134: which interventions are
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p.000135:
p.000135:
p.000135:
p.000135:
p.000135:
p.000135:
p.000135:
p.000135:
p.000135: § 11.10
p.000135: administered in each arm) to differen- tiate each arm from other arms in the clinical trial.
p.000135: (iv) Allocation. The method by which human subjects are assigned to arms in a clinical trial.
p.000135: (v) Masking. The party or parties, if any, involved in the clinical trial who are prevented from having
p.000135: knowledge of the interventions assigned to indi- vidual human subjects.
p.000135: (6) Study Phase means, for a clinical trial of a drug product (including a bio- logical product), the
p.000135: numerical phase of such clinical trial, consistent with terminology in 21 CFR 312.21, such as phase 2 or
p.000135: phase 3, and in 21 CFR 312.85 for phase 4 studies.
p.000135: (7) Study Type means the nature of the investigation or investigational use for which clinical trial
p.000135: information is being submitted, e.g., interventional, observational.
p.000135: (8) Pediatric Postmarket Surveillance of a Device Product means a clinical trial or study that includes a
p.000135: U.S. FDA-reg- ulated device product as an interven- tion and is a pediatric postmarket sur- veillance of a
p.000135: device product ordered under section 522 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 369l).
p.000135: (9) Primary Disease or Condition Being
p.000135: Studied in the Trial, or the Focus of the Study means the name(s) of the dis- ease(s) or
p.000135: condition(s) studied in the clinical trial, or the focus of the clin- ical trial. Use, if available,
p.000135: appropriate descriptors from NLM’s Medical Sub- ject Headings (MeSH)-controlled vocab- ulary thesaurus or terms
p.000135: from another vocabulary, such as the Systematized Nomenclature of Medicine—Clinical Terms (SNOMED CT),
p.000135: that has been mapped to MeSH within the Unified Medical Language System (UMLS) Metathesaurus.
p.000135: (10) Intervention Name(s) means a brief
p.000135: descriptive name used to refer to the intervention(s) studied in each arm of the clinical trial. A
p.000135: non-proprietary name of the intervention must be used, if available. If a non-proprietary name is not
p.000135: available, a brief descriptive name or identifier must be used.
p.000135: (11) Other Intervention Name(s) means other current and former name(s) or alias(es), if any, different
p.000135: from the Intervention Name(s), that the sponsor has used publicly to identify the inter-
p.000135: 42 CFR Ch. I (10–1–16 Edition)
p.000135: vention(s), including, but not limited to, past or present names such as brand name(s), or serial numbers.
p.000135: (12) Intervention Description means de- tails that can be made public about the intervention, other than the
p.000135: Interven- tion Name(s) and Other Intervention Name(s), sufficient to distinguish the intervention from
p.000135: other, similar inter- ventions studied in the same or an- other clinical trial. For example, inter-
p.000135: ventions involving drugs may include dosage form, dosage, frequency, and du- ration.
p.000135: (13) Intervention Type means, for each intervention studied in the clinical trial, the general type of
p.000135: intervention, e.g., drug, biological/vaccine, or, de- vice.
p.000135: (14) Device Product Not Approved or Cleared by U.S. FDA means that at least one device product
p.000135: studied in the clinical trial has not been previously approved or cleared by FDA for one or more uses.
p.000135: (15) Product Manufactured in and Ex- ported from the U.S. means that any drug product (including
p.000135: a biological product) or device product studied in the clinical trial is manufactured in the United
p.000135: States or one of its terri- tories and exported for study in a clin- ical trial in another country.
p.000135: (16) Study Start Date means the esti- mated date on which the clinical trial will be open for
p.000135: recruitment of human subjects, or the actual date on which the first human subject was enrolled.
p.000135: (17) Primary Completion Date means the estimated or actual primary com- pletion date. If an estimated
p.000135: primary completion date is used, the respon- sible party must update the Primary Completion Date
p.000135: data element once the clinical trial has reached the pri- mary completion date to reflect the ac- tual
p.000135: primary completion date.
p.000135: (18) Enrollment means the estimated total number of human subjects to be enrolled (target number) or the
p.000135: actual total number of human subjects that are enrolled in the clinical trial. Once the trial has reached
p.000135: the primary com- pletion date, the responsible party must update the Enrollment data ele- ment to
p.000135: reflect the actual number of human subjects enrolled in the clinical trial.
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p.000136:
p.000136:
p.000136:
p.000136:
p.000136:
p.000136:
p.000136: Public Health Service, HHS § 11.10
p.000136:
p.000136:
p.000136: (19) Primary Outcome Measure Informa- tion means a description of each pri- mary outcome measure, to include
...
p.000136: the clin- ical trial.
p.000136: (23) Age Limits means the minimum and maximum age of human subjects who may participate in the
p.000136: clinical trial, provided in relevant units of time.
p.000136: (24) Accepts Healthy Volunteers means that human subjects who do not have a disease or condition, or related
p.000136: condi- tions or symptoms, under study in the clinical trial are permitted to partici- pate in the clinical
p.000136: trial.
p.000136: (25) Overall Recruitment Status means the recruitment status for the clinical trial as a whole, based on the
p.000136: status of the individual sites. If at least one fa- cility in a multi-site clinical trial has an
p.000136: individual site status of ‘‘recruit- ing,’’ then the overall recruitment sta- tus for the trial must be
p.000136: ‘‘recruiting.’’
p.000136: (26) Why Study Stopped means, for a clinical trial that is suspended or ter- minated or withdrawn
p.000136: prior to its planned completion as anticipated by the protocol, a brief explanation of the
p.000136:
p.000136: reason(s) why the clinical trial was stopped.
p.000136: (27) Individual Site Status means the recruitment status of each partici- pating facility in a
p.000136: clinical trial.
p.000136: (28) Availability of Expanded Access means, for an applicable drug clinical trial of a drug product
p.000136: (including a bio- logical product) that is not an ap- proved drug product (including a bio- logical
p.000136: product), and for which the re- sponsible party is both the manufac- turer of the drug product
p.000136: (including a biological product) and the sponsor of the applicable clinical trial:
p.000136: (i) An indication of whether there is expanded access to the investigational drug product (including a
p.000136: biological product) under section 561 of the Fed- eral Food, Drug, and Cosmetic Act (21
p.000136: U.S.C. 360bbb) for those individuals who do not qualify for enrollment in the applicable clinical
p.000136: trial, under one or more of the following types of ex- panded access programs: for individual patients,
p.000136: including for emergency use, as specified in 21 CFR 312.310; for inter- mediate-size patient populations, as
p.000136: specified in 21 CFR 312.315; or under a treatment IND or treatment protocol, as specified in 21 CFR 312.320;
p.000136: and
p.000136: (ii) If expanded access is available under section 561 of the Federal Food, Drug, and Cosmetic
p.000136: Act (21 U.S.C. 360bbb), the NCT number of the ex- panded access record.
p.000136: (29) Name of the Sponsor means the name of the entity or individual who is the sponsor of the clinical
p.000136: trial, as de- fined in this part.
p.000136: (30) Responsible Party, by Official Title
p.000136: means an:
p.000136: (i) Indication of whether the respon- sible party is the sponsor of the clin- ical trial, as that term
p.000136: is defined in 21 CFR 50.3; the sponsor-investigator, as that term is defined in 21 CFR 50.3; or a
p.000136: principal investigator designated pursuant to this part; and
p.000136: (ii) Either:
p.000136: (A) The official name of the entity, if the responsible party is an entity; or
p.000136: (B) The official title and primary or- ganizational affiliation of the indi- vidual, if the responsible
p.000136: party is an in- dividual.
p.000136: (31) Facility Information means, for each participating facility in a clinical trial, the following
p.000136: information:
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p.000137:
p.000137:
p.000137:
p.000137:
p.000137:
p.000137:
p.000137:
p.000137:
p.000137: § 11.10
p.000137: (i) Facility Name, meaning the full name of the organization where the clinical trial is being
p.000137: conducted;
p.000137: (ii) Facility Location, including city, state, country and zip code for U.S. lo- cations (including territories
p.000137: of the United States) and city and country for locations in other countries; and
p.000137: (iii) Either:
p.000137: (A) For each facility participating in a clinical trial, Facility Contact, in- cluding the name or
p.000137: title, telephone number, and email address of a person to whom questions concerning the trial and enrollment
p.000137: at that site can be ad- dressed; or
p.000137: (B) Central Contact Person, including the name or title, toll-free telephone number, and email address of a
p.000137: person to whom questions concerning enroll- ment at any location of the trial can be addressed.
p.000137: (32) Unique Protocol Identification Number means any unique identifier as- signed to the protocol by the
p.000137: sponsor.
p.000137: (33) Secondary ID means:
p.000137: (i) Any identifier(s) other than the organization’s unique protocol identi- fier or NCT number that is assigned
p.000137: to the clinical trial, including any unique clinical trial identifiers assigned by other publicly available
p.000137: clinical trial registries. If the clinical trial is funded in whole or in part by a U.S. Federal Government
p.000137: agency, the complete grant or contract number must be sub- mitted as a Secondary ID.
p.000137: (ii) A description of the type of Sec- ondary ID.
p.000137: (34) U.S. Food and Drug Administration IND or IDE Number means an indication of whether there is an IND or IDE
p.000137: for the clinical trial and, if so, each of the following elements:
p.000137: (i) Name or abbreviation of the FDA center with whom the IND or IDE is filed;
p.000137: (ii) IND or IDE number assigned by the FDA center; and
p.000137: (iii) For an IND, the IND serial num- ber, as defined in 21 CFR 312.23(e), if any, assigned to the clinical
p.000137: trial.
p.000137: (35) Human Subjects Protection Revie Board Status means information to in- dicate whether a clinical trial
p.000137: has been reviewed and approved by a human sub- jects protection review board or wheth- er such review is not
p.000137: required per ap- plicable law (e.g., 21 CFR part 56, 45
p.000137: 42 CFR Ch. I (10–1–16 Edition)
p.000137: CFR part 46, or other applicable regula- tion). Human Subjects Protection Re- view Board Status must be listed
p.000137: as ‘‘approved’’ if at least one human sub- jects protection review board has ap- proved the clinical trial.
p.000137: (36) Record Verification Date means the date on which the responsible party last verified the clinical
p.000137: trial informa- tion in the entire ClinicalTrials.gov record for the clinical trial, even if no
p.000137: additional or updated information was submitted at that time.
p.000137: (37) Responsible Party Contact Informa- tion means administrative information to identify and allow
p.000137: communication with the responsible party by tele- phone, email, and regular mail or de- livery
p.000137: service. Responsible Party Con- tact Information includes the name, of- ficial title, organizational
p.000137: affiliation, physical address, mailing address, phone number, and email address of the individual who is
p.000137: the responsible party or of a designated employee of the or- ganization that is the responsible
p.000137: party.
p.000137: (38) Studies a U.S. FDA-regulated De-
p.000137: vice Product means that a clinical trial studies a device product subject to sec- tion 510(k), 515, or 520(m) of
p.000137: the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360(k), 21 U.S.C. 360e, 21 U.S.C. 360j(m)).
p.000137: (39) Studies a U.S. FDA-regulated Drug Product means a clinical trial studies a drug product (including a
p.000137: biological product) subject to section 505 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355) or
p.000137: section 351 of the Pub- lic Health Service Act (42 U.S.C. 262).
p.000137: (40) Post Prior to U.S. FDA Approval or Clearance means, for an applicable de- vice clinical trial of a
p.000137: device product that has not been previously approved or cleared, the responsible party indi- cates to the
p.000137: Director that it is author- izing the Director, in accordance with
p.000137: § 11.35(b)(2)(ii), to publicly post its clin- ical trial registration information, which would otherwise
p.000137: be subject to delayed posting, as specified in
p.000137: § 11.35(b)(2)(i), prior to the date of FDA approval or clearance of its device product.
p.000137: (41) Study Completion Date means the estimated or actual study completion date. Once the clinical
p.000137: trial has reached the study completion date, the
p.000138: 138
p.000138:
p.000138:
p.000138:
p.000138:
p.000138:
p.000138:
p.000138:
p.000138: Public Health Service, HHS § 11.24
p.000138:
p.000138:
p.000138: responsible party must update the Study Completion Date data element to reflect the actual study
p.000138: completion date in accordance with
p.000138: § 11.64(a)(1)(ii)(J) .
p.000138: Subpart B—Registration
p.000138: § 11.20 Who must submit clinical trial registration information?
p.000138: The responsible party for an applica- ble clinical trial specified in § 11.22 must submit clinical
p.000138: trial registration information for that clinical trial.
p.000138: § 11.22 Which applicable clinical trials must be registered?
p.000138: (a) General specification. (1) Any appli- cable clinical trial that is initiated after September 27, 2007,
p.000138: must be reg- istered.
p.000138: (2) Any applicable clinical trial that is initiated on or before September 27, 2007, and is ongoing on
p.000138: December 26, 2007, must be registered.
p.000138: (3) Determining the date of initiation for an applicable clinical trial. An appli- cable clinical
p.000138: trial, other than a pedi- atric postmarket surveillance of a de- vice product that is not a clinical trial, is
p.000138: considered to be initiated on the date on which the first human subject is enrolled. A pediatric
p.000138: postmarket sur- veillance of a device product that is not a clinical trial is considered to be initiated
p.000138: on the date on which FDA ap- proves the plan for conducting the sur- veillance.
p.000138: (b) Determination of applicable clinical
p.000138: trial for a clinical trial or study initiated on or after January 18, 2017. A clinical trial or study
p.000138: that, at any point in time, meets the conditions listed in paragraph (b)(1) or (2) of this
p.000138: section will be considered to meet the defini- tion of an applicable clinical trial.
p.000138: (1) Applicable device clinical trial. A clinical trial or study that meets the conditions listed in
p.000138: either paragraph (b)(1)(i) or (ii) of this section is an ap- plicable device clinical trial:
p.000138: (i) The study is a pediatric postmarket surveillance of a device product as required by
p.000138: FDA under sec- tion 522 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 3601).
p.000138: (ii) The study is a clinical trial with one or more arms that meets all of the following criteria:
p.000138:
p.000138: (A) Study Type is interventional;
p.000138: (B) Primary Purpose of the clinical trial is other than a feasibility study;
p.000138: (C) The clinical trial Studies a U.S.
p.000138: FDA-regulated Device Product; and
p.000138: (D) One or more of the following ap- plies:
p.000138: (1) At least one Facility Location is within the United States or one of its territories,
p.000138: (2) A device product under investiga- tion is a Product Manufactured in and Exported from the U.S. or
p.000138: one of its territories for study in another coun- try, or
p.000138: (3) The clinical trial has a U.S. Food and Drug Administration IDE Number.
p.000138: (2) Applicable drug clinical trial. A clinical trial with one or more arms that meets the following
p.000138: conditions is an applicable drug clinical trial:
p.000138: (i) Study Type is interventional;
p.000138: (ii) Study Phase is other than phase
p.000138: 1;
p.000138: (iii) The clinical trial Studies a U.S.
p.000138: FDA-regulated Drug Product; and
p.000138: (iv) One or more of the following ap- plies:
p.000138: (A) At least one Facility Location for the clinical trial is within the United States or one of its territories,
p.000138: (B) A drug product (including a bio- logical product) under investigation is a Product Manufactured in
p.000138: and Ex- ported from the U.S. or one of its terri- tories for study in another country, or
p.000138: (C) The clinical trial has a U.S. Food and Drug Administration IND Number.
p.000138:
p.000138: § 11.24 When must clinical trial reg- istration information be submitted?
p.000138: (a) General. Except as provided in paragraph (b) of this section, the re- sponsible party for an
p.000138: applicable clin- ical trial for which submission of clin- ical trial registration information is
p.000138: required must submit the clinical trial registration information specified in section 402(j)(2)(A)(ii)
p.000138: of the Public Health Service Act (42 U.S.C. 282(j)(2)(A)(ii)) or § 11.28(a), as applica-
p.000138: ble, not later than December 26, 2007, or 21 calendar days after the first human subject is
p.000138: enrolled, whichever date is later.
p.000138: (b) Exceptions:. (1) The responsible party for an applicable clinical trial that is a clinical
p.000138: trial and for which
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p.000139:
p.000139:
p.000139:
p.000139:
p.000139:
p.000139:
p.000139:
p.000139:
p.000139: § 11.28
p.000139: the submission of clinical trial reg- istration information is required and that is not for a
p.000139: serious or life-threat- ening disease or condition must submit clinical trial registration information as
p.000139: specified in section 402(j)(2)(A)(ii) of the Public Health Service Act (42 U.S.C.
p.000139: 282(j)(2)(A)(ii)) or § 11.28(a), as
p.000139: applicable, not later than September 27, 2008, or 21 calendar days after the first human subject is
p.000139: enrolled, which- ever date is later.
p.000139: (2) The responsible party for an appli- cable device clinical trial that is a pe- diatric postmarket
p.000139: surveillance of a device product and is not a clinical trial must submit clinical trial reg-
p.000139: istration information, as specified in section 402(j)(2)(A)(ii) of the Public Health Service
p.000139: Act (42 U.S.C. 282(j)(2)(A)(ii)) or § 11.28(b), not later than December 26, 2007, or 21
p.000139: calendar days after FDA approves the postmarket surveillance plan, which- ever date is later.
p.000139: § 11.28 What constitutes clinical trial registration information?
p.000139: (a) For each applicable clinical trial that must be registered with ClinicalTrials.gov, other
p.000139: than a pedi- atric postmarket surveillance of a de- vice product that is not a clinical trial, the responsible
p.000139: party must submit the following information:
p.000139: (1) For such applicable clinical trials that were initiated before January 18, 2017, the responsible party
p.000139: must submit the information specified in section 402(j)(2)(A)(ii) of the Public Health Service Act
p.000139: (42 U.S.C. 282(j)(2)(A)(ii)).
p.000139: (2) For such applicable clinical trials that are initiated on or after January 18, 2017, the
p.000139: responsible party must submit the data elements listed below:
p.000139: (i) Descriptive information:
p.000139: (A) Brief Title;
p.000139: (B) Official Title;
p.000139: (C) Brief Summary;
p.000139: (D) Primary Purpose;
p.000139: (E) Study Design;
p.000139: (F) Study Phase, for an applicable drug clinical trial;
p.000139: (G) Study Type;
p.000139: (H) Pediatric Postmarket Surveil- lance of a Device Product, for an appli- cable device clinical trial that
p.000139: is a Pe- diatric Postmarket Surveillance of a Device Product;
p.000139: 42 CFR Ch. I (10–1–16 Edition)
p.000139: (I) Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study;
p.000139: (J) Intervention Name(s), for each intervention studied;
p.000139: (K) Other Intervention Name(s), for each intervention studied;
p.000139: (L) Intervention Description, for each intervention studied;
p.000139: (M) Intervention Type, for each intervention studied;
p.000139: (N) Studies a U.S. FDA-regulated De- vice Product;
p.000139: (O) Studies a U.S. FDA-regulated Drug Product;
p.000139: (P) Device Product Not Approved or Cleared by U.S. FDA, if any studied intervention is a device product;
p.000139: (Q) Post Prior to U.S. FDA Approval or Clearance, for an applicable device clinical trial that studies
p.000139: at least one device product not previously approved or cleared by the U.S. FDA;
p.000139: (R) Product Manufactured in and Ex- ported from the U.S., if the entry for
p.000139: U.S. Food and Drug Administration IND or IDE Number in
p.000139: § 11.28(a)(2)(iv)(C) indicates that there is no IND or IDE for the clinical trial, and the entry(ies) for
p.000139: Facility Informa- tion in § 11.28(a)(2)(iii)(C) include no fa- cility locations in the United States or its
p.000139: territories;
p.000139: (S) Study Start Date;
p.000139: (T) Primary Completion Date;
p.000139: (U) Study Completion Date;
p.000139: (V) Enrollment;
p.000139: (W) Primary Outcome Measure Infor- mation, for each primary outcome measure; and
p.000139: (X) Secondary Outcome Measure In- formation, for each secondary outcome measure.
p.000139: (ii) Recruitment information:
p.000139: (A) Eligibility Criteria;
p.000139: (B) Sex/Gender;
p.000139: (C) Age Limits;
p.000139: (D) Accepts Healthy Volunteers;
p.000139: (E) Overall Recruitment Status;
p.000139: (F) Why Study Stopped;
p.000139: (G) Individual Site Status; and
p.000139: (H) Availability of Expanded Access. If expanded access is available for an investigational drug product
p.000139: (including a biological product), an expanded ac- cess record must be submitted in ac- cordance with §
p.000139: 11.28(c), unless an ex- panded access record was submitted
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p.000140:
p.000140:
p.000140:
p.000140:
p.000140:
p.000140:
p.000140: Public Health Service, HHS § 11.28
p.000140:
p.000140:
p.000140: previously in accordance with that pro- vision.
p.000140: (iii) Location and contact informa- tion:
p.000140: (A) Name of the Sponsor;
p.000140: (B) Responsible Party, by Official Title; and
p.000140: (C) Facility Information.
p.000140: (iv) Administrative data:
p.000140: (A) Unique Protocol Identification Number;
p.000140: (B) Secondary ID;
p.000140: (C) U.S. Food and Drug Administra- tion IND or IDE Number;
p.000140: (D) Human Subjects Protection Re- view Board Status;
p.000140: (E) Record Verification Date; and
p.000140: (F) Responsible Party Contact Infor- mation.
p.000140: (b) Pediatric postmarket surveillance of a device product that is not a clin- ical trial. For
p.000140: each pediatric postmarket surveillance of a device product that is not a clinical trial, the responsible
p.000140: party must submit the fol- lowing information:
p.000140: (1) For such applicable device clinical trials that were initiated before Janu- ary 18, 2017, the responsible
p.000140: party must submit the information specified in section 402(j)(2)(A)(ii) of the Public Health
p.000140: Service Act (42 U.S.C. 282(j)(2)(A)(ii)).
p.000140: (2) For such applicable device clinical trials that are initiated on or after January 18, 2017, the
p.000140: responsible party must submit the data elements listed below:
p.000140: (i) Descriptive information:
p.000140: (A) Brief Title. A short title of the pe- diatric postmarket surveillance of a device product in language
p.000140: intended for the lay public. If an acronym or abbre- viation is used to publicly identify the surveillance, it
p.000140: must be provided.
p.000140: (B) Official Title. The title of the pedi- atric postmarket surveillance of a de- vice product, corresponding to
p.000140: the title of the protocol or the FDA-approved plan for conducting the surveillance
...
p.000141: postmarket sur- veillance.
p.000141: (D) Record Verification Date. The date on which the responsible party last verified the clinical
p.000141: trial information in the entire ClinicalTrials.gov record for the pediatric postmarket surveil- lance of a
p.000141: device product, even if no ad- ditional or updated information was submitted at that time
p.000141: (E) Responsible Party Contact Informa- tion. Administrative information suffi- cient to identify and allow
p.000141: communica- tion with the responsible party by tele- phone, email, and regular mail or de- livery service.
p.000141: Responsible Party Con- tact Information includes the name, of- ficial title, organizational affiliation,
p.000141: physical address, mailing address, phone number, and email address of the individual who is the responsible
p.000141: party or of a designated employee of the or- ganization that is the responsible party.
p.000141: (c) Expanded access record. If ex- panded access is available, as specified in 21 CFR 312.315
p.000141: (for an intermediate- size patient population) or 21 CFR
p.000141: 312.320 (under a treatment IND or treatment protocol), for an investiga- tional drug product
p.000141: (including a bio- logical product) studied in an applica- ble drug clinical trial, and the data ele- ments set
p.000141: forth in paragraphs (c)(1) through (4) of this section have not been submitted in an expanded
p.000141: access record for that investigational product, the responsible party, if both the man- ufacturer of the
p.000141: investigational prod- uct and the sponsor of the applicable clinical trial, must submit the clinical trial
p.000141: information specified in para- graphs (c)(1) through (4) of this section to ClinicalTrials.gov in the form
p.000141: of an expanded access record. If expanded ac- cess is available only as specified in 21 CFR 312.310 (for
p.000141: individual patients, in- cluding for emergency use) for an in- vestigational drug product (including a biological
p.000141: product) studied in an appli- cable drug clinical trial, and the data elements set forth in
p.000141: paragraphs (c)(1)(i), (iii), (iv), (vi), (ix), (x), (c)(2)(iv), (c)(3), (c)(4)(i), (iii),(iv),
p.000141: and
p.000141: (v) of this section have not been sub-
p.000141: mitted in an expanded access record for
p.000142: 142
p.000142:
p.000142:
p.000142:
p.000142:
p.000142:
p.000142:
p.000142:
p.000142: Public Health Service, HHS § 11.28
p.000142:
p.000142:
p.000142: that investigational product, the re- sponsible party, if both the manufac- turer of the
p.000142: investigational product and the sponsor of the applicable clin- ical trial, must submit the clinical
p.000142: trial information specified in those paragraphs to ClinicalTrials.gov in the form of an expanded access
p.000142: record.
p.000142: (1) Descriptive information:
p.000142: (i) Brief Title. A short title identi- fying the expanded access, written in language intended for the
p.000142: lay public. If an acronym or abbreviation is used publicly to identify the expanded ac- cess, it must be
p.000142: provided.
p.000142: (ii) Official Title. The title, if any, of the expanded access program cor- responding to the
p.000142: title that has been submitted to FDA for that program
p.000142: (iii) Brief Summary. A short descrip- tion of the availability of expanded ac- cess, including the procedure
p.000142: for re- questing the investigational drug prod- uct (including a biological product).
p.000142: (iv) Study Type. The nature of the in- vestigation or investigational use for which clinical trial
p.000142: information is being submitted, i.e., ‘‘expanded ac- cess’’.
p.000142: (v) Primary Disease or Condition. The name(s) of the disease(s) or condi- tion(s) for which
p.000142: expanded access to the investigational drug product (in- cluding a biological product) is avail- able.
p.000142: Use, if available, appropriate descriptors from NLM’s MeSH-con- trolled vocabulary thesaurus,
p.000142: or terms from another vocabulary, such as the SNOMED CT, that has been mapped to MeSH within
p.000142: the UMLS Metathesaurus.
p.000142: (vi) Intervention Name(s). A brief de- scriptive name used to refer to the in- vestigational drug product
p.000142: (including a biological product) that is available through expanded access. A non-propri- etary name of the
p.000142: intervention must be used, if available. If a non-proprietary name is not available, a brief descrip- tive
p.000142: name or identifier must be used.
p.000142: (vii) Other Intervention Name(s). Any other current and former name(s) or alias(es), different from the
p.000142: Interven- tion Name(s), that the sponsor has used publicly to identify the intervention, including, but not
p.000142: limited to, past or present names such as brand name(s), or serial numbers.
p.000142:
p.000142: (viii) Intervention Description. Details that can be made public about each intervention, other than
p.000142: the Interven- tion Name(s) or Other Intervention Name(s), sufficient to distinguish the intervention from
p.000142: other, similar inter- ventions that are available through ex- panded access or in clinical trials.
p.000142: (ix) Intervention Type. For each inves- tigational drug product (including a bi- ological product) for which
p.000142: expanded access is available, the general type of intervention, e.g., drug.
p.000142: (x) Expanded Access Type. The type(s) of expanded access for which the inves- tigational drug product (including a
p.000142: bi- ological product) is available, as speci- fied in § 11.10(b)(28).
p.000142: (2) Recruitment information:
p.000142: (i) Eligibility Criteria. A limited list of criteria for determining who is eligible to receive the
p.000142: investigational drug product (including a biological prod- uct) through expanded access, provided in terms
p.000142: of inclusion and exclusion cri- teria and suitable for assisting poten- tial patients in identifying
p.000142: investiga- tional drug products (including biologi- cal products) of interest for which ex- panded access is
p.000142: available.
p.000142: (ii) Sex/Gender. The sex and gender (if applicable) of the patients for whom expanded access is available.
p.000142: (iii) Age Limits. The minimum and maximum age of patients for whom ex- panded access is available,
p.000142: provided in relevant units of time.
p.000142: (iv) Expanded Access Status. The sta- tus of availability of the investiga- tional drug product
p.000142: (including a bio- logical product) through expanded ac- cess.
p.000142: (3) Contact information:
p.000142: (i) Name of the Sponsor.
p.000142: (ii) Responsible Party, by Official Title.
p.000142: The official name of the entity.
p.000142: (iii) Contact Information. The name or official title, toll-free telephone num- ber, and email address of a
p.000142: person to whom questions concerning expanded access can be addressed.
p.000142: (4) Administrative data:
p.000142: (i) Unique Protocol Identification Num- ber. Any unique identifier assigned by the sponsor to refer to
p.000142: the availability of its investigational drug product (in- cluding a biological product) for ex- panded
p.000142: access use or to identify the ex- panded access record.
p.000143: 143
p.000143:
p.000143:
p.000143:
p.000143:
p.000143:
p.000143:
p.000143:
p.000143:
p.000143: § 11.35
p.000143: (ii) Secondary ID: (A) Any identi- fier(s) other than the Unique Protocol Identification Number or
p.000143: the NCT number that is assigned to the ex- panded access record, including any unique
p.000143: identifiers assigned by other publicly available clinical trial or ex- panded access registries.
p.000143: (B) For each Secondary ID listed, a description of the type of Secondary ID.
p.000143: (iii) U.S. Food and Drug Administra- tion IND Number. An indication of whether there is an IND
p.000143: and, if so, each of the following elements:
p.000143: (A) Name or abbreviation of the FDA center with whom the IND is filed (i.e., CDER or CBER), if applicable;
p.000143: (B) IND number (assigned by the FDA center) under which the investiga- tional drug product (including a
p.000143: bio- logical product) is being made avail- able for expanded access, if applicable; and
p.000143: (C) IND serial number. as defined in 21 CFR 312.23(e), if any, assigned to the expanded access.
p.000143: (iv) Record Verification Date. The date on which the responsible party last verified the information
p.000143: in the ex- panded access record, even if no addi- tional or updated information was sub- mitted at that time.
p.000143: (v) Responsible Party Contact Informa- tion. Administrative information suffi- cient to identify and allow
p.000143: communica- tion with the responsible party enter- ing the clinical trial information into the expanded
p.000143: access record by tele- phone, email, and regular mail or de- livery service. Responsible Party Con-
p.000143: tact Information includes the name, of- ficial title, organizational affiliation, physical address,
p.000143: mailing address, phone number, and email address of the individual who is the responsible party or of a
p.000143: designated employee of the or- ganization that is the responsible party.
p.000143: § 11.35 By when will the NIH Director post clinical trial registration infor- mation submitted under § 11.28?
p.000143: (a) Applicable drug clinical trial. The Director will post publicly on ClinicalTrials.gov the
p.000143: clinical trial reg- istration information, except for cer- tain administrative data, for an appli- cable
p.000143: drug clinical trial not later than
p.000143: 42 CFR Ch. I (10–1–16 Edition)
p.000143: 30 calendar days after the responsible party has submitted such information, as specified in § 11.24.
p.000143: (b) Applicable device clinical trial. (1) For an applicable device clinical trial of a device product that
p.000143: was previously approved or cleared, the Director will post publicly on ClinicalTrials.gov the clinical trial
p.000143: registration information, except for certain administrative data, as soon as practicable, but not later
p.000143: than 30 calendar days after clinical trial results information is required to be posted, as specified in
p.000143: § 11.52.
p.000143: (2) For an applicable device clinical trial of a device product that has not been previously approved or
p.000143: cleared:
p.000143: (i) The Director will post publicly on ClinicalTrials.gov the clinical trial reg- istration information, except
p.000143: for cer- tain administrative data, not earlier than the date of FDA approval or clear- ance of the
p.000143: device product and not later than 30 calendar days after the date of such approval or clearance, ex-
p.000143: cept as otherwise provided in para- graph (b)(2)(ii) of this section.
p.000143: (ii) If, prior to the date of approval or clearance of the device product, the re- sponsible party for an
p.000143: applicable clin- ical trial that is initiated on or after January 18, 2017, indicates to the Direc- tor, by
p.000143: submitting the Post Prior to
p.000143: U.S. FDA Approval or Clearance data element under § 11.28(a)(2)(i)(Q), that it is authorizing the Director
...
p.000144: by FDA. Unless a waiver of the requirement to submit clinical trial results information is granted
p.000144: in accordance with § 11.54, clin- ical trial results information specified in § 11.48 must be submitted for any ap-
p.000144: plicable clinical trial with a primary completion date on or after January 18, 2017 for which clinical trial
p.000144: registra- tion information is required to be sub- mitted and for which the studied prod- uct is not
p.000144: approved, licensed, or cleared by FDA.
p.000144: § 11.44 When must clinical trial results information be submitted for appli- cable clinical trials
p.000144: subject to
p.000144: § 11.42?
p.000144: (a) Standard submission deadline. In general, for applicable clinical trials subject to § 11.42,
p.000144: clinical trial results information specified in sections 402(j)(3)(C) and 402(j)(3)(I) of the
p.000144: Public Health Service Act (42 U.S.C. 282(j)(3)(C) and 42 U.S.C. 282(j)(3)(I)) or in § 11.48,
p.000144: as applicable, must be sub- mitted no later than 1 year after the primary completion date of the appli-
p.000144: cable clinical trial.
p.000144:
p.000144: (b) Delayed submission of results infor- mation ith certification if seeking ap- proval, licensure,
p.000144: or clearance of a ne use—(1) General requirements. If, prior to the results information submission
p.000144: deadline specified under paragraph (a) of this section, the responsible party submits a certification that an
p.000144: applica- ble clinical trial involves an FDA-regu- lated drug product (including a biologi- cal product) or device
p.000144: product that pre- viously has been approved, licensed, or cleared, for which the manufacturer is the sponsor
p.000144: of the applicable clinical trial and for which an application or premarket notification seeking ap-
p.000144: proval, licensure, or clearance of the use being studied (which is not in- cluded in the labeling
p.000144: of the approved, licensed, or cleared drug product (in- cluding a biological product) or device product)
p.000144: has been filed or will be filed within 1 year with FDA, the deadline for submitting clinical trial
p.000144: results in- formation, as specified in sections 402(j)(3)(C) and 402(j)(3)(I) of the Public Health
p.000144: Service Act (42 U.S.C. 282(j)(3)(C) and 42 U.S.C. 282(j)(3)(I)) or
p.000144: § 11.48, as applicable, will be 30 calendar days after the earliest of the following events:
p.000144: (i) FDA approves, licenses, or clears the drug product (including a biologi- cal product) or device
p.000144: product for the use studied in the applicable clinical trial;
p.000144: (ii) FDA issues a letter that ends the regulatory review cycle for the applica- tion or submission but does
p.000144: not ap- prove, license, or clear the drug prod- uct (including a biological product) or device product
p.000144: for the use studied in the applicable clinical trial; or
p.000144: (iii) The application or premarket notification seeking approval, licen- sure, or clearance of the
p.000144: new use is withdrawn without resubmission for not less than 210 calendar days.
p.000144: (2) T o-year limitation. Notwith- standing the deadlines specified in paragraph (b)(1) of
p.000144: this section, the re- sponsible party must submit clinical trial results information specified in
p.000144: paragraph (b)(1) of this section not later than the date that is 2 years after the date that the
p.000144: certification was sub- mitted, except to the extent that para- graph (d) of this section applies.
p.000145: 145
p.000145:
p.000145:
p.000145:
p.000145:
p.000145:
p.000145:
p.000145:
p.000145:
p.000145: § 11.44
p.000145: (3) Additional requirements. If a re- sponsible party who is both the manu- facturer of the drug
p.000145: product (including a biological product) or device product studied in an applicable clinical trial and the
p.000145: sponsor of the applicable clin- ical trial submits a certification in ac- cordance with paragraph (b)(1)
p.000145: of this section, that responsible party must submit such a certification for each ap- plicable clinical
p.000145: trial that meets the following criteria:
p.000145: (i) The applicable clinical trial is re- quired to be submitted in an applica- tion or premarket
p.000145: notification seeking approval, licensure, or clearance of a new use; and
p.000145: (ii) The applicable clinical trial stud- ies the same drug product (including a biological product) or
p.000145: device product for the same use as studied in the ap- plicable clinical trial for which the ini- tial
p.000145: certification was submitted.
p.000145: (c) Delayed submission of results ith
p.000145: certification if seeking initial approval, li- censure, or clearance.—(1) General re- quirements. If,
p.000145: prior to the submission deadline specified under paragraph (a) of this section, a responsible party sub- mits a
p.000145: certification that an applicable clinical trial studies an FDA-regulated drug product (including a
p.000145: biological product) or device product that was not approved, licensed, or cleared by FDA for any use before the
p.000145: primary comple- tion date of the trial, and that the sponsor intends to continue with prod- uct
p.000145: development and is either seeking, or may at a future date seek, FDA ap- proval, licensure, or clearance
p.000145: of the drug product (including a biological product) or device product under study, the deadline for
p.000145: submitting clinical trial results information, as specified in § 11.48, will be 30 calendar days after the
p.000145: earlier of the date on which:
p.000145: (i) FDA approves, licenses, or clears
p.000145: the drug product (including a biologi- cal product) or device product for any use that is studied in
p.000145: the applicable clinical trial; or
p.000145: (ii) The marketing application or premarket notification is withdrawn without resubmission for not
p.000145: less than 210 calendar days.
p.000145: (2) T o-year limitation. Notwith- standing the deadlines established in paragraph (c)(1) of this
p.000145: section, the re- sponsible party must submit clinical
p.000145: 42 CFR Ch. I (10–1–16 Edition)
p.000145: trial results information specified in paragraph (c)(1) of this section not later than 2 years
p.000145: after the date on which the certification was submitted, except to the extent that paragraph (d) of this section
p.000145: applies.
p.000145: (d) Submitting partial results informa- tion. (1) If clinical trial results infor- mation specified in
p.000145: sections 402(j)(3)(C) and 402(j)(3)(I) of the Public Health Service Act (42 U.S.C. 282(j)(3)(C) and 42
p.000145: U.S.C. 282(j)(3)(I)) or § 11.48, as applica- ble, has not been collected for a sec- ondary outcome
p.000145: measure(s) or addi- tional adverse event information by the primary completion date, the re- sponsible
p.000145: party must submit the re- maining required clinical trial results information for secondary
p.000145: outcome measure(s) or additional adverse event information for that clinical trial by the following deadlines:
p.000145: (i) For secondary outcome meas- ure(s), by the later of:
p.000145: (A) One year after the date on which the final subject is examined or re- ceives an intervention for
...
p.000151: requirements of this subpart that are not waived upon appeal by the later of the original sub- mission
p.000151: deadline or 30 calendar days after the notice of the denial upon ap- peal is sent to the responsible party.
p.000151: (c) If a waiver is granted under para- graph (a) or (b) of this section:
p.000151: (1) The Director will include a nota- tion in the clinical trial record that specified elements of the
p.000151: requirements of this part have been waived.
p.000151: (2) The Secretary will notify, in writ- ing, the appropriate committees of Congress and provide an
p.000151: explanation for why the waiver was granted, not later than 30 calendar days after any waiver is granted.
p.000151: (d) A responsible party for an appli- cable clinical trial with a primary completion date before
p.000151: January 18, 2017 may request a waiver from any applica- ble requirement(s) for clinical trial re- sults
p.000151: information submission by sub- mitting a waiver request, as specified in section 402(j)(3)(H) of the
p.000151: Public Health Service Act (42 U.S.C. 282(j)(3)(H)).
p.000152: 152
p.000152:
p.000152:
p.000152:
p.000152:
p.000152:
p.000152:
p.000152:
p.000152: Public Health Service, HHS § 11.60
p.000152:
p.000152: Subpart D—Additional Submission of Clinical Trial Information
p.000152: § 11.60 What requirements apply to the voluntary submission of clinical trial information for clinical
p.000152: trials of FDA-regulated drug products (in- cluding biological products) and de- vice products?
p.000152: (a) If a responsible party voluntarily submits clinical trial information for a clinical trial described in
p.000152: paragraph (a)(1) of this section, the responsible party must meet the conditions speci- fied in paragraph
p.000152: (a)(2) of this section.
p.000152: (1) The requirements of paragraph (a) of this section apply to a clinical trial that was initiated before
p.000152: January 18, 2017 and has a primary completion date before January 18, 2017, and that is ei- ther:
p.000152: (i) A clinical trial of an FDA-regu- lated drug product (including a biologi- cal product) or device product
p.000152: that is not an applicable clinical trial, or
p.000152: (ii) An applicable clinical trial that is not otherwise required to submit clinical trial registration
p.000152: information.
p.000152: (2) If the responsible party for a clin- ical trial described in paragraph (a)(1) of this section
p.000152: voluntarily submits clinical trial registration information and/or clinical trial results informa- tion,
p.000152: the responsible party must com- ply with the following requirements:
p.000152: (i) The responsible party must sub- mit the information in paragraphs (b)(2)(i)(A), (B), or (C) of
p.000152: this section for the clinical trial being submitted voluntarily.
p.000152: (A) If the responsible party volun- tarily registers a clinical trial, the re- sponsible party must
p.000152: submit clinical trial registration information specified in section 402(j)(2)(A)(ii) of the Public Health
p.000152: Service Act (42 U.S.C. 282(j)(2)(A)(ii)).
p.000152: (B) If the responsible party volun- tarily submits clinical trial results in- formation for a
p.000152: clinical trial for which the clinical trial registration informa- tion specified in section 402(j)(2)(A)(ii)
p.000152: of the Public Health Service Act (42
p.000152: U.S.C. 282(j)(2)(A)(ii)) has not been sub- mitted, the responsible party must sub- mit the clinical trial results
p.000152: informa- tion specified in sections 402(j)(3)(C) and 402(j)(3)(I) of the Public Health
p.000152:
p.000152: Service Act (42 U.S.C. 282(j)(3)(C) and 42
p.000152: U.S.C. 282(j)(3)(I)).
p.000152: (C) If the responsible party both vol- untarily submits clinical trial registra- tion information and
p.000152: voluntarily sub- mits clinical trial results information, the responsible party must submit both clinical trial
p.000152: registration information specified in section 402(j)(2)(A)(ii) of the Public Health Service Act
p.000152: (42
p.000152: U.S.C. 282(j)(2)(A)(ii)) and clinical trial results information specified in sec- tions 402(j)(3)(C) and
p.000152: 402(j)(3)(I) of the Public Health Service Act (42 U.S.C. 282(j)(3)(C) and 42 U.S.C. 282(j)(3)(I)).
p.000152: (ii) If, on or after September 27, 2007, a manufacturer submits an application or premarket notification to
p.000152: FDA for approval, licensure, or clearance of a drug product (including a biological product) or device
p.000152: product under sec- tions 505, 510(k), 515, or 520(m) of the Federal Food, Drug, and Cosmetic Act (21
p.000152: U.S.C 355, 360(k), 360e, 360j(m)) or section 351 of the Public Health Service Act (42 U.S.C. 262) for the use
p.000152: studied in the clinical trial submitted under para- graph (a)(1) of this section, the respon- sible party specified in
p.000152: paragraph (a)(1) of this section must also submit the in- formation specified in paragraph (a)(2)(iii)
p.000152: of this section by the deadline specified in paragraph (a)(2)(iv)(B) of this section for any applicable
p.000152: clinical trial that has not been submitted to ClinicalTrials.gov and that meets the following criteria:
p.000152: (A) The applicable clinical trial is re- quired to be submitted to FDA under sections 505, 510(k), 515, or 520(m)
p.000152: of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355, 360(k), 360e, 360j(m)) or section 351 of the
p.000152: Public Health Service Act (42 U.S.C. 262) in an application or premarket notification for approval, li- censure,
p.000152: or clearance to market the drug product (including a biological product) or device product for
p.000152: the use studied in the clinical trial specified in paragraph (a)(1) of this section; and
p.000152: (B) The manufacturer of the drug product (including a biological prod- uct) or device product
p.000152: studied in the applicable clinical trial is also the re- sponsible party for the clinical trial
p.000152: specified in paragraph (a)(1) of this sec- tion.
p.000153: 153
p.000153:
p.000153:
p.000153:
p.000153:
p.000153:
p.000153:
p.000153:
p.000153:
p.000153: § 11.60
p.000153: (iii) Information to be submitted for clinical trials described in paragraph (a)(2)(ii) of this section:
p.000153: (A) If the clinical trial information voluntarily submitted for a clinical trial described in
p.000153: paragraph (a)(1) of this section consists only of the clin- ical trial registration information
p.000153: specified in section 402(j)(2)(A)(ii) of the Public Health Service Act (42
p.000153: U.S.C. 282(j)(2)(A)(ii)), the information to be submitted in accordance with paragraph (a)(2)(ii) of this
p.000153: section must consist, at minimum, of the clinical trial registration information specified in section
p.000153: 402(j)(2)(A)(ii) of the Public Health Service Act (42 U.S.C. 282(j)(2)(A)(ii)).
p.000153: (B) If the clinical trial information voluntarily submitted for a clinical trial described by paragraph
p.000153: (a)(1) of this section consists of the clinical trial results information specified in sections
p.000153: 402(j)(3)(C) and 402(j)(3)(I) of the Public Health Service Act (42
p.000153: U.S.C. 282(j)(3)(C) and 42 U.S.C. 282(j)(3)(I)), the information to be sub- mitted in accordance
p.000153: with paragraph (a)(2)(ii) of this section must consist of the clinical trial results information specified
...
p.000153: measure(s) required in section 402(j)(3)(C) of the Public Health Service Act (42 U.S.C.
p.000153: 282(j)(3)(C)) must be submitted by the later of the date that the clinical trial results information is
p.000153: voluntarily sub- mitted for the primary outcome meas- ure(s) or 1 year after the date on which the final
p.000153: subject was examined or re- ceived an intervention for the purposes of final collection of data for the sec-
p.000153: ondary outcome(s), whether the clin- ical trial was concluded according to the pre-specified protocol or was
p.000153: termi- nated.
p.000153: (2) If data collection for adverse
p.000153: event information continues after the primary completion date of the volun- tarily submitted clinical
p.000153: trial, any ad- verse event information collected after the primary completion date and sub- ject to the
p.000153: submission requirements in section 402(j)(3)(I) of the Public Health Service Act (42 U.S.C. 282(j)(3)(I))
p.000153: must be submitted by the later of the date that the clinical trial results informa- tion is voluntarily
p.000153: submitted for the primary outcome measure(s) or 1 year after the date of final collection of data
p.000153: for adverse event information, whether the clinical trial was con- cluded according to the
p.000153: pre-specified protocol or was terminated.
p.000153: (B) The clinical trial information
p.000153: specified in paragraph (a)(2)(iii) of this section must be submitted not later than the later of the
p.000153: date on which the application or premarket notification to FDA for approval, licensure, or clearance to
p.000153: market a drug product (in- cluding a biological product) or device product under section 351 of the Public Health
p.000153: Service Act (42 U.S.C. 262) or section 505, 510(k), 515, or 520(m) of the Federal Food, Drug, and
p.000153: Cosmetic Act (21 U.S.C. 355, 360(k), 360e, 360j(m)) for
p.000153: the use studied in the clinical trial specified under paragraph (a)(1) of this
p.000154: 154
p.000154:
p.000154:
p.000154:
p.000154:
p.000154:
p.000154:
p.000154:
p.000154: Public Health Service, HHS § 11.60
p.000154:
p.000154:
p.000154: section is submitted to FDA or the date on which the clinical trial infor- mation specified in
p.000154: paragraph (a)(2)(i) of this section for the clinical trial specified under paragraph (a)(1) of this
p.000154: section is submitted to ClinicalTrials.gov.
p.000154: (b) If a responsible party voluntarily submits clinical trial information for a clinical trial described in
p.000154: paragraph (b)(1) of this section, the responsible party must meet the conditions speci- fied in paragraph
p.000154: (b)(2) of this section.
p.000154: (1) The requirements of paragraph (b) of this section apply to a clinical trial that was initiated before
p.000154: January 18, 2017 and has a primary completion date on or after January 18, 2017, and that is either:
p.000154: (i) A clinical trial of an FDA-regu- lated drug product (including a biologi- cal product) or device product
p.000154: that is not an applicable clinical trial; or
p.000154: (ii) An applicable clinical trial that is not otherwise required to submit clinical trial registration
p.000154: information.
p.000154: (2) If the responsible party for a clin- ical trial described in paragraph (b)(1) of this section
p.000154: voluntarily submits clinical trial registration information and/or clinical trial results informa- tion,
p.000154: the responsible party must com- ply with the following requirements:
p.000154: (i) The responsible party must sub- mit the information in paragraph (b)(2)(i)(A), (B), or (C) of
p.000154: this section for the clinical trial being submitted voluntarily.
p.000154: (A) If the responsible party volun- tarily registers a clinical trial, the re- sponsible party must
p.000154: submit clinical trial registration information specified in section 402(j)(2)(A)(ii) of the Public Health
p.000154: Service Act (42 U.S.C. 282(j)(2)(A)(ii)).
p.000154: (B) If the responsible party volun- tarily submits clinical trial results in- formation for a
p.000154: clinical trial for which the clinical trial registration informa- tion specified in section 402(j)(2)(A)(ii)
p.000154: of the Public Health Service Act (42
p.000154: U.S.C. 282(j)(2)(A)(ii)) has not been sub- mitted, the responsible party must sub- mit the data elements
p.000154: specified in
p.000154: § 11.48, as well as the data elements listed below, as those data elements are defined in §
p.000154: 11.10(b) and apply to the clinical trial and the intervention(s) studied: Brief Title; Official Title; Brief
p.000154:
p.000154: Summary; Primary Purpose; Study De- sign; Study Phase, for a clinical trial of a drug product (including a
p.000154: biological product); Study Type; Pediatric Postmarket Surveillance of a Device Product; Primary
p.000154: Disease or Condition Being Studied in the Trial, or the Focus of the Study; Intervention
p.000154: Name(s), for each intervention studied; Other Intervention Name(s), for each intervention studied; Intervention
p.000154: De- scription, for each intervention stud- ied; Intervention Type, for each inter- vention studied; Device
p.000154: Product Not Approved or Cleared by U.S. FDA, if any studied intervention is a device product;
p.000154: Product Manufactured in and Exported from the U.S.; Studies a U.S. FDA-regulated Device Product; Studies a
p.000154: U.S. FDA-regulated Drug Product; Study Start Date; Primary Completion Date; Study Completion Date; Enroll-
p.000154: ment; Eligibility Criteria; Sex/Gender; Age Limits; Accepts Healthy Volun- teers; Overall Recruitment
p.000154: Status; Why Study Stopped; Availability of Ex- panded Access, if any studied interven- tion is an investigational
p.000154: drug product (including a biological product); Name of the Sponsor; Responsible Party, by Official Title;
p.000154: Facility Information, for each participating facility; Unique Protocol Identification Number; Sec-
p.000154: ondary ID; U.S. Food and Drug Admin- istration IND or IDE Number; Human Subjects Protection Review Board Sta- tus;
p.000154: Record Verification Date; and Re- sponsible Party Contact Information.
p.000154: (C) If the responsible party both vol-
p.000154: untarily submits clinical trial registra- tion information and voluntarily sub- mits clinical trial results
p.000154: information, the responsible party must submit both the clinical trial registration informa- tion specified in
p.000154: section 402(j)(2)(A)(ii) of the Public Health Service Act (42
p.000154: U.S.C. 282(j)(2)(A)(ii)) and the clinical trial results information specified in
p.000154: § 11.48.
p.000154: (ii) If, on or after September 27, 2007, a manufacturer submits an application or premarket notification to
p.000154: FDA for approval, licensure, or clearance of a drug product (including a biological product) or device
p.000154: product under sec- tion 505, 510(k), 515, or 520(m) of the Federal Food, Drug, and Cosmetic Act (21
p.000154: U.S.C. 355, 360(k), 360e, 360j(m)) or section 351 of the Public Health Service
p.000155: 155
p.000155:
p.000155:
p.000155:
p.000155:
p.000155:
p.000155:
p.000155:
p.000155:
p.000155: § 11.60
p.000155: Act (42 U.S.C. 262) for the use studied in the clinical trial submitted under para- graph (b)(1) of this section, the
p.000155: respon- sible party specified in paragraph (b)(1) of this section must also submit the in- formation specified
p.000155: in paragraph (b)(2)(iii) of this section by the deadline specified in paragraph (b)(2)(iv)(B) of this
p.000155: section for any applicable clinical trial that has not been submitted to ClinicalTrials.gov and that
p.000155: meets the following criteria:
p.000155: (A) The applicable clinical trial is re- quired to be submitted to FDA under section 505, 510(k), 515, or
p.000155: 520(m) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355, 360(k), 360e, 360j(m)) or section 351
p.000155: of the Public Health Service Act (42 U.S.C. 262) in an application or premarket notification for approval, li-
p.000155: censure, or clearance to market the drug product (including a biological product) or device
p.000155: product for the use studied in the clinical trial specified in paragraph (b)(1) of this section; and
p.000155: (B) The manufacturer of the drug product (including a biological prod- uct) or device product
p.000155: studied in the applicable clinical trial is also the re- sponsible party for the clinical trial
p.000155: specified in paragraph (b)(1) of this sec- tion.
p.000155: (iii) Information to be submitted for clinical trials described in paragraph (b)(2)(ii) of this section:
p.000155: (A) If the clinical trial information voluntarily submitted for a clinical trial described in
p.000155: paragraph (b)(1) of this section consists only of the clin- ical trial registration information
p.000155: specified in section 402(j)(2)(A)(ii) of the Public Health Service Act (42
p.000155: U.S.C. 282(j)(2)(A)(ii)), the information to be submitted in accordance with paragraph (b)(2)(ii) of this
p.000155: section must consist, at minimum, of the clinical trial registration information specified in section
p.000155: 402(j)(2)(A)(ii) of the Public Health Service Act (42 U.S.C. 282(j)(2)(A)(ii)).
p.000155: (B) If the clinical trial information voluntarily submitted for a clinical trial described by paragraph
p.000155: (b)(1) of this section consists of the clinical trial results information specified in
p.000155: § 11.60(b)(2)(i)(B), the information to be submitted in accordance with para- graph (b)(2)(ii) of
p.000155: this section must
p.000155: 42 CFR Ch. I (10–1–16 Edition)
p.000155: consist of the clinical trial results in- formation specified in § 11.60(b)(2)(i)(B).
p.000155: (C) If the clinical trial information voluntarily submitted for a clinical trial described by paragraph
...
p.000155: in § 11.48(a)(3) must be sub- mitted by the later of the date that the clinical trial results information is
p.000155: vol- untarily submitted for the primary outcome measure(s) or 1 year after the date on which the final subject
p.000155: was ex- amined or received an intervention for the purposes of final collection of data for the secondary
p.000155: outcome(s), whether the clinical trial was concluded accord- ing to the pre-specified protocol or was terminated.
p.000155: (2) If data collection for adverse
p.000155: event information continues after the primary completion date of the volun- tarily submitted clinical
p.000155: trial, any ad- verse event information collected after the primary completion date and sub- ject to the
p.000155: submission requirements in
p.000155: § 11.48(a)(4) must be submitted by the later of the date that the clinical trial results information is
p.000155: voluntarily sub- mitted for the primary outcome meas- ure(s) or 1 year after the date of final collection
p.000155: of data for adverse event in- formation, whether the clinical trial
p.000156: 156
p.000156:
p.000156:
p.000156:
p.000156:
p.000156:
p.000156:
p.000156:
p.000156: Public Health Service, HHS § 11.60
p.000156:
p.000156:
p.000156: was concluded according to the pre- specified protocol or was terminated.
p.000156: (B) The clinical trial information specified in paragraph (b)(2)(iii) of this section must be
p.000156: submitted not later than the later of the date on which the application or premarket notification to FDA for
p.000156: approval, licensure, or clearance to market a drug product (in- cluding a biological product) or device
p.000156: product under section 351 of the Public Health Service Act (42 U.S.C. 262) or section 505, 510(k), 515, or
p.000156: 520(m) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355, 360(k), 360e, 360j(m)) for the use
p.000156: studied in the clinical trial specified under paragraph (b)(1) of this section is submitted to FDA
p.000156: or the date on which the clinical trial infor- mation specified in paragraph (b)(2)(i) of this
p.000156: section for the clinical trial specified under paragraph (b)(1) of this section is
p.000156: submitted to ClinicalTrials.gov.
p.000156: (c) If a responsible party voluntarily submits clinical trial information for a clinical trial described in
p.000156: paragraph (c)(1) of this section, the responsible party must meet the conditions speci- fied in
p.000156: paragraph (c)(2) of this section.
p.000156: (1) The requirements of paragraph (c) of this section apply to a clinical trial that was initiated on or
p.000156: after January 18, 2017 and has a primary completion date on or after January 18, 2017, and that is
p.000156: either:
p.000156: (i) A clinical trial of an FDA-regu- lated drug product (including a biologi- cal product) or device product
p.000156: that is not an applicable clinical trial; or
p.000156: (ii) An applicable clinical trial that is not otherwise required to submit clinical trial registration
p.000156: information.
p.000156: (2) If the responsible party for a clin- ical trial described in paragraph (c)(1) of this section
p.000156: voluntarily submits clinical trial registration information and/or clinical trial results informa- tion,
p.000156: the responsible party must com- ply with the following requirements:
p.000156: (i) The responsible party must sub- mit the information in paragraph (c)(2)(i)(A), (B), or (C) of
p.000156: this section for the clinical trial being submitted voluntarily.
p.000156: (A) If the responsible party volun- tarily registers a clinical trial, the re- sponsible party must
p.000156: submit the clin-
p.000156:
p.000156: ical trial registration information specified in § 11.28(a).
p.000156: (B) If the responsible party volun- tarily submits clinical trial results in- formation for a
p.000156: clinical trial for which the clinical trial registration informa- tion specified in § 11.28(a) has not
p.000156: been submitted, the responsible party must submit the data elements specified in paragraph (b)(2)(i)(B) of
p.000156: this section.
p.000156: (C) If the responsible party both vol- untarily submits clinical trial registra- tion information and
p.000156: voluntarily sub- mits clinical trial results information, the responsible party must submit both the clinical
p.000156: trial registration informa- tion specified in § 11.28(a) and the clin- ical trial results information
p.000156: specified in § 11.48.
p.000156: (ii) If, on or after September 27, 2007, a manufacturer submits an application or premarket notification to
p.000156: FDA for approval, licensure, or clearance of a drug product (including a biological product) or device
p.000156: product under sec- tion 505, 510(k), 515, or 520(m) of the Federal Food, Drug, and Cosmetic Act (21
p.000156: U.S.C. 355, 360(k), 360e, 360j(m)) or section 351 of the Public Health Service Act (42 U.S.C. 262) for the use
p.000156: studied in the clinical trial submitted under para- graph (c)(1) of this section, the respon- sible party
p.000156: specified in paragraph (c)(1) of this section must also submit the in- formation specified in paragraph
p.000156: (c)(2)(iii) of this section by the deadline specified in paragraph (c)(2)(iv)(B) of this section for any
p.000156: applicable clinical trial that has not been submitted to ClinicalTrials.gov and that meets the following
p.000156: criteria:
p.000156: (A) The applicable clinical trial is re-
p.000156: quired to be submitted to FDA under section 505, 510(k), 515, or 520(m) of the Federal Food, Drug, and
p.000156: Cosmetic Act (21 U.S.C. 355, 360(k), 360e, 360j(m)) or
p.000156: section 351 of the Public Health Service Act (42 U.S.C. 262) in an application or premarket notification for
p.000156: approval, li- censure, or clearance to market the drug product (including a biological product) or
p.000156: device product for the use studied in the clinical trial specified in paragraph (c)(1) of this section; and
p.000156: (B) The manufacturer of the drug product (including a biological prod- uct) or device product
p.000156: studied in the applicable clinical trial is also the re- sponsible party for the clinical trial
p.000157: 157
p.000157:
p.000157:
p.000157:
p.000157:
p.000157:
p.000157:
p.000157:
p.000157:
p.000157: § 11.60
p.000157: specified in paragraph (c)(1) of this sec- tion.
p.000157: (iii) Information to be submitted for clinical trials described in paragraph (c)(2)(ii) of this section:
p.000157: (A) If the clinical trial information voluntarily submitted for a clinical trial described in
p.000157: paragraph (c)(1) of this section consists only of the clin- ical trial registration information
p.000157: specified in § 11.28(a), the information to be submitted in accordance with paragraph (c)(2)(ii) of this
p.000157: section must consist, at minimum, of the clinical trial registration information specified in § 11.28(a).
p.000157: (B) If the clinical trial information voluntarily submitted for a clinical trial described by paragraph
p.000157: (c)(1) of this section consists of the clinical trial results information specified in
p.000157: § 11.60(c)(2)(i)(B), the information to be submitted in accordance with para- graph (c)(2)(ii) of
p.000157: this section must consist of the clinical trial results in- formation specified in § 11.60(c)(2)(i)(B).
p.000157: (C) If the clinical trial information voluntarily submitted for a clinical trial described by paragraph
p.000157: (c)(1) of this section consists of both the clin- ical trial registration information specified in
p.000157: § 11.28(a) and the clinical trial results information specified in
...
p.000157: para- graph (c) of this section is not com- pleted by the primary completion date of the voluntarily
p.000157: submitted clinical trial, clinical trial results information for the secondary outcome measure(s) required
p.000157: in § 11.48(a)(3) must be sub- mitted by the later of the date that the clinical trial results information is
p.000157: vol- untarily submitted for the primary outcome measure(s) or 1 year after the date on which the final subject
p.000157: was ex-
p.000157: 42 CFR Ch. I (10–1–16 Edition)
p.000157: amined or received an intervention for the purposes of final collection of data for the secondary
p.000157: outcome(s), whether the clinical trial was concluded accord- ing to the pre-specified protocol or was terminated.
p.000157: (2) If data collection for adverse event information continues after the primary completion date of
p.000157: the volun- tarily submitted clinical trial, any ad- verse event information collected after the primary
p.000157: completion date and sub- ject to the submission requirements in
p.000157: § 11.48(a)(4) must be submitted by the later of the date that the clinical trial results information is
p.000157: voluntarily sub- mitted for the primary outcome meas- ure(s) or 1 year after the date of final collection
p.000157: of data for adverse events in- formation, whether the clinical trial was concluded according to the
p.000157: pre- specified protocol or was terminated.
p.000157: (B) The clinical trial information specified in paragraph (c)(2)(iii) of this section must be
p.000157: submitted not later than the later of the date on which the application or premarket notification to FDA for
p.000157: approval, licensure, or clearance to market a drug product (in- cluding a biological product) or device
p.000157: product under section 351 of the Public Health Service Act (42 U.S.C. 262) or section 505, 510(k), 515, or
p.000157: 520(m) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355, 360(k), 360e, 360j(m)) for the use
p.000157: studied in the clinical trial specified under paragraph (c)(1) of this section is submitted to FDA
p.000157: or the date on which the clinical trial infor- mation specified in paragraph (c)(2)(i) of this
p.000157: section for the clinical trial specified under paragraph (c)(1) of this section is
p.000157: submitted to ClinicalTrials.gov.
p.000157: (v) All submissions of clinical trial
p.000157: information under paragraph (c) of this section are subject to the applicable update and corrections
p.000157: requirements specified in § 11.64.
p.000157: (d) Statement to accompany applica- ble clinical trials submitted under paragraphs (a), (b), and
p.000157: (c) of this sec- tion. Each applicable clinical trial for which clinical trial information is sub- mitted
p.000157: under paragraphs (a), (b), and
p.000157: (c) of this section and posted on ClinicalTrials.gov will include the state- ment ‘‘This clinical
p.000157: trial information was submitted voluntarily under the
p.000158: 158
p.000158:
p.000158:
p.000158:
p.000158:
p.000158:
p.000158:
p.000158:
p.000158: Public Health Service, HHS § 11.64
p.000158:
p.000158:
p.000158: applicable law and, therefore, certain submission deadlines may not apply. (That is, clinical trial
p.000158: information for this applicable clinical trial was sub- mitted under section 402(j)(4)(A) of the Public
p.000158: Health Service Act and 42 CFR
p.000158: 11.60 and is not subject to the deadlines established by sections 402(j)(2) and (3) of the Public Health
p.000158: Service Act or 42 CFR 11.24 and 11.44.)’’
p.000158: § 11.62 What requirements apply to ap- plicable clinical trials for which submission of clinical trial
p.000158: informa- tion has been determined by the Di- rector to be necessary to protect the public health?
p.000158: (a) A responsible party who receives notification that the Director has de- termined that posting of
p.000158: clinical trial information for an applicable clinical trial described in paragraph (b) of this section is
p.000158: necessary to protect the pub- lic health must submit clinical trial in- formation as specified in paragraph (c) of
p.000158: this section.
p.000158: (b) An applicable clinical trial sub- ject to this section must be either:
p.000158: (1) An applicable clinical trial of an approved, licensed, or cleared drug product (including a
p.000158: biological prod- uct) or device product that has a pri- mary completion date on or after Sep- tember 27,
p.000158: 1997; or
p.000158: (2) An applicable clinical trial that is subject to registration under § 11.22(a) and studies a drug product
p.000158: (including a biological product) or device product that is unapproved, unlicensed, or uncleared,
p.000158: regardless of whether ap- proval, licensure, or clearance was, is, or will be sought, and that is not other-
p.000158: wise subject to results information submission in accordance with the reg- ulation.
p.000158: (c) Deadline for submission of clin- ical trial information:
p.000158: (1) General. Except as provided in paragraphs (c)(2) and (c)(3) of this sec- tion, a responsible party
p.000158: for an applica- ble clinical trial that is subject to this section must submit the clinical trial registration
p.000158: information specified in
p.000158: § 11.28(a) and the clinical trial results information specified in § 11.48(a) not later than 30
p.000158: calendar days after the submission date specified in the notifi- cation described in paragraph (a) of this
p.000158: section.
p.000158:
p.000158: (2) Exception. If a responsible party submits a certification consistent with
p.000158: § 11.44(b) or (c) not later than 30 cal- endar days after the submission date specified in the
p.000158: notification described in paragraph (a) of this section, the re- sponsible party must submit the clin- ical
p.000158: trial results information specified in § 11.48(a) not later than the deadline specified in § 11.44(b) or
p.000158: (c), as applica- ble.
p.000158: (3) If a responsible party submitted clinical trial registration information describing the applicable
...
p.000158: (B) Overall Recruitment Status must be updated not later than 30 calendar days after any change in
p.000158: overall re- cruitment status.
p.000158: (C) Primary Completion Date must be updated not later than 30 calendar days after the clinical trial
p.000158: reaches its actual primary completion date.
p.000158: (ii) The responsible party for an ap- plicable clinical trial, or for another
p.000159: 159
p.000159:
p.000159:
p.000159:
p.000159:
p.000159:
p.000159:
p.000159:
p.000159:
p.000159: § 11.64
p.000159: clinical trial for which registration in- formation was voluntarily submitted pursuant to § 11.60(c),
p.000159: if the clinical trial was initiated on or after January 18, 2017, must submit updates in ac-
p.000159: cordance with the following:
p.000159: (A) In general, changes to clinical trial registration information specified in § 11.28 must be updated not
p.000159: less than once every 12 months.
p.000159: (B) If the first human subject was not enrolled in the clinical trial at the time of registration, the
p.000159: Study Start Date data element must be updated not later than 30 calendar days after the first human subject is
p.000159: enrolled.
p.000159: (C) Intervention Name(s) must be up- dated to a non-proprietary name not later than 30 calendar days after a non-
p.000159: proprietary name is established for any intervention included in the Interven- tion Name(s) data element.
p.000159: (D) Availability of expanded access:
p.000159: (1) If expanded access to an investiga- tional drug product (including a bio- logical product) becomes
p.000159: available after an applicable clinical trial of that product has been registered, the re- sponsible party,
p.000159: if both the manufac- turer of the investigational drug prod- uct (including a biological product) and the
p.000159: sponsor of the applicable clinical trial, must, not later than 30 calendar days after expanded access
p.000159: becomes available, update the Availability of Expanded Access data element for that applicable clinical trial
p.000159: and, unless an expanded access record has already been created as required by
p.000159: § 11.28(a)(2)(ii)(H), submit the data ele-
p.000159: ments in accordance with § 11.28(c) to create an expanded access record.
p.000159: (2) No later than 30 calendar days after the date on which the responsible party receives an NCT number
p.000159: for an expanded access record created as re- quired by § 11.28(a)(2)(ii)(H), the respon- sible party must
p.000159: update the Avail- ability of Expanded Access data ele- ment by entering the NCT number in the
p.000159: clinical trial record for the applica- ble clinical trial.
p.000159: (E) Expanded access record:
p.000159: (1) Expanded Access Status, under
p.000159: § 11.28(c)(2)(iv), must be updated not later than 30 calendar days after a change in the
p.000159: availability of expanded access to an investigational drug prod- uct (including a biological product)
p.000159: 42 CFR Ch. I (10–1–16 Edition)
p.000159: under section 561 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360bbb).
p.000159: (2) Expanded Access Type, under
p.000159: § 11.28(c)(1)(x), must be updated not later than 30 calendar days after a change in the type(s)
p.000159: of expanded ac- cess available for an investigational drug product (including a biological product)
p.000159: under section 561 of the Fed- eral Food, Drug, and Cosmetic Act (21
p.000159: U.S.C. 360bbb).
p.000159: (F) Overall Recruitment Status must be updated not later than 30 calendar days after any change in
p.000159: overall re- cruitment status. If, at any time, Over- all Recruitment Status is changed to ‘‘suspended,’’
p.000159: ‘‘terminated,’’ or ‘‘with- drawn,’’ the responsible party must also submit the Why Study Stopped
p.000159: data element.
p.000159: (G) Individual Site Status must be updated not later than 30 calendar days after a change in status for any
p.000159: indi- vidual site.
p.000159: (H) Human Subjects Protection Re- view Board Status must be updated not later than 30 calendar days after
p.000159: a change in status.
p.000159: (I) Primary Completion Date must be updated not later than 30 calendar days after the clinical trial reaches its
p.000159: ac- tual primary completion date. At the time, the date is changed to ‘‘actual,’’ and the Enrollment
p.000159: data element specifying the actual number of par- ticipants enrolled must be submitted.
p.000159: (J) Study Completion Date must be updated not later than 30 calendar days after the clinical trial reaches
p.000159: its ac- tual study completion date.
p.000159: (K) Responsible Party, by Official Title must be updated not later than 30 calendar days after a change in
p.000159: the re- sponsible party or the official title of the responsible party.
...
p.000161: clinical trial registra- tion information, or 25 calendar days for clinical trial results information, to
p.000161: correct or address such errors.
p.000161: (ii) A responsible party’s obligation to correct or address errors as specified in paragraph (b)(2) of this
p.000161: section ends on the date on which all required clin- ical trial results information has been submitted
p.000161: as specified in sections
p.000161: 42 CFR Ch. I (10–1–16 Edition)
p.000161: 402(j)(3)(C) and 402(j)(3)(I) of the Public Health Service Act (42 U.S.C. 282(j)(3)(C) and
p.000161: 42 U.S.C. 282(j)(3)(I)) or
p.000161: § 11.48, as applicable, and corrections have been made or addressed in re- sponse to any
p.000161: electronic notice re- ceived under § 11.64(b)(1). If no clinical trial results information is required to
p.000161: be submitted, a responsible party’s ob- ligation to correct or address errors ends on the date on
p.000161: which all required clinical trial registration information has been submitted as specified in sec- tion
p.000161: 402(j)(2)(A)(ii) of the Public Health Service Act (42 U.S.C. 282(j)(2)(A)(ii)) or
p.000161: § 11.28, as applicable, and corrections
p.000161: have been made or addressed in re- sponse to any electronic notice re- ceived under §
p.000161: 11.64(b)(1).
p.000161: (3) Compliance with the quality con- trol review process, including the re- quirements of this section,
p.000161: does not constitute a legal defense to enforce- ment pursuant to section 301(jj) of the Federal Food,
p.000161: Drug and Cosmetic Act (21 U.S.C. 331(jj)), section 303(f)(3) of the Federal Food, Drug and Cosmetic Act (21
p.000161: U.S.C. 333(f)(3)), or any other Fed- eral law.
p.000161:
p.000161: Subpart E—Potential Legal Con- sequences of Non-Compli- ance
p.000161: § 11.66 What are potential legal con- sequences of not complying with the requirements of this part?
p.000161: (a) Civil or criminal judicial actions. Failure to comply with the require- ments of this part,
p.000161: issued under section 402(j) of the Public Health Service Act (42 U.S.C. 282(j)), is a prohibited act
p.000161: under one or more provisions of section 301(jj) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 331(jj)):
p.000161: (1) Failure to submit the certifi-
p.000161: cation required by section 402(j)(5)(B) of the Public Health Service (42 U.S.C. 282(j)(5)(B)) that all
p.000161: applicable require- ments of section 402(j) have been met, or knowingly submitting a false cer- tification
p.000161: under section 402(j)(5)(B), is a prohibited act under section 301(jj)(1) of the Federal Food, Drug, and
p.000161: Cos- metic Act.
p.000161: (2) Failure to submit clinical trial in-
p.000161: formation required under section 402(j) of the Public Health Service Act is a prohibited act under
p.000161: section 301(jj)(2)
p.000162: 162
p.000162:
p.000162:
p.000162:
p.000162:
p.000162:
p.000162:
p.000162:
p.000162: Public Health Service, HHS § 11.66
p.000162:
p.000162:
p.000162: of the Federal Food, Drug, and Cos- metic Act.
p.000162: (3) Submission of clinical trial infor- mation under section 402(j) that is false or misleading in any
p.000162: particular is a prohibited act under section 301(jj)(3) of the Federal Food, Drug, and Cos- metic
p.000162: Act.
p.000162: (b) Civil monetary penalty actions. Any person who violates section 301(jj) of the Federal Food, Drug, and
p.000162: Cosmetic Act is subject to civil monetary pen- alties under section 303(f)(3) of the Fed- eral Food, Drug,
p.000162: and Cosmetic Act (21
p.000162: U.S.C. 333(f)(3)).
p.000162: (c) Grant funding actions. Under sec- tion 402(j)(5)(A) of the Public Health Service Act (42 U.S.C.
p.000162: 282(j)(5)(A)), if an applicable clinical trial is funded in whole or part by the Department of
p.000162: Health and Human Services, any re-
p.000162:
p.000162: quired grant or progress report forms must include a certification that the responsible party has made all
p.000162: required registration and results submissions. If it is not verified that the required reg- istration and results
p.000162: clinical trial in- formation for each applicable clinical trial for which a grantee is the respon- sible party
p.000162: has been submitted, any re- maining funding for a grant or funding for a future grant to such grantee will not
p.000162: be released. If the head of an HHS agency verifies that a grantee has not submitted such required
p.000162: clinical trial information, the agency head will pro- vide notice to the grantee of the non- compliance
p.000162: and allow the grantee 30 days to correct the non-compliance and submit the required clinical trial infor-
p.000162: mation.
p.000162:
p.000162:
p.000162:
p.000162:
p.000162:
p.000162:
p.000162:
p.000162:
p.000162:
p.000162:
p.000162:
p.000162:
p.000162:
p.000162:
p.000162:
p.000162:
p.000162:
p.000162:
p.000162:
p.000162:
p.000162:
p.000162:
p.000162:
p.000162:
p.000162:
p.000162:
p.000162:
p.000162:
p.000162:
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Health / Healthy People
Searching for indicator healthyXvolunteers:
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p.000139: (K) Other Intervention Name(s), for each intervention studied;
p.000139: (L) Intervention Description, for each intervention studied;
p.000139: (M) Intervention Type, for each intervention studied;
p.000139: (N) Studies a U.S. FDA-regulated De- vice Product;
p.000139: (O) Studies a U.S. FDA-regulated Drug Product;
p.000139: (P) Device Product Not Approved or Cleared by U.S. FDA, if any studied intervention is a device product;
p.000139: (Q) Post Prior to U.S. FDA Approval or Clearance, for an applicable device clinical trial that studies
p.000139: at least one device product not previously approved or cleared by the U.S. FDA;
p.000139: (R) Product Manufactured in and Ex- ported from the U.S., if the entry for
p.000139: U.S. Food and Drug Administration IND or IDE Number in
p.000139: § 11.28(a)(2)(iv)(C) indicates that there is no IND or IDE for the clinical trial, and the entry(ies) for
p.000139: Facility Informa- tion in § 11.28(a)(2)(iii)(C) include no fa- cility locations in the United States or its
p.000139: territories;
p.000139: (S) Study Start Date;
p.000139: (T) Primary Completion Date;
p.000139: (U) Study Completion Date;
p.000139: (V) Enrollment;
p.000139: (W) Primary Outcome Measure Infor- mation, for each primary outcome measure; and
p.000139: (X) Secondary Outcome Measure In- formation, for each secondary outcome measure.
p.000139: (ii) Recruitment information:
p.000139: (A) Eligibility Criteria;
p.000139: (B) Sex/Gender;
p.000139: (C) Age Limits;
p.000139: (D) Accepts Healthy Volunteers;
p.000139: (E) Overall Recruitment Status;
p.000139: (F) Why Study Stopped;
p.000139: (G) Individual Site Status; and
p.000139: (H) Availability of Expanded Access. If expanded access is available for an investigational drug product
p.000139: (including a biological product), an expanded ac- cess record must be submitted in ac- cordance with §
p.000139: 11.28(c), unless an ex- panded access record was submitted
p.000140: 140
p.000140:
p.000140:
p.000140:
p.000140:
p.000140:
p.000140:
p.000140:
p.000140: Public Health Service, HHS § 11.28
p.000140:
p.000140:
p.000140: previously in accordance with that pro- vision.
p.000140: (iii) Location and contact informa- tion:
p.000140: (A) Name of the Sponsor;
p.000140: (B) Responsible Party, by Official Title; and
p.000140: (C) Facility Information.
p.000140: (iv) Administrative data:
p.000140: (A) Unique Protocol Identification Number;
p.000140: (B) Secondary ID;
p.000140: (C) U.S. Food and Drug Administra- tion IND or IDE Number;
p.000140: (D) Human Subjects Protection Re- view Board Status;
p.000140: (E) Record Verification Date; and
p.000140: (F) Responsible Party Contact Infor- mation.
p.000140: (b) Pediatric postmarket surveillance of a device product that is not a clin- ical trial. For
...
Searching for indicator volunteers:
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p.000136: (19) Primary Outcome Measure Informa- tion means a description of each pri- mary outcome measure, to include
p.000136: the following information:
p.000136: (i) Name of the specific primary out- come measure;
p.000136: (ii) Description of the metric used to characterize the specific primary out- come measure; and
p.000136: (iii) Time point(s) at which the meas- urement is assessed for the specific metric used.
p.000136: (20) Secondary Outcome Measure Infor- mation means a description of each sec- ondary outcome measure, to
p.000136: include the following information:
p.000136: (i) Name of the specific secondary outcome measure;
p.000136: (ii) Description of the metric used to characterize the specific secondary outcome measure; and
p.000136: (iii) Time point(s) at which the meas- urement is assessed for the specific metric used.
p.000136: (21) Eligibility Criteria means a limited list of criteria for selection of human subjects to participate in
p.000136: the clinical trial, provided in terms of inclusion and exclusion criteria and suitable for assisting
p.000136: potential human subjects in identifying clinical trials of interest.
p.000136: (22) Sex/Gender means the sex and, if applicable, gender of the human sub- jects who may participate in
p.000136: the clin- ical trial.
p.000136: (23) Age Limits means the minimum and maximum age of human subjects who may participate in the
p.000136: clinical trial, provided in relevant units of time.
p.000136: (24) Accepts Healthy Volunteers means that human subjects who do not have a disease or condition, or related
p.000136: condi- tions or symptoms, under study in the clinical trial are permitted to partici- pate in the clinical
p.000136: trial.
p.000136: (25) Overall Recruitment Status means the recruitment status for the clinical trial as a whole, based on the
p.000136: status of the individual sites. If at least one fa- cility in a multi-site clinical trial has an
p.000136: individual site status of ‘‘recruit- ing,’’ then the overall recruitment sta- tus for the trial must be
p.000136: ‘‘recruiting.’’
p.000136: (26) Why Study Stopped means, for a clinical trial that is suspended or ter- minated or withdrawn
p.000136: prior to its planned completion as anticipated by the protocol, a brief explanation of the
p.000136:
p.000136: reason(s) why the clinical trial was stopped.
p.000136: (27) Individual Site Status means the recruitment status of each partici- pating facility in a
p.000136: clinical trial.
p.000136: (28) Availability of Expanded Access means, for an applicable drug clinical trial of a drug product
p.000136: (including a bio- logical product) that is not an ap- proved drug product (including a bio- logical
p.000136: product), and for which the re- sponsible party is both the manufac- turer of the drug product
p.000136: (including a biological product) and the sponsor of the applicable clinical trial:
...
p.000150: results of the clin- ical trial at a scientific meeting or any
p.000150:
p.000150: other public or private forum or to publish in a scientific or academic journal information
p.000150: concerning the re- sults of the clinical trial
p.000150: (7) Additional clinical trial results infor- mation for applicable device clinical trials of unapproved or
p.000150: uncleared device prod- ucts. (i) For an applicable device clin- ical trial of an unapproved or uncleared device
p.000150: product and for which clinical trial registration information has not been posted publicly on
p.000150: Clinical Trials.gov by the Director in accord- ance with § 11.35(b)(2)(i), the responsible party must provide
p.000150: the following data elements, as the data elements are de- fined in § 11.10(b): Brief Title; Official
p.000150: Title; Brief Summary; Primary Pur- pose; Study Design; Study Type; Pri- mary Disease or Condition Being
p.000150: Stud- ied in the Trial, or the Focus of the Study; Intervention Name(s); Other Intervention Name(s);
p.000150: Intervention De- scription; Intervention Type; Device Product Not Approved or Cleared by
p.000150: U.S. FDA, if any studied intervention is a device product; Study Start Date; Primary Completion Date; Study
p.000150: Com- pletion Date, Enrollment; Primary Outcome Measure Information; Sec- ondary Outcome Measure
p.000150: Information; Eligibility Criteria; Sex/Gender; Age Limits; Accepts Healthy Volunteers; Overall
p.000150: Recruitment Status; Why Study Stopped; Name of the Sponsor; Responsible Party, by Official Title;
p.000150: Facility Name and Facility Location, for each participating facility in a clin- ical trial; Unique Protocol
p.000150: Identifica- tion Number; Secondary ID; Human Subjects Protection Review Board Sta- tus; and Record Verification
p.000150: Date.
p.000150: (ii) The responsible party shall sub-
p.000150: mit all the results information speci- fied in paragraph (a)(7)(i) and must sub- mit an affirmation that any
p.000150: informa- tion previously submitted to ClinicalTrials.gov for the data elements listed in
p.000150: paragraph (a)(7)(i) of this sec- tion have been updated in accordance with § 11.64(a) and are to be included
p.000150: as clinical trial results information.
p.000150: (b) Pediatric postmarket surveillance of
p.000150: a device product that is not a clinical trial. For each pediatric postmarket surveillance of a
p.000150: device product that is not a clinical trial, the responsible party must submit a copy of any final
p.000150: report that is submitted to FDA as
p.000151: 151
p.000151:
p.000151:
p.000151:
p.000151:
p.000151:
p.000151:
p.000151:
p.000151:
p.000151: § 11.52
p.000151: specified in 21 CFR 822.38. The respon- sible party may redact names, address- es, and other personally
p.000151: identifiable in- formation or commercial confidential information contained in the final re- port prior to
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Health / substance use
Searching for indicator substance use:
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p.000134: ‘‘secondary outcome’’ has the same meaning as secondary outcome meas- ure.
p.000134: Secretary means the Secretary of
p.000134: Health and Human Services or any other official(s) to whom the Secretary delegates the authority
p.000134: contained in section 402(j) of the Public Health Service Act (42 U.S.C. 282(j)).
p.000134: Serious adverse event means an ad- verse event that results in any of the following outcomes:
p.000134: Death, a life- threatening adverse event as defined in 21 CFR 312.32, inpatient hospitalization or prolongation
p.000134: of existing hospitaliza- tion, a persistent or significant inca- pacity or substantial disruption of the
p.000134: ability to conduct normal life func- tions, or a congenital anomaly/birth defect. Important medical
p.000134: events that may not result in death, be life-threat- ening, or require hospitalization may be considered serious
p.000134: when, based upon appropriate medical judgment, they may jeopardize the human subject and may require
p.000134: medical or surgical inter- vention to prevent one of the outcomes listed in this definition. Examples of such
p.000134: medical events include allergic bronchospasm requiring intensive treatment in an emergency room
p.000134: or at home, blood dyscrasias or convulsions that do not result in inpatient hos- pitalization, or
p.000134: the development of a substance use disorder.
p.000134: Sponsor means either a ‘‘sponsor’’ or
p.000134: ‘‘sponsor-investigator,’’ as each is de- fined in 21 CFR 50.3.
p.000134: Study completion date means, for a clinical trial, the date the final subject was examined or received an
p.000134: interven- tion for purposes of final collection of data for the primary and secondary outcome
p.000134: measures and adverse events
p.000134:
p.000134: (e.g., last subject’s last visit), whether the clinical trial concluded according to the pre-specified
p.000134: protocol or was ter- minated.
p.000134: U.S. FDA-regulated device product means, for purposes of this part, a de- vice product subject to
p.000134: section 510(k), 515, 520(m), or 522 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360(k),
p.000134: 21 U.S.C. 360e, 21 U.S.C. 360j(m), 21 U.S.C. 360l).
p.000134: U.S. FDA-regulated drug product means, for purposes of this part, a drug product subject to section
p.000134: 505 of the Federal Food, Drug, and Cosmetic Act or a biological product subject to sec- tion 351 of the
p.000134: Public Health Service Act (21 U.S.C. 355, 42 U.S.C. 262) .
p.000134: (b) The following definitions apply to data elements of clinical trial informa- tion referenced in this part, unless
p.000134: oth- erwise specified:
p.000134: (1) Brief Title means a short title of the clinical trial written in language intended for the lay
p.000134: public, including any acronym or abbreviation used pub- licly to identify the clinical trial.
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Social / Access to Social Goods
Searching for indicator access:
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p.000130: U.S. Food and Drug Adminstration (FDA), under section 522 of the Federal Food, Drug, and Cosmetic
p.000130: Act (21
p.000130: U.S.C. 3601), orders to conduct the pedi- atric postmarket surveillance of a de- vice product.
p.000130: (1) Determination of sponsor. For pur- poses of this part, each applicable clin- ical trial or other clinical
p.000130: trial must have one sponsor.
p.000130: (i) When an applicable clinical trial or other clinical trial is conducted under an investigational
p.000130: new drug ap- plication (IND) or investigational de- vice exemption (IDE), the IND or IDE holder will be
p.000130: considered the sponsor.
p.000130: (ii) When an applicable clinical trial or other clinical trial is not conducted under an IND or IDE, the
p.000130: single person or entity who initiates the trial, by preparing and/or planning the trial, and who
p.000130: has authority and control over the trial, will be considered the spon- sor.
p.000130: (2) Designation of a principal investi- gator as the responsible party.
p.000130: (i) The sponsor may designate a prin- cipal investigator as the responsible party if such principal
p.000130: investigator meets all of the following require- ments:
p.000130: (A) Is responsible for conducting the trial;
p.000130: (B) Has access to and control over the data from the trial;
p.000130: (C) Has the right to publish the re- sults of the trial; and
p.000130: (D) Has the ability to meet all of the requirements for submitting and up- dating clinical trial
p.000130: information as specified in this part.
p.000131: 131
p.000131:
p.000131:
p.000131:
p.000131:
p.000131:
p.000131:
p.000131:
p.000131:
p.000131: § 11.6
p.000131: (ii) With regard to an applicable clin- ical trial or other clinical trial, a des- ignation by the sponsor
p.000131: under para- graph (c)(2)(i) of this section shall con- sist of the sponsor obtaining from the principal
p.000131: investigator an acknowledg- ment of the principal investigator’s re- sponsibilities under this part as respon- sible
p.000131: party, and the principal investi- gator acknowledging the designation as responsible party to the
p.000131: Director in the format specified at https:// prsinfo.clinicaltrials.gov.
p.000131: (3) Withdra al of the designation of a principal investigator as the responsible party.
p.000131: In the event that a principal investi- gator who has been designated the re- sponsible party no longer
p.000131: meets or is no longer able to meet all the require- ments for being so designated under paragraph
p.000131: (c)(2)(i) of this section, the sponsor must withdraw the designation in the format specified at
p.000131: https:// prsinfo.clinicaltrials.gov, at which time the sponsor will be considered the re- sponsible party
...
p.000131: The clinical trial information sub- mitted by a responsible party under this part shall not
p.000131: be false or mis- leading in any particular. A responsible party who submits false and/or mis- leading
p.000131: information is subject to civil monetary penalties and/or other civil or criminal remedies available
p.000131: under
p.000131: U.S. law.
p.000131: § 11.8 In what format must clinical trial information be submitted?
p.000131: Information submitted under this part must be submitted electronically to ClinicalTrials.gov, in the
p.000131: format specified at https:// prsinfo.clinicaltrials.gov.
p.000131: § 11.10 What definitions apply to this part?
p.000131: (a) The following definitions apply to terms used in this part:
p.000131: Adverse event means any untoward or unfavorable medical occurrence in a human subject, including any
p.000131: abnor-
p.000131: 42 CFR Ch. I (10–1–16 Edition)
p.000131: mal sign (for example, abnormal phys- ical exam or laboratory finding), symp- tom, or disease, temporally
p.000131: associated with the subject’s participation in the research, whether or not considered re- lated to the
p.000131: subject’s participation in the research. See also the definition of ‘‘serious adverse event.’’
p.000131: Applicable clinical trial means an ap- plicable device clinical trial or an ap- plicable drug clinical
p.000131: trial. Expanded access use under section 561 of the Fed- eral Food, Drug, and Cosmetic Act (21
p.000131: U.S.C. 360bbb) is not an applicable clin- ical trial.
p.000131: Applicable device clinical trial means:
p.000131: (1) A prospective clinical study of health outcomes comparing an inter- vention with a device product
p.000131: subject to section 510(k), 515, or 520(m) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
p.000131: 360(k), 21 U.S.C. 360e, 21
p.000131: U.S.C. 360j(m)) against a control in human subjects (other than a small clinical trial to
p.000131: determine the feasi- bility of a device product, or a clinical trial to test prototype device products
p.000131: where the primary outcome measure relates to feasibility and not to health outcomes);
p.000131: (2) A pediatric postmarket surveil- lance of a device product as required under section 522 of the
p.000131: Federal Food, Drug, and Cosmetic Act (21 U.S.C. 3601); or
p.000131: (3) A clinical trial of a combination product with a device primary mode of action under 21 CFR part 3,
p.000131: provided that it meets all other criteria of the definition under this part.
p.000131: Applicable drug clinical trial means a controlled clinical investigation, other than a phase 1 clinical
p.000131: investigation, of a drug product subject to section 505 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
...
p.000133: part 50 and/or 45 CFR part 46, as applicable. For the purposes of this part, potential subjects who are screened
p.000133: for the purpose of determining eligibility for a trial, but do not par- ticipate in the trial, are not
p.000133: considered enrolled, unless otherwise specified by the protocol.
p.000133: Human subjects protection revie board means an institutional review board (IRB) as defined in 21 CFR
p.000133: 50.3 or 45 CFR 46.102, as applicable, that is re- sponsible for assuring the protection of the rights,
p.000133: safety, and well-being of human subjects involved in a clinical trial and is adequately constituted to
p.000133: provide assurance of that protection. An IRB may also be known as an ‘‘independent ethics
p.000133: committee.’’
p.000133: Interventional means, with respect to a clinical study or a clinical investiga- tion, that participants are
p.000133: assigned prospectively to an intervention or interventions according to a protocol to evaluate the
p.000133: effect of the interven- tion(s) on biomedical or other health- related outcomes.
p.000133: Investigational Device Exemption (IDE) has the meaning given in 21 CFR part 812.
p.000133: Investigational Ne Drug Application (IND) has the meaning given in 21 CFR 312.3.
p.000133: NCT number means the unique identi- fication code assigned to each record in ClinicalTrials.gov, including a record
p.000133: for an applicable clinical trial, a clinical trial, or an expanded access program.
p.000133: Ongoing means, with respect to a clinical trial of a drug product (includ- ing a biological product) or
p.000133: a device product and to a date, that one or more human subjects is enrolled in the clin- ical trial, and the
p.000133: date is before the primary completion date of the clinical trial. With respect to a pediatric
p.000133: postmarket surveillance of a device product, ongoing means a date between the date on which FDA approves
p.000133: the plan for conducting the surveillance and the date on which the final report is submitted to FDA.
p.000133: Outcome measure means a pre-speci-
p.000133: fied measurement that will be used to
p.000133: 42 CFR Ch. I (10–1–16 Edition)
p.000133: determine the effect of an experi- mental variable on the human sub- ject(s) in a clinical
p.000133: trial. See also the definitions of ‘‘primary outcome meas- ure’’ and ‘‘secondary outcome meas- ure.’’
p.000133: Pediatric postmarket surveillance of a device product means the active, sys- tematic, scientifically
p.000133: valid collection, analysis, and interpretation of data or other information conducted under sec- tion 522 of the
p.000133: Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360l) about a marketed device product that is ex-
p.000133: pected to have significant use in pa- tients who are 21 years of age or young- er at the time of diagnosis
p.000133: or treat- ment. A pediatric postmarket surveil- lance of a device product may be, but is not always, a clinical
p.000133: trial.
p.000133: Primary completion date means, for
p.000133: purposes of this part, ‘‘completion date.’’ See the definition of ‘‘comple- tion date.’’
p.000133: Primary outcome measure means the outcome measure(s) of greatest impor- tance specified in the protocol,
p.000133: usually the one(s) used in the power calcula- tion. Most clinical trials have one pri- mary outcome
p.000133: measure, but a clinical trial may have more than one. For pur- poses of this part, ‘‘primary outcome’’ has the
p.000133: same meaning as primary out- come measure.
p.000133: Principal investigator means the indi- vidual who is responsible for the over- all scientific and technical
p.000133: direction of the study.
p.000133: Protocol means the written descrip- tion of the clinical trial, including ob- jective(s), design, and
p.000133: methods. It may also include relevant scientific back- ground and statistical considerations.
p.000133: Responsible party means, with respect to a clinical trial, the sponsor of the clinical trial, as defined in
p.000133: 21 CFR 50.3; or the principal investigator of such clinical trial if so designated by a spon- sor, grantee,
p.000133: contractor, or awardee, so long as the principal investigator is re- sponsible for conducting the trial, has
p.000133: access to and control over the data from the clinical trial, has the right to publish the results of the
p.000133: trial, and has the ability to meet all of the require- ments under this part for the submis- sion of
p.000133: clinical trial information. For a pediatric postmarket surveillance of a device product that is not a
p.000133: clinical
p.000134: 134
p.000134:
p.000134:
p.000134:
p.000134:
p.000134:
p.000134:
p.000134:
p.000134: Public Health Service, HHS § 11.10
p.000134:
p.000134:
p.000134: trial, the responsible party is the enti- ty who FDA orders to conduct the pedi- atric postmarket
p.000134: surveillance of the device product.
p.000134: Secondary outcome measure means an outcome measure that is of lesser im- portance than a primary
p.000134: outcome measure, but is part of a pre-specified analysis plan for evaluating the effects of the intervention
p.000134: or interventions under investigation in a clinical trial and is not specified as an exploratory or other
p.000134: measure. A clinical trial may have more than one secondary outcome measure. For purposes of this part,
p.000134: ‘‘secondary outcome’’ has the same meaning as secondary outcome meas- ure.
p.000134: Secretary means the Secretary of
p.000134: Health and Human Services or any other official(s) to whom the Secretary delegates the authority
p.000134: contained in section 402(j) of the Public Health Service Act (42 U.S.C. 282(j)).
p.000134: Serious adverse event means an ad- verse event that results in any of the following outcomes:
...
p.000136: (22) Sex/Gender means the sex and, if applicable, gender of the human sub- jects who may participate in
p.000136: the clin- ical trial.
p.000136: (23) Age Limits means the minimum and maximum age of human subjects who may participate in the
p.000136: clinical trial, provided in relevant units of time.
p.000136: (24) Accepts Healthy Volunteers means that human subjects who do not have a disease or condition, or related
p.000136: condi- tions or symptoms, under study in the clinical trial are permitted to partici- pate in the clinical
p.000136: trial.
p.000136: (25) Overall Recruitment Status means the recruitment status for the clinical trial as a whole, based on the
p.000136: status of the individual sites. If at least one fa- cility in a multi-site clinical trial has an
p.000136: individual site status of ‘‘recruit- ing,’’ then the overall recruitment sta- tus for the trial must be
p.000136: ‘‘recruiting.’’
p.000136: (26) Why Study Stopped means, for a clinical trial that is suspended or ter- minated or withdrawn
p.000136: prior to its planned completion as anticipated by the protocol, a brief explanation of the
p.000136:
p.000136: reason(s) why the clinical trial was stopped.
p.000136: (27) Individual Site Status means the recruitment status of each partici- pating facility in a
p.000136: clinical trial.
p.000136: (28) Availability of Expanded Access means, for an applicable drug clinical trial of a drug product
p.000136: (including a bio- logical product) that is not an ap- proved drug product (including a bio- logical
p.000136: product), and for which the re- sponsible party is both the manufac- turer of the drug product
p.000136: (including a biological product) and the sponsor of the applicable clinical trial:
p.000136: (i) An indication of whether there is expanded access to the investigational drug product (including a
p.000136: biological product) under section 561 of the Fed- eral Food, Drug, and Cosmetic Act (21
p.000136: U.S.C. 360bbb) for those individuals who do not qualify for enrollment in the applicable clinical
p.000136: trial, under one or more of the following types of ex- panded access programs: for individual patients,
p.000136: including for emergency use, as specified in 21 CFR 312.310; for inter- mediate-size patient populations, as
p.000136: specified in 21 CFR 312.315; or under a treatment IND or treatment protocol, as specified in 21 CFR 312.320;
p.000136: and
p.000136: (ii) If expanded access is available under section 561 of the Federal Food, Drug, and Cosmetic
p.000136: Act (21 U.S.C. 360bbb), the NCT number of the ex- panded access record.
p.000136: (29) Name of the Sponsor means the name of the entity or individual who is the sponsor of the clinical
p.000136: trial, as de- fined in this part.
p.000136: (30) Responsible Party, by Official Title
p.000136: means an:
p.000136: (i) Indication of whether the respon- sible party is the sponsor of the clin- ical trial, as that term
p.000136: is defined in 21 CFR 50.3; the sponsor-investigator, as that term is defined in 21 CFR 50.3; or a
p.000136: principal investigator designated pursuant to this part; and
p.000136: (ii) Either:
p.000136: (A) The official name of the entity, if the responsible party is an entity; or
p.000136: (B) The official title and primary or- ganizational affiliation of the indi- vidual, if the responsible
p.000136: party is an in- dividual.
p.000136: (31) Facility Information means, for each participating facility in a clinical trial, the following
p.000136: information:
p.000137: 137
p.000137:
p.000137:
p.000137:
p.000137:
p.000137:
p.000137:
p.000137:
p.000137:
p.000137: § 11.10
p.000137: (i) Facility Name, meaning the full name of the organization where the clinical trial is being
p.000137: conducted;
p.000137: (ii) Facility Location, including city, state, country and zip code for U.S. lo- cations (including territories
p.000137: of the United States) and city and country for locations in other countries; and
p.000137: (iii) Either:
p.000137: (A) For each facility participating in a clinical trial, Facility Contact, in- cluding the name or
...
p.000139: (N) Studies a U.S. FDA-regulated De- vice Product;
p.000139: (O) Studies a U.S. FDA-regulated Drug Product;
p.000139: (P) Device Product Not Approved or Cleared by U.S. FDA, if any studied intervention is a device product;
p.000139: (Q) Post Prior to U.S. FDA Approval or Clearance, for an applicable device clinical trial that studies
p.000139: at least one device product not previously approved or cleared by the U.S. FDA;
p.000139: (R) Product Manufactured in and Ex- ported from the U.S., if the entry for
p.000139: U.S. Food and Drug Administration IND or IDE Number in
p.000139: § 11.28(a)(2)(iv)(C) indicates that there is no IND or IDE for the clinical trial, and the entry(ies) for
p.000139: Facility Informa- tion in § 11.28(a)(2)(iii)(C) include no fa- cility locations in the United States or its
p.000139: territories;
p.000139: (S) Study Start Date;
p.000139: (T) Primary Completion Date;
p.000139: (U) Study Completion Date;
p.000139: (V) Enrollment;
p.000139: (W) Primary Outcome Measure Infor- mation, for each primary outcome measure; and
p.000139: (X) Secondary Outcome Measure In- formation, for each secondary outcome measure.
p.000139: (ii) Recruitment information:
p.000139: (A) Eligibility Criteria;
p.000139: (B) Sex/Gender;
p.000139: (C) Age Limits;
p.000139: (D) Accepts Healthy Volunteers;
p.000139: (E) Overall Recruitment Status;
p.000139: (F) Why Study Stopped;
p.000139: (G) Individual Site Status; and
p.000139: (H) Availability of Expanded Access. If expanded access is available for an investigational drug product
p.000139: (including a biological product), an expanded ac- cess record must be submitted in ac- cordance with §
p.000139: 11.28(c), unless an ex- panded access record was submitted
p.000140: 140
p.000140:
p.000140:
p.000140:
p.000140:
p.000140:
p.000140:
p.000140:
p.000140: Public Health Service, HHS § 11.28
p.000140:
p.000140:
p.000140: previously in accordance with that pro- vision.
p.000140: (iii) Location and contact informa- tion:
p.000140: (A) Name of the Sponsor;
p.000140: (B) Responsible Party, by Official Title; and
p.000140: (C) Facility Information.
p.000140: (iv) Administrative data:
p.000140: (A) Unique Protocol Identification Number;
p.000140: (B) Secondary ID;
p.000140: (C) U.S. Food and Drug Administra- tion IND or IDE Number;
p.000140: (D) Human Subjects Protection Re- view Board Status;
p.000140: (E) Record Verification Date; and
p.000140: (F) Responsible Party Contact Infor- mation.
p.000140: (b) Pediatric postmarket surveillance of a device product that is not a clin- ical trial. For
p.000140: each pediatric postmarket surveillance of a device product that is not a clinical trial, the responsible
p.000140: party must submit the fol- lowing information:
p.000140: (1) For such applicable device clinical trials that were initiated before Janu- ary 18, 2017, the responsible
p.000140: party must submit the information specified in section 402(j)(2)(A)(ii) of the Public Health
p.000140: Service Act (42 U.S.C. 282(j)(2)(A)(ii)).
...
p.000141: part 46, or other applicable regula- tion). Human Subjects Protection Re- view Board Status must be listed as
p.000141: 42 CFR Ch. I (10–1–16 Edition)
p.000141: ‘‘approved’’ if at least one human sub- jects protection review board has ap- proved the pediatric
p.000141: postmarket sur- veillance.
p.000141: (D) Record Verification Date. The date on which the responsible party last verified the clinical
p.000141: trial information in the entire ClinicalTrials.gov record for the pediatric postmarket surveil- lance of a
p.000141: device product, even if no ad- ditional or updated information was submitted at that time
p.000141: (E) Responsible Party Contact Informa- tion. Administrative information suffi- cient to identify and allow
p.000141: communica- tion with the responsible party by tele- phone, email, and regular mail or de- livery service.
p.000141: Responsible Party Con- tact Information includes the name, of- ficial title, organizational affiliation,
p.000141: physical address, mailing address, phone number, and email address of the individual who is the responsible
p.000141: party or of a designated employee of the or- ganization that is the responsible party.
p.000141: (c) Expanded access record. If ex- panded access is available, as specified in 21 CFR 312.315
p.000141: (for an intermediate- size patient population) or 21 CFR
p.000141: 312.320 (under a treatment IND or treatment protocol), for an investiga- tional drug product
p.000141: (including a bio- logical product) studied in an applica- ble drug clinical trial, and the data ele- ments set
p.000141: forth in paragraphs (c)(1) through (4) of this section have not been submitted in an expanded
p.000141: access record for that investigational product, the responsible party, if both the man- ufacturer of the
p.000141: investigational prod- uct and the sponsor of the applicable clinical trial, must submit the clinical trial
p.000141: information specified in para- graphs (c)(1) through (4) of this section to ClinicalTrials.gov in the form
p.000141: of an expanded access record. If expanded ac- cess is available only as specified in 21 CFR 312.310 (for
p.000141: individual patients, in- cluding for emergency use) for an in- vestigational drug product (including a biological
p.000141: product) studied in an appli- cable drug clinical trial, and the data elements set forth in
p.000141: paragraphs (c)(1)(i), (iii), (iv), (vi), (ix), (x), (c)(2)(iv), (c)(3), (c)(4)(i), (iii),(iv),
p.000141: and
p.000141: (v) of this section have not been sub-
p.000141: mitted in an expanded access record for
p.000142: 142
p.000142:
p.000142:
p.000142:
p.000142:
p.000142:
p.000142:
p.000142:
p.000142: Public Health Service, HHS § 11.28
p.000142:
p.000142:
p.000142: that investigational product, the re- sponsible party, if both the manufac- turer of the
p.000142: investigational product and the sponsor of the applicable clin- ical trial, must submit the clinical
p.000142: trial information specified in those paragraphs to ClinicalTrials.gov in the form of an expanded access
p.000142: record.
p.000142: (1) Descriptive information:
p.000142: (i) Brief Title. A short title identi- fying the expanded access, written in language intended for the
p.000142: lay public. If an acronym or abbreviation is used publicly to identify the expanded ac- cess, it must be
p.000142: provided.
p.000142: (ii) Official Title. The title, if any, of the expanded access program cor- responding to the
p.000142: title that has been submitted to FDA for that program
p.000142: (iii) Brief Summary. A short descrip- tion of the availability of expanded ac- cess, including the procedure
p.000142: for re- questing the investigational drug prod- uct (including a biological product).
p.000142: (iv) Study Type. The nature of the in- vestigation or investigational use for which clinical trial
p.000142: information is being submitted, i.e., ‘‘expanded ac- cess’’.
p.000142: (v) Primary Disease or Condition. The name(s) of the disease(s) or condi- tion(s) for which
p.000142: expanded access to the investigational drug product (in- cluding a biological product) is avail- able.
p.000142: Use, if available, appropriate descriptors from NLM’s MeSH-con- trolled vocabulary thesaurus,
p.000142: or terms from another vocabulary, such as the SNOMED CT, that has been mapped to MeSH within
p.000142: the UMLS Metathesaurus.
p.000142: (vi) Intervention Name(s). A brief de- scriptive name used to refer to the in- vestigational drug product
p.000142: (including a biological product) that is available through expanded access. A non-propri- etary name of the
p.000142: intervention must be used, if available. If a non-proprietary name is not available, a brief descrip- tive
p.000142: name or identifier must be used.
p.000142: (vii) Other Intervention Name(s). Any other current and former name(s) or alias(es), different from the
p.000142: Interven- tion Name(s), that the sponsor has used publicly to identify the intervention, including, but not
p.000142: limited to, past or present names such as brand name(s), or serial numbers.
p.000142:
p.000142: (viii) Intervention Description. Details that can be made public about each intervention, other than
p.000142: the Interven- tion Name(s) or Other Intervention Name(s), sufficient to distinguish the intervention from
p.000142: other, similar inter- ventions that are available through ex- panded access or in clinical trials.
p.000142: (ix) Intervention Type. For each inves- tigational drug product (including a bi- ological product) for which
p.000142: expanded access is available, the general type of intervention, e.g., drug.
p.000142: (x) Expanded Access Type. The type(s) of expanded access for which the inves- tigational drug product (including a
p.000142: bi- ological product) is available, as speci- fied in § 11.10(b)(28).
p.000142: (2) Recruitment information:
p.000142: (i) Eligibility Criteria. A limited list of criteria for determining who is eligible to receive the
p.000142: investigational drug product (including a biological prod- uct) through expanded access, provided in terms
p.000142: of inclusion and exclusion cri- teria and suitable for assisting poten- tial patients in identifying
p.000142: investiga- tional drug products (including biologi- cal products) of interest for which ex- panded access is
p.000142: available.
p.000142: (ii) Sex/Gender. The sex and gender (if applicable) of the patients for whom expanded access is available.
p.000142: (iii) Age Limits. The minimum and maximum age of patients for whom ex- panded access is available,
p.000142: provided in relevant units of time.
p.000142: (iv) Expanded Access Status. The sta- tus of availability of the investiga- tional drug product
p.000142: (including a bio- logical product) through expanded ac- cess.
p.000142: (3) Contact information:
p.000142: (i) Name of the Sponsor.
p.000142: (ii) Responsible Party, by Official Title.
p.000142: The official name of the entity.
p.000142: (iii) Contact Information. The name or official title, toll-free telephone num- ber, and email address of a
p.000142: person to whom questions concerning expanded access can be addressed.
p.000142: (4) Administrative data:
p.000142: (i) Unique Protocol Identification Num- ber. Any unique identifier assigned by the sponsor to refer to
p.000142: the availability of its investigational drug product (in- cluding a biological product) for ex- panded
p.000142: access use or to identify the ex- panded access record.
p.000143: 143
p.000143:
p.000143:
p.000143:
p.000143:
p.000143:
p.000143:
p.000143:
p.000143:
p.000143: § 11.35
p.000143: (ii) Secondary ID: (A) Any identi- fier(s) other than the Unique Protocol Identification Number or
p.000143: the NCT number that is assigned to the ex- panded access record, including any unique
p.000143: identifiers assigned by other publicly available clinical trial or ex- panded access registries.
p.000143: (B) For each Secondary ID listed, a description of the type of Secondary ID.
p.000143: (iii) U.S. Food and Drug Administra- tion IND Number. An indication of whether there is an IND
p.000143: and, if so, each of the following elements:
p.000143: (A) Name or abbreviation of the FDA center with whom the IND is filed (i.e., CDER or CBER), if applicable;
p.000143: (B) IND number (assigned by the FDA center) under which the investiga- tional drug product (including a
p.000143: bio- logical product) is being made avail- able for expanded access, if applicable; and
p.000143: (C) IND serial number. as defined in 21 CFR 312.23(e), if any, assigned to the expanded access.
p.000143: (iv) Record Verification Date. The date on which the responsible party last verified the information
p.000143: in the ex- panded access record, even if no addi- tional or updated information was sub- mitted at that time.
p.000143: (v) Responsible Party Contact Informa- tion. Administrative information suffi- cient to identify and allow
p.000143: communica- tion with the responsible party enter- ing the clinical trial information into the expanded
p.000143: access record by tele- phone, email, and regular mail or de- livery service. Responsible Party Con-
p.000143: tact Information includes the name, of- ficial title, organizational affiliation, physical address,
p.000143: mailing address, phone number, and email address of the individual who is the responsible party or of a
p.000143: designated employee of the or- ganization that is the responsible party.
p.000143: § 11.35 By when will the NIH Director post clinical trial registration infor- mation submitted under § 11.28?
p.000143: (a) Applicable drug clinical trial. The Director will post publicly on ClinicalTrials.gov the
p.000143: clinical trial reg- istration information, except for cer- tain administrative data, for an appli- cable
p.000143: drug clinical trial not later than
p.000143: 42 CFR Ch. I (10–1–16 Edition)
p.000143: 30 calendar days after the responsible party has submitted such information, as specified in § 11.24.
p.000143: (b) Applicable device clinical trial. (1) For an applicable device clinical trial of a device product that
p.000143: was previously approved or cleared, the Director will post publicly on ClinicalTrials.gov the clinical trial
p.000143: registration information, except for certain administrative data, as soon as practicable, but not later
p.000143: than 30 calendar days after clinical trial results information is required to be posted, as specified in
p.000143: § 11.52.
...
p.000154: U.S.C. 282(j)(2)(A)(ii)) has not been sub- mitted, the responsible party must sub- mit the data elements
p.000154: specified in
p.000154: § 11.48, as well as the data elements listed below, as those data elements are defined in §
p.000154: 11.10(b) and apply to the clinical trial and the intervention(s) studied: Brief Title; Official Title; Brief
p.000154:
p.000154: Summary; Primary Purpose; Study De- sign; Study Phase, for a clinical trial of a drug product (including a
p.000154: biological product); Study Type; Pediatric Postmarket Surveillance of a Device Product; Primary
p.000154: Disease or Condition Being Studied in the Trial, or the Focus of the Study; Intervention
p.000154: Name(s), for each intervention studied; Other Intervention Name(s), for each intervention studied; Intervention
p.000154: De- scription, for each intervention stud- ied; Intervention Type, for each inter- vention studied; Device
p.000154: Product Not Approved or Cleared by U.S. FDA, if any studied intervention is a device product;
p.000154: Product Manufactured in and Exported from the U.S.; Studies a U.S. FDA-regulated Device Product; Studies a
p.000154: U.S. FDA-regulated Drug Product; Study Start Date; Primary Completion Date; Study Completion Date; Enroll-
p.000154: ment; Eligibility Criteria; Sex/Gender; Age Limits; Accepts Healthy Volun- teers; Overall Recruitment
p.000154: Status; Why Study Stopped; Availability of Ex- panded Access, if any studied interven- tion is an investigational
p.000154: drug product (including a biological product); Name of the Sponsor; Responsible Party, by Official Title;
p.000154: Facility Information, for each participating facility; Unique Protocol Identification Number; Sec-
p.000154: ondary ID; U.S. Food and Drug Admin- istration IND or IDE Number; Human Subjects Protection Review Board Sta- tus;
p.000154: Record Verification Date; and Re- sponsible Party Contact Information.
p.000154: (C) If the responsible party both vol-
p.000154: untarily submits clinical trial registra- tion information and voluntarily sub- mits clinical trial results
p.000154: information, the responsible party must submit both the clinical trial registration informa- tion specified in
p.000154: section 402(j)(2)(A)(ii) of the Public Health Service Act (42
p.000154: U.S.C. 282(j)(2)(A)(ii)) and the clinical trial results information specified in
p.000154: § 11.48.
p.000154: (ii) If, on or after September 27, 2007, a manufacturer submits an application or premarket notification to
p.000154: FDA for approval, licensure, or clearance of a drug product (including a biological product) or device
p.000154: product under sec- tion 505, 510(k), 515, or 520(m) of the Federal Food, Drug, and Cosmetic Act (21
...
p.000158: Public Health Service Act (42 U.S.C. 282(j)(2)(A)(ii)) that was required at the time of
p.000158: submission must be updated not less than once every 12 months.
p.000158: (B) Overall Recruitment Status must be updated not later than 30 calendar days after any change in
p.000158: overall re- cruitment status.
p.000158: (C) Primary Completion Date must be updated not later than 30 calendar days after the clinical trial
p.000158: reaches its actual primary completion date.
p.000158: (ii) The responsible party for an ap- plicable clinical trial, or for another
p.000159: 159
p.000159:
p.000159:
p.000159:
p.000159:
p.000159:
p.000159:
p.000159:
p.000159:
p.000159: § 11.64
p.000159: clinical trial for which registration in- formation was voluntarily submitted pursuant to § 11.60(c),
p.000159: if the clinical trial was initiated on or after January 18, 2017, must submit updates in ac-
p.000159: cordance with the following:
p.000159: (A) In general, changes to clinical trial registration information specified in § 11.28 must be updated not
p.000159: less than once every 12 months.
p.000159: (B) If the first human subject was not enrolled in the clinical trial at the time of registration, the
p.000159: Study Start Date data element must be updated not later than 30 calendar days after the first human subject is
p.000159: enrolled.
p.000159: (C) Intervention Name(s) must be up- dated to a non-proprietary name not later than 30 calendar days after a non-
p.000159: proprietary name is established for any intervention included in the Interven- tion Name(s) data element.
p.000159: (D) Availability of expanded access:
p.000159: (1) If expanded access to an investiga- tional drug product (including a bio- logical product) becomes
p.000159: available after an applicable clinical trial of that product has been registered, the re- sponsible party,
p.000159: if both the manufac- turer of the investigational drug prod- uct (including a biological product) and the
p.000159: sponsor of the applicable clinical trial, must, not later than 30 calendar days after expanded access
p.000159: becomes available, update the Availability of Expanded Access data element for that applicable clinical trial
p.000159: and, unless an expanded access record has already been created as required by
p.000159: § 11.28(a)(2)(ii)(H), submit the data ele-
p.000159: ments in accordance with § 11.28(c) to create an expanded access record.
p.000159: (2) No later than 30 calendar days after the date on which the responsible party receives an NCT number
p.000159: for an expanded access record created as re- quired by § 11.28(a)(2)(ii)(H), the respon- sible party must
p.000159: update the Avail- ability of Expanded Access data ele- ment by entering the NCT number in the
p.000159: clinical trial record for the applica- ble clinical trial.
p.000159: (E) Expanded access record:
p.000159: (1) Expanded Access Status, under
p.000159: § 11.28(c)(2)(iv), must be updated not later than 30 calendar days after a change in the
p.000159: availability of expanded access to an investigational drug prod- uct (including a biological product)
p.000159: 42 CFR Ch. I (10–1–16 Edition)
p.000159: under section 561 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360bbb).
p.000159: (2) Expanded Access Type, under
p.000159: § 11.28(c)(1)(x), must be updated not later than 30 calendar days after a change in the type(s)
p.000159: of expanded ac- cess available for an investigational drug product (including a biological product)
p.000159: under section 561 of the Fed- eral Food, Drug, and Cosmetic Act (21
p.000159: U.S.C. 360bbb).
p.000159: (F) Overall Recruitment Status must be updated not later than 30 calendar days after any change in
p.000159: overall re- cruitment status. If, at any time, Over- all Recruitment Status is changed to ‘‘suspended,’’
p.000159: ‘‘terminated,’’ or ‘‘with- drawn,’’ the responsible party must also submit the Why Study Stopped
p.000159: data element.
p.000159: (G) Individual Site Status must be updated not later than 30 calendar days after a change in status for any
p.000159: indi- vidual site.
p.000159: (H) Human Subjects Protection Re- view Board Status must be updated not later than 30 calendar days after
p.000159: a change in status.
p.000159: (I) Primary Completion Date must be updated not later than 30 calendar days after the clinical trial reaches its
p.000159: ac- tual primary completion date. At the time, the date is changed to ‘‘actual,’’ and the Enrollment
p.000159: data element specifying the actual number of par- ticipants enrolled must be submitted.
p.000159: (J) Study Completion Date must be updated not later than 30 calendar days after the clinical trial reaches
p.000159: its ac- tual study completion date.
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p.000133: NCT number means the unique identi- fication code assigned to each record in ClinicalTrials.gov, including a record
p.000133: for an applicable clinical trial, a clinical trial, or an expanded access program.
p.000133: Ongoing means, with respect to a clinical trial of a drug product (includ- ing a biological product) or
p.000133: a device product and to a date, that one or more human subjects is enrolled in the clin- ical trial, and the
p.000133: date is before the primary completion date of the clinical trial. With respect to a pediatric
p.000133: postmarket surveillance of a device product, ongoing means a date between the date on which FDA approves
p.000133: the plan for conducting the surveillance and the date on which the final report is submitted to FDA.
p.000133: Outcome measure means a pre-speci-
p.000133: fied measurement that will be used to
p.000133: 42 CFR Ch. I (10–1–16 Edition)
p.000133: determine the effect of an experi- mental variable on the human sub- ject(s) in a clinical
p.000133: trial. See also the definitions of ‘‘primary outcome meas- ure’’ and ‘‘secondary outcome meas- ure.’’
p.000133: Pediatric postmarket surveillance of a device product means the active, sys- tematic, scientifically
p.000133: valid collection, analysis, and interpretation of data or other information conducted under sec- tion 522 of the
p.000133: Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360l) about a marketed device product that is ex-
p.000133: pected to have significant use in pa- tients who are 21 years of age or young- er at the time of diagnosis
p.000133: or treat- ment. A pediatric postmarket surveil- lance of a device product may be, but is not always, a clinical
p.000133: trial.
p.000133: Primary completion date means, for
p.000133: purposes of this part, ‘‘completion date.’’ See the definition of ‘‘comple- tion date.’’
p.000133: Primary outcome measure means the outcome measure(s) of greatest impor- tance specified in the protocol,
p.000133: usually the one(s) used in the power calcula- tion. Most clinical trials have one pri- mary outcome
p.000133: measure, but a clinical trial may have more than one. For pur- poses of this part, ‘‘primary outcome’’ has the
p.000133: same meaning as primary out- come measure.
p.000133: Principal investigator means the indi- vidual who is responsible for the over- all scientific and technical
p.000133: direction of the study.
p.000133: Protocol means the written descrip- tion of the clinical trial, including ob- jective(s), design, and
p.000133: methods. It may also include relevant scientific back- ground and statistical considerations.
p.000133: Responsible party means, with respect to a clinical trial, the sponsor of the clinical trial, as defined in
p.000133: 21 CFR 50.3; or the principal investigator of such clinical trial if so designated by a spon- sor, grantee,
p.000133: contractor, or awardee, so long as the principal investigator is re- sponsible for conducting the trial, has
p.000133: access to and control over the data from the clinical trial, has the right to publish the results of the
p.000133: trial, and has the ability to meet all of the require- ments under this part for the submis- sion of
...
p.000136: 136
p.000136:
p.000136:
p.000136:
p.000136:
p.000136:
p.000136:
p.000136:
p.000136: Public Health Service, HHS § 11.10
p.000136:
p.000136:
p.000136: (19) Primary Outcome Measure Informa- tion means a description of each pri- mary outcome measure, to include
p.000136: the following information:
p.000136: (i) Name of the specific primary out- come measure;
p.000136: (ii) Description of the metric used to characterize the specific primary out- come measure; and
p.000136: (iii) Time point(s) at which the meas- urement is assessed for the specific metric used.
p.000136: (20) Secondary Outcome Measure Infor- mation means a description of each sec- ondary outcome measure, to
p.000136: include the following information:
p.000136: (i) Name of the specific secondary outcome measure;
p.000136: (ii) Description of the metric used to characterize the specific secondary outcome measure; and
p.000136: (iii) Time point(s) at which the meas- urement is assessed for the specific metric used.
p.000136: (21) Eligibility Criteria means a limited list of criteria for selection of human subjects to participate in
p.000136: the clinical trial, provided in terms of inclusion and exclusion criteria and suitable for assisting
p.000136: potential human subjects in identifying clinical trials of interest.
p.000136: (22) Sex/Gender means the sex and, if applicable, gender of the human sub- jects who may participate in
p.000136: the clin- ical trial.
p.000136: (23) Age Limits means the minimum and maximum age of human subjects who may participate in the
p.000136: clinical trial, provided in relevant units of time.
p.000136: (24) Accepts Healthy Volunteers means that human subjects who do not have a disease or condition, or related
p.000136: condi- tions or symptoms, under study in the clinical trial are permitted to partici- pate in the clinical
p.000136: trial.
p.000136: (25) Overall Recruitment Status means the recruitment status for the clinical trial as a whole, based on the
p.000136: status of the individual sites. If at least one fa- cility in a multi-site clinical trial has an
p.000136: individual site status of ‘‘recruit- ing,’’ then the overall recruitment sta- tus for the trial must be
p.000136: ‘‘recruiting.’’
p.000136: (26) Why Study Stopped means, for a clinical trial that is suspended or ter- minated or withdrawn
p.000136: prior to its planned completion as anticipated by the protocol, a brief explanation of the
p.000136:
p.000136: reason(s) why the clinical trial was stopped.
p.000136: (27) Individual Site Status means the recruitment status of each partici- pating facility in a
p.000136: clinical trial.
p.000136: (28) Availability of Expanded Access means, for an applicable drug clinical trial of a drug product
p.000136: (including a bio- logical product) that is not an ap- proved drug product (including a bio- logical
...
p.000139: (J) Intervention Name(s), for each intervention studied;
p.000139: (K) Other Intervention Name(s), for each intervention studied;
p.000139: (L) Intervention Description, for each intervention studied;
p.000139: (M) Intervention Type, for each intervention studied;
p.000139: (N) Studies a U.S. FDA-regulated De- vice Product;
p.000139: (O) Studies a U.S. FDA-regulated Drug Product;
p.000139: (P) Device Product Not Approved or Cleared by U.S. FDA, if any studied intervention is a device product;
p.000139: (Q) Post Prior to U.S. FDA Approval or Clearance, for an applicable device clinical trial that studies
p.000139: at least one device product not previously approved or cleared by the U.S. FDA;
p.000139: (R) Product Manufactured in and Ex- ported from the U.S., if the entry for
p.000139: U.S. Food and Drug Administration IND or IDE Number in
p.000139: § 11.28(a)(2)(iv)(C) indicates that there is no IND or IDE for the clinical trial, and the entry(ies) for
p.000139: Facility Informa- tion in § 11.28(a)(2)(iii)(C) include no fa- cility locations in the United States or its
p.000139: territories;
p.000139: (S) Study Start Date;
p.000139: (T) Primary Completion Date;
p.000139: (U) Study Completion Date;
p.000139: (V) Enrollment;
p.000139: (W) Primary Outcome Measure Infor- mation, for each primary outcome measure; and
p.000139: (X) Secondary Outcome Measure In- formation, for each secondary outcome measure.
p.000139: (ii) Recruitment information:
p.000139: (A) Eligibility Criteria;
p.000139: (B) Sex/Gender;
p.000139: (C) Age Limits;
p.000139: (D) Accepts Healthy Volunteers;
p.000139: (E) Overall Recruitment Status;
p.000139: (F) Why Study Stopped;
p.000139: (G) Individual Site Status; and
p.000139: (H) Availability of Expanded Access. If expanded access is available for an investigational drug product
p.000139: (including a biological product), an expanded ac- cess record must be submitted in ac- cordance with §
p.000139: 11.28(c), unless an ex- panded access record was submitted
p.000140: 140
p.000140:
p.000140:
p.000140:
p.000140:
p.000140:
p.000140:
p.000140:
p.000140: Public Health Service, HHS § 11.28
p.000140:
p.000140:
p.000140: previously in accordance with that pro- vision.
p.000140: (iii) Location and contact informa- tion:
p.000140: (A) Name of the Sponsor;
p.000140: (B) Responsible Party, by Official Title; and
p.000140: (C) Facility Information.
p.000140: (iv) Administrative data:
p.000140: (A) Unique Protocol Identification Number;
p.000140: (B) Secondary ID;
p.000140: (C) U.S. Food and Drug Administra- tion IND or IDE Number;
p.000140: (D) Human Subjects Protection Re- view Board Status;
p.000140: (E) Record Verification Date; and
p.000140: (F) Responsible Party Contact Infor- mation.
...
p.000142: (ix) Intervention Type. For each inves- tigational drug product (including a bi- ological product) for which
p.000142: expanded access is available, the general type of intervention, e.g., drug.
p.000142: (x) Expanded Access Type. The type(s) of expanded access for which the inves- tigational drug product (including a
p.000142: bi- ological product) is available, as speci- fied in § 11.10(b)(28).
p.000142: (2) Recruitment information:
p.000142: (i) Eligibility Criteria. A limited list of criteria for determining who is eligible to receive the
p.000142: investigational drug product (including a biological prod- uct) through expanded access, provided in terms
p.000142: of inclusion and exclusion cri- teria and suitable for assisting poten- tial patients in identifying
p.000142: investiga- tional drug products (including biologi- cal products) of interest for which ex- panded access is
p.000142: available.
p.000142: (ii) Sex/Gender. The sex and gender (if applicable) of the patients for whom expanded access is available.
p.000142: (iii) Age Limits. The minimum and maximum age of patients for whom ex- panded access is available,
p.000142: provided in relevant units of time.
p.000142: (iv) Expanded Access Status. The sta- tus of availability of the investiga- tional drug product
p.000142: (including a bio- logical product) through expanded ac- cess.
p.000142: (3) Contact information:
p.000142: (i) Name of the Sponsor.
p.000142: (ii) Responsible Party, by Official Title.
p.000142: The official name of the entity.
p.000142: (iii) Contact Information. The name or official title, toll-free telephone num- ber, and email address of a
p.000142: person to whom questions concerning expanded access can be addressed.
p.000142: (4) Administrative data:
p.000142: (i) Unique Protocol Identification Num- ber. Any unique identifier assigned by the sponsor to refer to
p.000142: the availability of its investigational drug product (in- cluding a biological product) for ex- panded
p.000142: access use or to identify the ex- panded access record.
p.000143: 143
p.000143:
p.000143:
p.000143:
p.000143:
p.000143:
p.000143:
p.000143:
p.000143:
p.000143: § 11.35
p.000143: (ii) Secondary ID: (A) Any identi- fier(s) other than the Unique Protocol Identification Number or
p.000143: the NCT number that is assigned to the ex- panded access record, including any unique
...
p.000147: (2) Demographic and baseline charac- teristics. Information for completing a table of demographic
p.000147: and baseline measures and data collected by arm or comparison group and for the entire population
p.000147: of human subjects who par- ticipated in the clinical trial. This in- formation must include the following
p.000147: elements:
p.000147: (i) Baseline Characteristics Arm/Group Information. A brief description of each arm or comparison group
p.000147: used for de- scribing the demographic and baseline characteristics of the human subjects in the clinical
p.000147: trial, including a de- scriptive title used to identify each arm or comparison group.
p.000147: (ii) Baseline Analysis Population Infor- mation—(A) Overall Number of Baseline Participants. The total
p.000147: number of human subjects for whom baseline characteristics were measured, by arm or comparison group
p.000147: and overall.
p.000147: (B) Overall Number of Units Analyzed. If the analysis is based on a unit other than participants, a description
p.000147: of the unit of analysis and the number of units for which baseline measures were measured and analyzed,
p.000147: by arm or com- parison group and overall.
p.000147: (C) Analysis Population Description. If the Overall Number of Baseline Par- ticipants (or units) differs
p.000147: from the number of human subjects (or units) assigned to the arm or comparison group and overall, a
p.000147: brief description of the reason(s) for the difference.
p.000147: (iii) Baseline Measure Information. A description of each baseline or demo- graphic characteristic
p.000147: measured in the clinical trial, including age, sex/gender, race, ethnicity (if collected under the
p.000148: 148
p.000148:
p.000148:
p.000148:
p.000148:
p.000148:
p.000148:
p.000148:
p.000148: Public Health Service, HHS § 11.48
p.000148:
p.000148:
p.000148: protocol), and any other measure(s) that were assessed at baseline and are used in the analysis
p.000148: of the primary outcome measure(s) in accordance with
p.000148: § 11.48(a)(3). The description of each measure must include the following elements:
p.000148: (A) Name and description of the measure, including any categories that are used to submit Baseline
p.000148: Measure Data.
p.000148: (B) Measure Type and Measure of Dis- persion: For each baseline measure sub- mitted, an indication of
p.000148: the type of data to be submitted and the associ- ated measure of dispersion.
p.000148: (C) Unit of Measure. For each baseline measure for which data are collected, the unit of measure.
p.000148: (iv) Baseline Measure Data. The value(s) for each submitted baseline measure, by arm or
p.000148: comparison group and for the entire population of human subjects for whom baseline characteris- tics were measured.
p.000148: (v) Number of baseline participants (and units), by arm or comparison group and overall, if different
p.000148: from the Overall Number of Baseline Partici- pants or Overall Number of Units Ana- lyzed in §
p.000148: 11.48(a)(2)(ii)(A) and (B), re- spectively.
p.000148: (3) Outcomes and statistical analyses. Information for completing a table of data for each primary and
...
p.000150: the principal investigator, after the pri- mary completion date of the clinical trial, to discuss the
p.000150: results of the clin- ical trial at a scientific meeting or any
p.000150:
p.000150: other public or private forum or to publish in a scientific or academic journal information
p.000150: concerning the re- sults of the clinical trial
p.000150: (7) Additional clinical trial results infor- mation for applicable device clinical trials of unapproved or
p.000150: uncleared device prod- ucts. (i) For an applicable device clin- ical trial of an unapproved or uncleared device
p.000150: product and for which clinical trial registration information has not been posted publicly on
p.000150: Clinical Trials.gov by the Director in accord- ance with § 11.35(b)(2)(i), the responsible party must provide
p.000150: the following data elements, as the data elements are de- fined in § 11.10(b): Brief Title; Official
p.000150: Title; Brief Summary; Primary Pur- pose; Study Design; Study Type; Pri- mary Disease or Condition Being
p.000150: Stud- ied in the Trial, or the Focus of the Study; Intervention Name(s); Other Intervention Name(s);
p.000150: Intervention De- scription; Intervention Type; Device Product Not Approved or Cleared by
p.000150: U.S. FDA, if any studied intervention is a device product; Study Start Date; Primary Completion Date; Study
p.000150: Com- pletion Date, Enrollment; Primary Outcome Measure Information; Sec- ondary Outcome Measure
p.000150: Information; Eligibility Criteria; Sex/Gender; Age Limits; Accepts Healthy Volunteers; Overall
p.000150: Recruitment Status; Why Study Stopped; Name of the Sponsor; Responsible Party, by Official Title;
p.000150: Facility Name and Facility Location, for each participating facility in a clin- ical trial; Unique Protocol
p.000150: Identifica- tion Number; Secondary ID; Human Subjects Protection Review Board Sta- tus; and Record Verification
p.000150: Date.
p.000150: (ii) The responsible party shall sub-
p.000150: mit all the results information speci- fied in paragraph (a)(7)(i) and must sub- mit an affirmation that any
p.000150: informa- tion previously submitted to ClinicalTrials.gov for the data elements listed in
p.000150: paragraph (a)(7)(i) of this sec- tion have been updated in accordance with § 11.64(a) and are to be included
p.000150: as clinical trial results information.
p.000150: (b) Pediatric postmarket surveillance of
p.000150: a device product that is not a clinical trial. For each pediatric postmarket surveillance of a
p.000150: device product that is not a clinical trial, the responsible party must submit a copy of any final
p.000150: report that is submitted to FDA as
p.000151: 151
p.000151:
p.000151:
p.000151:
p.000151:
p.000151:
p.000151:
p.000151:
p.000151:
p.000151: § 11.52
p.000151: specified in 21 CFR 822.38. The respon- sible party may redact names, address- es, and other personally
...
p.000154: clinical trial for which the clinical trial registration informa- tion specified in section 402(j)(2)(A)(ii)
p.000154: of the Public Health Service Act (42
p.000154: U.S.C. 282(j)(2)(A)(ii)) has not been sub- mitted, the responsible party must sub- mit the data elements
p.000154: specified in
p.000154: § 11.48, as well as the data elements listed below, as those data elements are defined in §
p.000154: 11.10(b) and apply to the clinical trial and the intervention(s) studied: Brief Title; Official Title; Brief
p.000154:
p.000154: Summary; Primary Purpose; Study De- sign; Study Phase, for a clinical trial of a drug product (including a
p.000154: biological product); Study Type; Pediatric Postmarket Surveillance of a Device Product; Primary
p.000154: Disease or Condition Being Studied in the Trial, or the Focus of the Study; Intervention
p.000154: Name(s), for each intervention studied; Other Intervention Name(s), for each intervention studied; Intervention
p.000154: De- scription, for each intervention stud- ied; Intervention Type, for each inter- vention studied; Device
p.000154: Product Not Approved or Cleared by U.S. FDA, if any studied intervention is a device product;
p.000154: Product Manufactured in and Exported from the U.S.; Studies a U.S. FDA-regulated Device Product; Studies a
p.000154: U.S. FDA-regulated Drug Product; Study Start Date; Primary Completion Date; Study Completion Date; Enroll-
p.000154: ment; Eligibility Criteria; Sex/Gender; Age Limits; Accepts Healthy Volun- teers; Overall Recruitment
p.000154: Status; Why Study Stopped; Availability of Ex- panded Access, if any studied interven- tion is an investigational
p.000154: drug product (including a biological product); Name of the Sponsor; Responsible Party, by Official Title;
p.000154: Facility Information, for each participating facility; Unique Protocol Identification Number; Sec-
p.000154: ondary ID; U.S. Food and Drug Admin- istration IND or IDE Number; Human Subjects Protection Review Board Sta- tus;
p.000154: Record Verification Date; and Re- sponsible Party Contact Information.
p.000154: (C) If the responsible party both vol-
p.000154: untarily submits clinical trial registra- tion information and voluntarily sub- mits clinical trial results
p.000154: information, the responsible party must submit both the clinical trial registration informa- tion specified in
p.000154: section 402(j)(2)(A)(ii) of the Public Health Service Act (42
p.000154: U.S.C. 282(j)(2)(A)(ii)) and the clinical trial results information specified in
p.000154: § 11.48.
p.000154: (ii) If, on or after September 27, 2007, a manufacturer submits an application or premarket notification to
p.000154: FDA for approval, licensure, or clearance of a drug product (including a biological product) or device
...
Social / Ethnicity
Searching for indicator ethnicity:
(return to top)
p.000147: of human subjects who par- ticipated in the clinical trial. This in- formation must include the following
p.000147: elements:
p.000147: (i) Baseline Characteristics Arm/Group Information. A brief description of each arm or comparison group
p.000147: used for de- scribing the demographic and baseline characteristics of the human subjects in the clinical
p.000147: trial, including a de- scriptive title used to identify each arm or comparison group.
p.000147: (ii) Baseline Analysis Population Infor- mation—(A) Overall Number of Baseline Participants. The total
p.000147: number of human subjects for whom baseline characteristics were measured, by arm or comparison group
p.000147: and overall.
p.000147: (B) Overall Number of Units Analyzed. If the analysis is based on a unit other than participants, a description
p.000147: of the unit of analysis and the number of units for which baseline measures were measured and analyzed,
p.000147: by arm or com- parison group and overall.
p.000147: (C) Analysis Population Description. If the Overall Number of Baseline Par- ticipants (or units) differs
p.000147: from the number of human subjects (or units) assigned to the arm or comparison group and overall, a
p.000147: brief description of the reason(s) for the difference.
p.000147: (iii) Baseline Measure Information. A description of each baseline or demo- graphic characteristic
p.000147: measured in the clinical trial, including age, sex/gender, race, ethnicity (if collected under the
p.000148: 148
p.000148:
p.000148:
p.000148:
p.000148:
p.000148:
p.000148:
p.000148:
p.000148: Public Health Service, HHS § 11.48
p.000148:
p.000148:
p.000148: protocol), and any other measure(s) that were assessed at baseline and are used in the analysis
p.000148: of the primary outcome measure(s) in accordance with
p.000148: § 11.48(a)(3). The description of each measure must include the following elements:
p.000148: (A) Name and description of the measure, including any categories that are used to submit Baseline
p.000148: Measure Data.
p.000148: (B) Measure Type and Measure of Dis- persion: For each baseline measure sub- mitted, an indication of
p.000148: the type of data to be submitted and the associ- ated measure of dispersion.
p.000148: (C) Unit of Measure. For each baseline measure for which data are collected, the unit of measure.
p.000148: (iv) Baseline Measure Data. The value(s) for each submitted baseline measure, by arm or
p.000148: comparison group and for the entire population of human subjects for whom baseline characteris- tics were measured.
p.000148: (v) Number of baseline participants (and units), by arm or comparison group and overall, if different
p.000148: from the Overall Number of Baseline Partici- pants or Overall Number of Units Ana- lyzed in §
p.000148: 11.48(a)(2)(ii)(A) and (B), re- spectively.
p.000148: (3) Outcomes and statistical analyses. Information for completing a table of data for each primary and
p.000148: secondary outcome measure by arm or compari- son group, including the result(s) of scientifically
...
Social / Linguistic Proficiency
Searching for indicator language:
(return to top)
p.000134: the development of a substance use disorder.
p.000134: Sponsor means either a ‘‘sponsor’’ or
p.000134: ‘‘sponsor-investigator,’’ as each is de- fined in 21 CFR 50.3.
p.000134: Study completion date means, for a clinical trial, the date the final subject was examined or received an
p.000134: interven- tion for purposes of final collection of data for the primary and secondary outcome
p.000134: measures and adverse events
p.000134:
p.000134: (e.g., last subject’s last visit), whether the clinical trial concluded according to the pre-specified
p.000134: protocol or was ter- minated.
p.000134: U.S. FDA-regulated device product means, for purposes of this part, a de- vice product subject to
p.000134: section 510(k), 515, 520(m), or 522 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360(k),
p.000134: 21 U.S.C. 360e, 21 U.S.C. 360j(m), 21 U.S.C. 360l).
p.000134: U.S. FDA-regulated drug product means, for purposes of this part, a drug product subject to section
p.000134: 505 of the Federal Food, Drug, and Cosmetic Act or a biological product subject to sec- tion 351 of the
p.000134: Public Health Service Act (21 U.S.C. 355, 42 U.S.C. 262) .
p.000134: (b) The following definitions apply to data elements of clinical trial informa- tion referenced in this part, unless
p.000134: oth- erwise specified:
p.000134: (1) Brief Title means a short title of the clinical trial written in language intended for the lay
p.000134: public, including any acronym or abbreviation used pub- licly to identify the clinical trial.
p.000134: (2) Official Title means the title of the clinical trial, corresponding to the title of the protocol.
p.000134: (3) Brief Summary means a short de- scription of the clinical trial, including a brief statement of the
p.000134: clinical trial’s hypothesis, written in language in- tended for the lay public.
p.000134: (4) Primary Purpose means the main objective of the intervention(s) being evaluated by the clinical trial.
p.000134: (5) Study Design means a description of the manner in which the clinical trial will be conducted,
p.000134: including the following information:
p.000134: (i) Interventional Study Model. The strategy for assigning interventions to human subjects.
p.000134: (ii) Number of Arms. The number of arms in the clinical trial. For a trial with multiple periods or
p.000134: phases that have different numbers of arms, it means the maximum number of arms during all periods or
p.000134: phases.
p.000134: (iii) Arm Information. A description of each arm of the clinical trial that indi- cates its role in the clinical
p.000134: trial, pro- vides an informative title, and, if nec- essary, additional descriptive informa- tion (including
p.000134: which interventions are
p.000135: 135
p.000135:
p.000135:
p.000135:
p.000135:
p.000135:
p.000135:
p.000135:
p.000135:
p.000135: § 11.10
p.000135: administered in each arm) to differen- tiate each arm from other arms in the clinical trial.
p.000135: (iv) Allocation. The method by which human subjects are assigned to arms in a clinical trial.
p.000135: (v) Masking. The party or parties, if any, involved in the clinical trial who are prevented from having
p.000135: knowledge of the interventions assigned to indi- vidual human subjects.
p.000135: (6) Study Phase means, for a clinical trial of a drug product (including a bio- logical product), the
p.000135: numerical phase of such clinical trial, consistent with terminology in 21 CFR 312.21, such as phase 2 or
p.000135: phase 3, and in 21 CFR 312.85 for phase 4 studies.
p.000135: (7) Study Type means the nature of the investigation or investigational use for which clinical trial
p.000135: information is being submitted, e.g., interventional, observational.
p.000135: (8) Pediatric Postmarket Surveillance of a Device Product means a clinical trial or study that includes a
p.000135: U.S. FDA-reg- ulated device product as an interven- tion and is a pediatric postmarket sur- veillance of a
p.000135: device product ordered under section 522 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 369l).
p.000135: (9) Primary Disease or Condition Being
p.000135: Studied in the Trial, or the Focus of the Study means the name(s) of the dis- ease(s) or
p.000135: condition(s) studied in the clinical trial, or the focus of the clin- ical trial. Use, if available,
p.000135: appropriate descriptors from NLM’s Medical Sub- ject Headings (MeSH)-controlled vocab- ulary thesaurus or terms
p.000135: from another vocabulary, such as the Systematized Nomenclature of Medicine—Clinical Terms (SNOMED CT),
p.000135: that has been mapped to MeSH within the Unified Medical Language System (UMLS) Metathesaurus.
p.000135: (10) Intervention Name(s) means a brief
p.000135: descriptive name used to refer to the intervention(s) studied in each arm of the clinical trial. A
p.000135: non-proprietary name of the intervention must be used, if available. If a non-proprietary name is not
p.000135: available, a brief descriptive name or identifier must be used.
p.000135: (11) Other Intervention Name(s) means other current and former name(s) or alias(es), if any, different
p.000135: from the Intervention Name(s), that the sponsor has used publicly to identify the inter-
p.000135: 42 CFR Ch. I (10–1–16 Edition)
p.000135: vention(s), including, but not limited to, past or present names such as brand name(s), or serial numbers.
p.000135: (12) Intervention Description means de- tails that can be made public about the intervention, other than the
p.000135: Interven- tion Name(s) and Other Intervention Name(s), sufficient to distinguish the intervention from
p.000135: other, similar inter- ventions studied in the same or an- other clinical trial. For example, inter-
p.000135: ventions involving drugs may include dosage form, dosage, frequency, and du- ration.
p.000135: (13) Intervention Type means, for each intervention studied in the clinical trial, the general type of
p.000135: intervention, e.g., drug, biological/vaccine, or, de- vice.
p.000135: (14) Device Product Not Approved or Cleared by U.S. FDA means that at least one device product
p.000135: studied in the clinical trial has not been previously approved or cleared by FDA for one or more uses.
...
p.000140: (A) Name of the Sponsor;
p.000140: (B) Responsible Party, by Official Title; and
p.000140: (C) Facility Information.
p.000140: (iv) Administrative data:
p.000140: (A) Unique Protocol Identification Number;
p.000140: (B) Secondary ID;
p.000140: (C) U.S. Food and Drug Administra- tion IND or IDE Number;
p.000140: (D) Human Subjects Protection Re- view Board Status;
p.000140: (E) Record Verification Date; and
p.000140: (F) Responsible Party Contact Infor- mation.
p.000140: (b) Pediatric postmarket surveillance of a device product that is not a clin- ical trial. For
p.000140: each pediatric postmarket surveillance of a device product that is not a clinical trial, the responsible
p.000140: party must submit the fol- lowing information:
p.000140: (1) For such applicable device clinical trials that were initiated before Janu- ary 18, 2017, the responsible
p.000140: party must submit the information specified in section 402(j)(2)(A)(ii) of the Public Health
p.000140: Service Act (42 U.S.C. 282(j)(2)(A)(ii)).
p.000140: (2) For such applicable device clinical trials that are initiated on or after January 18, 2017, the
p.000140: responsible party must submit the data elements listed below:
p.000140: (i) Descriptive information:
p.000140: (A) Brief Title. A short title of the pe- diatric postmarket surveillance of a device product in language
p.000140: intended for the lay public. If an acronym or abbre- viation is used to publicly identify the surveillance, it
p.000140: must be provided.
p.000140: (B) Official Title. The title of the pedi- atric postmarket surveillance of a de- vice product, corresponding to
p.000140: the title of the protocol or the FDA-approved plan for conducting the surveillance
p.000140: (C) Brief Summary. A short descrip- tion of the pediatric postmarket sur- veillance of a device product,
p.000140: including a brief statement of the hypothesis or objective, written in language intended for the lay public,
p.000140: and a general de- scription of the surveillance design, in- cluding relevant population informa- tion
p.000140:
p.000140: (D) Study Type. The type of study being registered. In the case of a pedi- atric postmarket
p.000140: surveillance of a de- vice product that is not a clinical trial, a study type of ‘‘observational’’ is re-
p.000140: quired.
p.000140: (E) Pediatric Postmarket Surveillance of a Device Product. For a study that in- cludes an FDA-regulated
p.000140: device prod- uct as an intervention and is a pedi- atric postmarket surveillance of a de- vice product
p.000140: (F) Primary Disease or Condition Being Studied, or the Focus of the Study. The name(s) of the
p.000140: disease(s) or condi- tion(s) being studied in the pediatric postmarket surveillance of a device
p.000140: product, or the focus of the surveil- lance study. Use, if available, appro- priate descriptors
p.000140: fromNLM’s MeSH- controlled vocabulary thesaurus or terms from another vocabulary, such as the SNOMED
p.000140: CT, that has been mapped to MeSH within the UMLS Metathesaurus.
p.000140: (G) Intervention Name(s). A brief de-
p.000140: scriptive name used to refer to each intervention studied in the pediatric postmarket surveillance of
p.000140: a device product. A non-proprietary name of the intervention must be used, if available. If a non-proprietary
p.000140: name is not avail- able, a brief descriptive name or identi- fier must be used.
p.000140: (H) Other Intervention Name(s). Any other current and former name(s) or alias(es), different from the
p.000140: Interven- tion Name(s), that the sponsor has used publicly to identify the intervention(s), including, but not
...
p.000141: of an expanded access record. If expanded ac- cess is available only as specified in 21 CFR 312.310 (for
p.000141: individual patients, in- cluding for emergency use) for an in- vestigational drug product (including a biological
p.000141: product) studied in an appli- cable drug clinical trial, and the data elements set forth in
p.000141: paragraphs (c)(1)(i), (iii), (iv), (vi), (ix), (x), (c)(2)(iv), (c)(3), (c)(4)(i), (iii),(iv),
p.000141: and
p.000141: (v) of this section have not been sub-
p.000141: mitted in an expanded access record for
p.000142: 142
p.000142:
p.000142:
p.000142:
p.000142:
p.000142:
p.000142:
p.000142:
p.000142: Public Health Service, HHS § 11.28
p.000142:
p.000142:
p.000142: that investigational product, the re- sponsible party, if both the manufac- turer of the
p.000142: investigational product and the sponsor of the applicable clin- ical trial, must submit the clinical
p.000142: trial information specified in those paragraphs to ClinicalTrials.gov in the form of an expanded access
p.000142: record.
p.000142: (1) Descriptive information:
p.000142: (i) Brief Title. A short title identi- fying the expanded access, written in language intended for the
p.000142: lay public. If an acronym or abbreviation is used publicly to identify the expanded ac- cess, it must be
p.000142: provided.
p.000142: (ii) Official Title. The title, if any, of the expanded access program cor- responding to the
p.000142: title that has been submitted to FDA for that program
p.000142: (iii) Brief Summary. A short descrip- tion of the availability of expanded ac- cess, including the procedure
p.000142: for re- questing the investigational drug prod- uct (including a biological product).
p.000142: (iv) Study Type. The nature of the in- vestigation or investigational use for which clinical trial
p.000142: information is being submitted, i.e., ‘‘expanded ac- cess’’.
p.000142: (v) Primary Disease or Condition. The name(s) of the disease(s) or condi- tion(s) for which
p.000142: expanded access to the investigational drug product (in- cluding a biological product) is avail- able.
p.000142: Use, if available, appropriate descriptors from NLM’s MeSH-con- trolled vocabulary thesaurus,
p.000142: or terms from another vocabulary, such as the SNOMED CT, that has been mapped to MeSH within
p.000142: the UMLS Metathesaurus.
p.000142: (vi) Intervention Name(s). A brief de- scriptive name used to refer to the in- vestigational drug product
p.000142: (including a biological product) that is available through expanded access. A non-propri- etary name of the
...
Social / Marital Status
Searching for indicator single:
(return to top)
p.000130: clinical trial must have one responsible party. With respect to a clinical trial, the sponsor of the
p.000130: clinical trial will be considered the responsible party unless and until a principal investigator has been
p.000130: des- ignated the responsible party, in ac- cordance with paragraph (c)(2) of this section. With
p.000130: respect to a pediatric postmarket surveillance of a device product that is not a clinical trial, the
p.000130: responsible party is the entity that the
p.000130: U.S. Food and Drug Adminstration (FDA), under section 522 of the Federal Food, Drug, and Cosmetic
p.000130: Act (21
p.000130: U.S.C. 3601), orders to conduct the pedi- atric postmarket surveillance of a de- vice product.
p.000130: (1) Determination of sponsor. For pur- poses of this part, each applicable clin- ical trial or other clinical
p.000130: trial must have one sponsor.
p.000130: (i) When an applicable clinical trial or other clinical trial is conducted under an investigational
p.000130: new drug ap- plication (IND) or investigational de- vice exemption (IDE), the IND or IDE holder will be
p.000130: considered the sponsor.
p.000130: (ii) When an applicable clinical trial or other clinical trial is not conducted under an IND or IDE, the
p.000130: single person or entity who initiates the trial, by preparing and/or planning the trial, and who
p.000130: has authority and control over the trial, will be considered the spon- sor.
p.000130: (2) Designation of a principal investi- gator as the responsible party.
p.000130: (i) The sponsor may designate a prin- cipal investigator as the responsible party if such principal
p.000130: investigator meets all of the following require- ments:
p.000130: (A) Is responsible for conducting the trial;
p.000130: (B) Has access to and control over the data from the trial;
p.000130: (C) Has the right to publish the re- sults of the trial; and
p.000130: (D) Has the ability to meet all of the requirements for submitting and up- dating clinical trial
p.000130: information as specified in this part.
p.000131: 131
p.000131:
p.000131:
p.000131:
p.000131:
p.000131:
p.000131:
p.000131:
p.000131:
p.000131: § 11.6
p.000131: (ii) With regard to an applicable clin- ical trial or other clinical trial, a des- ignation by the sponsor
p.000131: under para- graph (c)(2)(i) of this section shall con- sist of the sponsor obtaining from the principal
p.000131: investigator an acknowledg- ment of the principal investigator’s re- sponsibilities under this part as respon- sible
p.000131: party, and the principal investi- gator acknowledging the designation as responsible party to the
...
Social / Property Ownership
Searching for indicator home:
(return to top)
p.000134: or interventions under investigation in a clinical trial and is not specified as an exploratory or other
p.000134: measure. A clinical trial may have more than one secondary outcome measure. For purposes of this part,
p.000134: ‘‘secondary outcome’’ has the same meaning as secondary outcome meas- ure.
p.000134: Secretary means the Secretary of
p.000134: Health and Human Services or any other official(s) to whom the Secretary delegates the authority
p.000134: contained in section 402(j) of the Public Health Service Act (42 U.S.C. 282(j)).
p.000134: Serious adverse event means an ad- verse event that results in any of the following outcomes:
p.000134: Death, a life- threatening adverse event as defined in 21 CFR 312.32, inpatient hospitalization or prolongation
p.000134: of existing hospitaliza- tion, a persistent or significant inca- pacity or substantial disruption of the
p.000134: ability to conduct normal life func- tions, or a congenital anomaly/birth defect. Important medical
p.000134: events that may not result in death, be life-threat- ening, or require hospitalization may be considered serious
p.000134: when, based upon appropriate medical judgment, they may jeopardize the human subject and may require
p.000134: medical or surgical inter- vention to prevent one of the outcomes listed in this definition. Examples of such
p.000134: medical events include allergic bronchospasm requiring intensive treatment in an emergency room
p.000134: or at home, blood dyscrasias or convulsions that do not result in inpatient hos- pitalization, or
p.000134: the development of a substance use disorder.
p.000134: Sponsor means either a ‘‘sponsor’’ or
p.000134: ‘‘sponsor-investigator,’’ as each is de- fined in 21 CFR 50.3.
p.000134: Study completion date means, for a clinical trial, the date the final subject was examined or received an
p.000134: interven- tion for purposes of final collection of data for the primary and secondary outcome
p.000134: measures and adverse events
p.000134:
p.000134: (e.g., last subject’s last visit), whether the clinical trial concluded according to the pre-specified
p.000134: protocol or was ter- minated.
p.000134: U.S. FDA-regulated device product means, for purposes of this part, a de- vice product subject to
p.000134: section 510(k), 515, 520(m), or 522 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360(k),
p.000134: 21 U.S.C. 360e, 21 U.S.C. 360j(m), 21 U.S.C. 360l).
p.000134: U.S. FDA-regulated drug product means, for purposes of this part, a drug product subject to section
p.000134: 505 of the Federal Food, Drug, and Cosmetic Act or a biological product subject to sec- tion 351 of the
p.000134: Public Health Service Act (21 U.S.C. 355, 42 U.S.C. 262) .
p.000134: (b) The following definitions apply to data elements of clinical trial informa- tion referenced in this part, unless
p.000134: oth- erwise specified:
...
Social / Racial Minority
Searching for indicator race:
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p.000147: and baseline measures and data collected by arm or comparison group and for the entire population
p.000147: of human subjects who par- ticipated in the clinical trial. This in- formation must include the following
p.000147: elements:
p.000147: (i) Baseline Characteristics Arm/Group Information. A brief description of each arm or comparison group
p.000147: used for de- scribing the demographic and baseline characteristics of the human subjects in the clinical
p.000147: trial, including a de- scriptive title used to identify each arm or comparison group.
p.000147: (ii) Baseline Analysis Population Infor- mation—(A) Overall Number of Baseline Participants. The total
p.000147: number of human subjects for whom baseline characteristics were measured, by arm or comparison group
p.000147: and overall.
p.000147: (B) Overall Number of Units Analyzed. If the analysis is based on a unit other than participants, a description
p.000147: of the unit of analysis and the number of units for which baseline measures were measured and analyzed,
p.000147: by arm or com- parison group and overall.
p.000147: (C) Analysis Population Description. If the Overall Number of Baseline Par- ticipants (or units) differs
p.000147: from the number of human subjects (or units) assigned to the arm or comparison group and overall, a
p.000147: brief description of the reason(s) for the difference.
p.000147: (iii) Baseline Measure Information. A description of each baseline or demo- graphic characteristic
p.000147: measured in the clinical trial, including age, sex/gender, race, ethnicity (if collected under the
p.000148: 148
p.000148:
p.000148:
p.000148:
p.000148:
p.000148:
p.000148:
p.000148:
p.000148: Public Health Service, HHS § 11.48
p.000148:
p.000148:
p.000148: protocol), and any other measure(s) that were assessed at baseline and are used in the analysis
p.000148: of the primary outcome measure(s) in accordance with
p.000148: § 11.48(a)(3). The description of each measure must include the following elements:
p.000148: (A) Name and description of the measure, including any categories that are used to submit Baseline
p.000148: Measure Data.
p.000148: (B) Measure Type and Measure of Dis- persion: For each baseline measure sub- mitted, an indication of
p.000148: the type of data to be submitted and the associ- ated measure of dispersion.
p.000148: (C) Unit of Measure. For each baseline measure for which data are collected, the unit of measure.
p.000148: (iv) Baseline Measure Data. The value(s) for each submitted baseline measure, by arm or
p.000148: comparison group and for the entire population of human subjects for whom baseline characteris- tics were measured.
p.000148: (v) Number of baseline participants (and units), by arm or comparison group and overall, if different
p.000148: from the Overall Number of Baseline Partici- pants or Overall Number of Units Ana- lyzed in §
p.000148: 11.48(a)(2)(ii)(A) and (B), re- spectively.
p.000148: (3) Outcomes and statistical analyses. Information for completing a table of data for each primary and
p.000148: secondary outcome measure by arm or compari- son group, including the result(s) of scientifically
...
Social / Threat of Stigma
Searching for indicator threat:
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p.000134:
p.000134: Public Health Service, HHS § 11.10
p.000134:
p.000134:
p.000134: trial, the responsible party is the enti- ty who FDA orders to conduct the pedi- atric postmarket
p.000134: surveillance of the device product.
p.000134: Secondary outcome measure means an outcome measure that is of lesser im- portance than a primary
p.000134: outcome measure, but is part of a pre-specified analysis plan for evaluating the effects of the intervention
p.000134: or interventions under investigation in a clinical trial and is not specified as an exploratory or other
p.000134: measure. A clinical trial may have more than one secondary outcome measure. For purposes of this part,
p.000134: ‘‘secondary outcome’’ has the same meaning as secondary outcome meas- ure.
p.000134: Secretary means the Secretary of
p.000134: Health and Human Services or any other official(s) to whom the Secretary delegates the authority
p.000134: contained in section 402(j) of the Public Health Service Act (42 U.S.C. 282(j)).
p.000134: Serious adverse event means an ad- verse event that results in any of the following outcomes:
p.000134: Death, a life- threatening adverse event as defined in 21 CFR 312.32, inpatient hospitalization or prolongation
p.000134: of existing hospitaliza- tion, a persistent or significant inca- pacity or substantial disruption of the
p.000134: ability to conduct normal life func- tions, or a congenital anomaly/birth defect. Important medical
p.000134: events that may not result in death, be life-threat- ening, or require hospitalization may be considered serious
p.000134: when, based upon appropriate medical judgment, they may jeopardize the human subject and may require
p.000134: medical or surgical inter- vention to prevent one of the outcomes listed in this definition. Examples of such
p.000134: medical events include allergic bronchospasm requiring intensive treatment in an emergency room
p.000134: or at home, blood dyscrasias or convulsions that do not result in inpatient hos- pitalization, or
p.000134: the development of a substance use disorder.
p.000134: Sponsor means either a ‘‘sponsor’’ or
p.000134: ‘‘sponsor-investigator,’’ as each is de- fined in 21 CFR 50.3.
p.000134: Study completion date means, for a clinical trial, the date the final subject was examined or received an
p.000134: interven- tion for purposes of final collection of data for the primary and secondary outcome
p.000134: measures and adverse events
p.000134:
p.000134: (e.g., last subject’s last visit), whether the clinical trial concluded according to the pre-specified
p.000134: protocol or was ter- minated.
p.000134: U.S. FDA-regulated device product means, for purposes of this part, a de- vice product subject to
p.000134: section 510(k), 515, 520(m), or 522 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360(k),
p.000134: 21 U.S.C. 360e, 21 U.S.C. 360j(m), 21 U.S.C. 360l).
...
p.000138: (A) At least one Facility Location for the clinical trial is within the United States or one of its territories,
p.000138: (B) A drug product (including a bio- logical product) under investigation is a Product Manufactured in
p.000138: and Ex- ported from the U.S. or one of its terri- tories for study in another country, or
p.000138: (C) The clinical trial has a U.S. Food and Drug Administration IND Number.
p.000138:
p.000138: § 11.24 When must clinical trial reg- istration information be submitted?
p.000138: (a) General. Except as provided in paragraph (b) of this section, the re- sponsible party for an
p.000138: applicable clin- ical trial for which submission of clin- ical trial registration information is
p.000138: required must submit the clinical trial registration information specified in section 402(j)(2)(A)(ii)
p.000138: of the Public Health Service Act (42 U.S.C. 282(j)(2)(A)(ii)) or § 11.28(a), as applica-
p.000138: ble, not later than December 26, 2007, or 21 calendar days after the first human subject is
p.000138: enrolled, whichever date is later.
p.000138: (b) Exceptions:. (1) The responsible party for an applicable clinical trial that is a clinical
p.000138: trial and for which
p.000139: 139
p.000139:
p.000139:
p.000139:
p.000139:
p.000139:
p.000139:
p.000139:
p.000139:
p.000139: § 11.28
p.000139: the submission of clinical trial reg- istration information is required and that is not for a
p.000139: serious or life-threat- ening disease or condition must submit clinical trial registration information as
p.000139: specified in section 402(j)(2)(A)(ii) of the Public Health Service Act (42 U.S.C.
p.000139: 282(j)(2)(A)(ii)) or § 11.28(a), as
p.000139: applicable, not later than September 27, 2008, or 21 calendar days after the first human subject is
p.000139: enrolled, which- ever date is later.
p.000139: (2) The responsible party for an appli- cable device clinical trial that is a pe- diatric postmarket
p.000139: surveillance of a device product and is not a clinical trial must submit clinical trial reg-
p.000139: istration information, as specified in section 402(j)(2)(A)(ii) of the Public Health Service
p.000139: Act (42 U.S.C. 282(j)(2)(A)(ii)) or § 11.28(b), not later than December 26, 2007, or 21
p.000139: calendar days after FDA approves the postmarket surveillance plan, which- ever date is later.
p.000139: § 11.28 What constitutes clinical trial registration information?
p.000139: (a) For each applicable clinical trial that must be registered with ClinicalTrials.gov, other
p.000139: than a pedi- atric postmarket surveillance of a de- vice product that is not a clinical trial, the responsible
p.000139: party must submit the following information:
p.000139: (1) For such applicable clinical trials that were initiated before January 18, 2017, the responsible party
p.000139: must submit the information specified in section 402(j)(2)(A)(ii) of the Public Health Service Act
p.000139: (42 U.S.C. 282(j)(2)(A)(ii)).
...
Social / gender
Searching for indicator gender:
(return to top)
p.000135: the primary com- pletion date, the responsible party must update the Enrollment data ele- ment to
p.000135: reflect the actual number of human subjects enrolled in the clinical trial.
p.000136: 136
p.000136:
p.000136:
p.000136:
p.000136:
p.000136:
p.000136:
p.000136:
p.000136: Public Health Service, HHS § 11.10
p.000136:
p.000136:
p.000136: (19) Primary Outcome Measure Informa- tion means a description of each pri- mary outcome measure, to include
p.000136: the following information:
p.000136: (i) Name of the specific primary out- come measure;
p.000136: (ii) Description of the metric used to characterize the specific primary out- come measure; and
p.000136: (iii) Time point(s) at which the meas- urement is assessed for the specific metric used.
p.000136: (20) Secondary Outcome Measure Infor- mation means a description of each sec- ondary outcome measure, to
p.000136: include the following information:
p.000136: (i) Name of the specific secondary outcome measure;
p.000136: (ii) Description of the metric used to characterize the specific secondary outcome measure; and
p.000136: (iii) Time point(s) at which the meas- urement is assessed for the specific metric used.
p.000136: (21) Eligibility Criteria means a limited list of criteria for selection of human subjects to participate in
p.000136: the clinical trial, provided in terms of inclusion and exclusion criteria and suitable for assisting
p.000136: potential human subjects in identifying clinical trials of interest.
p.000136: (22) Sex/Gender means the sex and, if applicable, gender of the human sub- jects who may participate in
p.000136: the clin- ical trial.
p.000136: (23) Age Limits means the minimum and maximum age of human subjects who may participate in the
p.000136: clinical trial, provided in relevant units of time.
p.000136: (24) Accepts Healthy Volunteers means that human subjects who do not have a disease or condition, or related
p.000136: condi- tions or symptoms, under study in the clinical trial are permitted to partici- pate in the clinical
p.000136: trial.
p.000136: (25) Overall Recruitment Status means the recruitment status for the clinical trial as a whole, based on the
p.000136: status of the individual sites. If at least one fa- cility in a multi-site clinical trial has an
p.000136: individual site status of ‘‘recruit- ing,’’ then the overall recruitment sta- tus for the trial must be
p.000136: ‘‘recruiting.’’
p.000136: (26) Why Study Stopped means, for a clinical trial that is suspended or ter- minated or withdrawn
p.000136: prior to its planned completion as anticipated by the protocol, a brief explanation of the
p.000136:
p.000136: reason(s) why the clinical trial was stopped.
p.000136: (27) Individual Site Status means the recruitment status of each partici- pating facility in a
p.000136: clinical trial.
p.000136: (28) Availability of Expanded Access means, for an applicable drug clinical trial of a drug product
...
p.000139: (J) Intervention Name(s), for each intervention studied;
p.000139: (K) Other Intervention Name(s), for each intervention studied;
p.000139: (L) Intervention Description, for each intervention studied;
p.000139: (M) Intervention Type, for each intervention studied;
p.000139: (N) Studies a U.S. FDA-regulated De- vice Product;
p.000139: (O) Studies a U.S. FDA-regulated Drug Product;
p.000139: (P) Device Product Not Approved or Cleared by U.S. FDA, if any studied intervention is a device product;
p.000139: (Q) Post Prior to U.S. FDA Approval or Clearance, for an applicable device clinical trial that studies
p.000139: at least one device product not previously approved or cleared by the U.S. FDA;
p.000139: (R) Product Manufactured in and Ex- ported from the U.S., if the entry for
p.000139: U.S. Food and Drug Administration IND or IDE Number in
p.000139: § 11.28(a)(2)(iv)(C) indicates that there is no IND or IDE for the clinical trial, and the entry(ies) for
p.000139: Facility Informa- tion in § 11.28(a)(2)(iii)(C) include no fa- cility locations in the United States or its
p.000139: territories;
p.000139: (S) Study Start Date;
p.000139: (T) Primary Completion Date;
p.000139: (U) Study Completion Date;
p.000139: (V) Enrollment;
p.000139: (W) Primary Outcome Measure Infor- mation, for each primary outcome measure; and
p.000139: (X) Secondary Outcome Measure In- formation, for each secondary outcome measure.
p.000139: (ii) Recruitment information:
p.000139: (A) Eligibility Criteria;
p.000139: (B) Sex/Gender;
p.000139: (C) Age Limits;
p.000139: (D) Accepts Healthy Volunteers;
p.000139: (E) Overall Recruitment Status;
p.000139: (F) Why Study Stopped;
p.000139: (G) Individual Site Status; and
p.000139: (H) Availability of Expanded Access. If expanded access is available for an investigational drug product
p.000139: (including a biological product), an expanded ac- cess record must be submitted in ac- cordance with §
p.000139: 11.28(c), unless an ex- panded access record was submitted
p.000140: 140
p.000140:
p.000140:
p.000140:
p.000140:
p.000140:
p.000140:
p.000140:
p.000140: Public Health Service, HHS § 11.28
p.000140:
p.000140:
p.000140: previously in accordance with that pro- vision.
p.000140: (iii) Location and contact informa- tion:
p.000140: (A) Name of the Sponsor;
p.000140: (B) Responsible Party, by Official Title; and
p.000140: (C) Facility Information.
p.000140: (iv) Administrative data:
p.000140: (A) Unique Protocol Identification Number;
p.000140: (B) Secondary ID;
p.000140: (C) U.S. Food and Drug Administra- tion IND or IDE Number;
p.000140: (D) Human Subjects Protection Re- view Board Status;
p.000140: (E) Record Verification Date; and
...
p.000142: the Interven- tion Name(s) or Other Intervention Name(s), sufficient to distinguish the intervention from
p.000142: other, similar inter- ventions that are available through ex- panded access or in clinical trials.
p.000142: (ix) Intervention Type. For each inves- tigational drug product (including a bi- ological product) for which
p.000142: expanded access is available, the general type of intervention, e.g., drug.
p.000142: (x) Expanded Access Type. The type(s) of expanded access for which the inves- tigational drug product (including a
p.000142: bi- ological product) is available, as speci- fied in § 11.10(b)(28).
p.000142: (2) Recruitment information:
p.000142: (i) Eligibility Criteria. A limited list of criteria for determining who is eligible to receive the
p.000142: investigational drug product (including a biological prod- uct) through expanded access, provided in terms
p.000142: of inclusion and exclusion cri- teria and suitable for assisting poten- tial patients in identifying
p.000142: investiga- tional drug products (including biologi- cal products) of interest for which ex- panded access is
p.000142: available.
p.000142: (ii) Sex/Gender. The sex and gender (if applicable) of the patients for whom expanded access is available.
p.000142: (iii) Age Limits. The minimum and maximum age of patients for whom ex- panded access is available,
p.000142: provided in relevant units of time.
p.000142: (iv) Expanded Access Status. The sta- tus of availability of the investiga- tional drug product
p.000142: (including a bio- logical product) through expanded ac- cess.
p.000142: (3) Contact information:
p.000142: (i) Name of the Sponsor.
p.000142: (ii) Responsible Party, by Official Title.
p.000142: The official name of the entity.
p.000142: (iii) Contact Information. The name or official title, toll-free telephone num- ber, and email address of a
p.000142: person to whom questions concerning expanded access can be addressed.
p.000142: (4) Administrative data:
p.000142: (i) Unique Protocol Identification Num- ber. Any unique identifier assigned by the sponsor to refer to
p.000142: the availability of its investigational drug product (in- cluding a biological product) for ex- panded
p.000142: access use or to identify the ex- panded access record.
p.000143: 143
p.000143:
p.000143:
p.000143:
p.000143:
p.000143:
p.000143:
p.000143:
p.000143:
p.000143: § 11.35
...
p.000147: and baseline measures and data collected by arm or comparison group and for the entire population
p.000147: of human subjects who par- ticipated in the clinical trial. This in- formation must include the following
p.000147: elements:
p.000147: (i) Baseline Characteristics Arm/Group Information. A brief description of each arm or comparison group
p.000147: used for de- scribing the demographic and baseline characteristics of the human subjects in the clinical
p.000147: trial, including a de- scriptive title used to identify each arm or comparison group.
p.000147: (ii) Baseline Analysis Population Infor- mation—(A) Overall Number of Baseline Participants. The total
p.000147: number of human subjects for whom baseline characteristics were measured, by arm or comparison group
p.000147: and overall.
p.000147: (B) Overall Number of Units Analyzed. If the analysis is based on a unit other than participants, a description
p.000147: of the unit of analysis and the number of units for which baseline measures were measured and analyzed,
p.000147: by arm or com- parison group and overall.
p.000147: (C) Analysis Population Description. If the Overall Number of Baseline Par- ticipants (or units) differs
p.000147: from the number of human subjects (or units) assigned to the arm or comparison group and overall, a
p.000147: brief description of the reason(s) for the difference.
p.000147: (iii) Baseline Measure Information. A description of each baseline or demo- graphic characteristic
p.000147: measured in the clinical trial, including age, sex/gender, race, ethnicity (if collected under the
p.000148: 148
p.000148:
p.000148:
p.000148:
p.000148:
p.000148:
p.000148:
p.000148:
p.000148: Public Health Service, HHS § 11.48
p.000148:
p.000148:
p.000148: protocol), and any other measure(s) that were assessed at baseline and are used in the analysis
p.000148: of the primary outcome measure(s) in accordance with
p.000148: § 11.48(a)(3). The description of each measure must include the following elements:
p.000148: (A) Name and description of the measure, including any categories that are used to submit Baseline
p.000148: Measure Data.
p.000148: (B) Measure Type and Measure of Dis- persion: For each baseline measure sub- mitted, an indication of
p.000148: the type of data to be submitted and the associ- ated measure of dispersion.
p.000148: (C) Unit of Measure. For each baseline measure for which data are collected, the unit of measure.
p.000148: (iv) Baseline Measure Data. The value(s) for each submitted baseline measure, by arm or
p.000148: comparison group and for the entire population of human subjects for whom baseline characteris- tics were measured.
p.000148: (v) Number of baseline participants (and units), by arm or comparison group and overall, if different
p.000148: from the Overall Number of Baseline Partici- pants or Overall Number of Units Ana- lyzed in §
p.000148: 11.48(a)(2)(ii)(A) and (B), re- spectively.
p.000148: (3) Outcomes and statistical analyses. Information for completing a table of data for each primary and
...
p.000150: between the sponsor or its agent and the principal investigator that re- stricts in any manner the ability of
p.000150: the principal investigator, after the pri- mary completion date of the clinical trial, to discuss the
p.000150: results of the clin- ical trial at a scientific meeting or any
p.000150:
p.000150: other public or private forum or to publish in a scientific or academic journal information
p.000150: concerning the re- sults of the clinical trial
p.000150: (7) Additional clinical trial results infor- mation for applicable device clinical trials of unapproved or
p.000150: uncleared device prod- ucts. (i) For an applicable device clin- ical trial of an unapproved or uncleared device
p.000150: product and for which clinical trial registration information has not been posted publicly on
p.000150: Clinical Trials.gov by the Director in accord- ance with § 11.35(b)(2)(i), the responsible party must provide
p.000150: the following data elements, as the data elements are de- fined in § 11.10(b): Brief Title; Official
p.000150: Title; Brief Summary; Primary Pur- pose; Study Design; Study Type; Pri- mary Disease or Condition Being
p.000150: Stud- ied in the Trial, or the Focus of the Study; Intervention Name(s); Other Intervention Name(s);
p.000150: Intervention De- scription; Intervention Type; Device Product Not Approved or Cleared by
p.000150: U.S. FDA, if any studied intervention is a device product; Study Start Date; Primary Completion Date; Study
p.000150: Com- pletion Date, Enrollment; Primary Outcome Measure Information; Sec- ondary Outcome Measure
p.000150: Information; Eligibility Criteria; Sex/Gender; Age Limits; Accepts Healthy Volunteers; Overall
p.000150: Recruitment Status; Why Study Stopped; Name of the Sponsor; Responsible Party, by Official Title;
p.000150: Facility Name and Facility Location, for each participating facility in a clin- ical trial; Unique Protocol
p.000150: Identifica- tion Number; Secondary ID; Human Subjects Protection Review Board Sta- tus; and Record Verification
p.000150: Date.
p.000150: (ii) The responsible party shall sub-
p.000150: mit all the results information speci- fied in paragraph (a)(7)(i) and must sub- mit an affirmation that any
p.000150: informa- tion previously submitted to ClinicalTrials.gov for the data elements listed in
p.000150: paragraph (a)(7)(i) of this sec- tion have been updated in accordance with § 11.64(a) and are to be included
p.000150: as clinical trial results information.
p.000150: (b) Pediatric postmarket surveillance of
p.000150: a device product that is not a clinical trial. For each pediatric postmarket surveillance of a
p.000150: device product that is not a clinical trial, the responsible party must submit a copy of any final
p.000150: report that is submitted to FDA as
p.000151: 151
p.000151:
p.000151:
p.000151:
p.000151:
p.000151:
p.000151:
p.000151:
p.000151:
p.000151: § 11.52
p.000151: specified in 21 CFR 822.38. The respon- sible party may redact names, address- es, and other personally
...
p.000154: clinical trial for which the clinical trial registration informa- tion specified in section 402(j)(2)(A)(ii)
p.000154: of the Public Health Service Act (42
p.000154: U.S.C. 282(j)(2)(A)(ii)) has not been sub- mitted, the responsible party must sub- mit the data elements
p.000154: specified in
p.000154: § 11.48, as well as the data elements listed below, as those data elements are defined in §
p.000154: 11.10(b) and apply to the clinical trial and the intervention(s) studied: Brief Title; Official Title; Brief
p.000154:
p.000154: Summary; Primary Purpose; Study De- sign; Study Phase, for a clinical trial of a drug product (including a
p.000154: biological product); Study Type; Pediatric Postmarket Surveillance of a Device Product; Primary
p.000154: Disease or Condition Being Studied in the Trial, or the Focus of the Study; Intervention
p.000154: Name(s), for each intervention studied; Other Intervention Name(s), for each intervention studied; Intervention
p.000154: De- scription, for each intervention stud- ied; Intervention Type, for each inter- vention studied; Device
p.000154: Product Not Approved or Cleared by U.S. FDA, if any studied intervention is a device product;
p.000154: Product Manufactured in and Exported from the U.S.; Studies a U.S. FDA-regulated Device Product; Studies a
p.000154: U.S. FDA-regulated Drug Product; Study Start Date; Primary Completion Date; Study Completion Date; Enroll-
p.000154: ment; Eligibility Criteria; Sex/Gender; Age Limits; Accepts Healthy Volun- teers; Overall Recruitment
p.000154: Status; Why Study Stopped; Availability of Ex- panded Access, if any studied interven- tion is an investigational
p.000154: drug product (including a biological product); Name of the Sponsor; Responsible Party, by Official Title;
p.000154: Facility Information, for each participating facility; Unique Protocol Identification Number; Sec-
p.000154: ondary ID; U.S. Food and Drug Admin- istration IND or IDE Number; Human Subjects Protection Review Board Sta- tus;
p.000154: Record Verification Date; and Re- sponsible Party Contact Information.
p.000154: (C) If the responsible party both vol-
p.000154: untarily submits clinical trial registra- tion information and voluntarily sub- mits clinical trial results
p.000154: information, the responsible party must submit both the clinical trial registration informa- tion specified in
p.000154: section 402(j)(2)(A)(ii) of the Public Health Service Act (42
p.000154: U.S.C. 282(j)(2)(A)(ii)) and the clinical trial results information specified in
p.000154: § 11.48.
p.000154: (ii) If, on or after September 27, 2007, a manufacturer submits an application or premarket notification to
...
Social / orphan
Searching for indicator orphan:
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p.000130:
p.000130:
p.000130:
p.000130:
p.000130:
p.000130:
p.000130:
p.000130:
p.000130:
p.000130:
p.000130:
p.000130:
p.000130:
p.000130:
p.000130: Pt. 11
p.000130: purchase of any covered outpatient drug.
p.000130: (2) A covered entity that is a free- standing cancer hospital cannot use a GPO to purchase orphan
p.000130: drugs when they are transferred, prescribed, sold, or otherwise used for an indication other than the
p.000130: rare condition or dis- ease for which that orphan drug was designated under section 526 of the
p.000130: FFDCA.
p.000130: (3) A covered entity that is a free- standing cancer hospital may use a GPO for purchasing orphan
p.000130: drugs when orphan drugs are transferred, pre- scribed, sold, or otherwise used for the rare disease
p.000130: or condition for which it was designated under section 526 of the FFDCA.
p.000130: (4) If a covered entity that is a free- standing cancer hospital chooses to use a GPO for purchasing an
p.000130: orphan drug used for a rare disease or condition for which it is designated, it is required to maintain
p.000130: auditable records that dem- onstrate full compliance with the or- phan drug purchasing requirements
p.000130: and limitations. A free-standing cancer hospital covered entity that cannot or does not wish to maintain
p.000130: auditable records sufficient to demonstrate com- pliance, must notify HRSA and pur- chase all orphan
p.000130: drugs outside of the 340B Program, regardless of indication for which the drug is used, and is not
p.000130: permitted to use a GPO to purchase those drugs. Once a free-standing can- cer hospital is enrolled in
p.000130: 340B, it may change its decision to purchase all or- phan drugs outside of the 340B Program on a
p.000130: quarterly basis by notifying HRSA. This documentation will be made public. This information will
p.000130: also be verified during the annual recertifi- cation process.
p.000130: (e) Identification of orphan drugs. Des- ignations under section 526 of the FFDCA are the
p.000130: responsibility of and administered by the FDA. Only covered outpatient drugs that match the list- ing and
p.000130: sponsor of the orphan designa- tion are considered orphan drugs for purposes of this section. HRSA
p.000130: will publish on its public Web site FDA’s section 526 list of drugs that will gov- ern the next quarter’s
p.000130: purchases.
p.000130: (f) Failure to comply. Failure to com- ply with this section shall be consid-
p.000130:
p.000130: 42 CFR Ch. I (10–1–16 Edition)
p.000130: ered a violation of sections 340B(a)(5) and 340B(e) of the PHSA, as applicable.
p.000130:
p.000130: PART 11—CLINICAL TRIALS REG- ISTRATION AND RESULTS INFOR- MATION SUBMISSION (Eff. 1-18- 17)
p.000130: Subpart A—General Provisions
p.000130: Sec.
p.000130: 11.2 What is the purpose of this part?
p.000130: 11.4 To whom does this part apply?
p.000130: 11.6 What are the requirements for the sub- mission of truthful information?
p.000130: 11.8 In what format must clinical trial in- formation be submitted?
p.000130: 11.10 What definitions apply to this part?
p.000130: Subpart B—Registration
p.000130: 11.20 Who must submit clinical trial reg- istration information?
p.000130: 11.22 Which applicable clinical trials must be registered?
p.000130: 11.24 When must clinical trial registration information be submitted?
p.000130: 11.28 What constitutes clinical trial reg- istration information?
p.000130: 11.35 By when will the NIH Director post clinical trial registration information submitted under §
p.000130: 11.28?
p.000130: Subpart C—Results Information Submission
p.000130: 11.40 Who must submit clinical trial results information?
p.000130: 11.42 For which applicable clinical trials must clinical trial results information be submitted?
p.000130: 11.44 When must clinical trial results infor- mation be submitted for applicable clin- ical trials subject
p.000130: to § 11.42?
...
General/Other / Other Country
Searching for indicator another country:
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p.000135: available, a brief descriptive name or identifier must be used.
p.000135: (11) Other Intervention Name(s) means other current and former name(s) or alias(es), if any, different
p.000135: from the Intervention Name(s), that the sponsor has used publicly to identify the inter-
p.000135: 42 CFR Ch. I (10–1–16 Edition)
p.000135: vention(s), including, but not limited to, past or present names such as brand name(s), or serial numbers.
p.000135: (12) Intervention Description means de- tails that can be made public about the intervention, other than the
p.000135: Interven- tion Name(s) and Other Intervention Name(s), sufficient to distinguish the intervention from
p.000135: other, similar inter- ventions studied in the same or an- other clinical trial. For example, inter-
p.000135: ventions involving drugs may include dosage form, dosage, frequency, and du- ration.
p.000135: (13) Intervention Type means, for each intervention studied in the clinical trial, the general type of
p.000135: intervention, e.g., drug, biological/vaccine, or, de- vice.
p.000135: (14) Device Product Not Approved or Cleared by U.S. FDA means that at least one device product
p.000135: studied in the clinical trial has not been previously approved or cleared by FDA for one or more uses.
p.000135: (15) Product Manufactured in and Ex- ported from the U.S. means that any drug product (including
p.000135: a biological product) or device product studied in the clinical trial is manufactured in the United
p.000135: States or one of its terri- tories and exported for study in a clin- ical trial in another country.
p.000135: (16) Study Start Date means the esti- mated date on which the clinical trial will be open for
p.000135: recruitment of human subjects, or the actual date on which the first human subject was enrolled.
p.000135: (17) Primary Completion Date means the estimated or actual primary com- pletion date. If an estimated
p.000135: primary completion date is used, the respon- sible party must update the Primary Completion Date
p.000135: data element once the clinical trial has reached the pri- mary completion date to reflect the ac- tual
p.000135: primary completion date.
p.000135: (18) Enrollment means the estimated total number of human subjects to be enrolled (target number) or the
p.000135: actual total number of human subjects that are enrolled in the clinical trial. Once the trial has reached
p.000135: the primary com- pletion date, the responsible party must update the Enrollment data ele- ment to
p.000135: reflect the actual number of human subjects enrolled in the clinical trial.
p.000136: 136
p.000136:
p.000136:
p.000136:
p.000136:
p.000136:
p.000136:
p.000136:
p.000136: Public Health Service, HHS § 11.10
p.000136:
p.000136:
p.000136: (19) Primary Outcome Measure Informa- tion means a description of each pri- mary outcome measure, to include
p.000136: the following information:
p.000136: (i) Name of the specific primary out- come measure;
p.000136: (ii) Description of the metric used to characterize the specific primary out- come measure; and
p.000136: (iii) Time point(s) at which the meas- urement is assessed for the specific metric used.
...
General/Other / Public Emergency
Searching for indicator emergency:
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p.000134: outcome measure, but is part of a pre-specified analysis plan for evaluating the effects of the intervention
p.000134: or interventions under investigation in a clinical trial and is not specified as an exploratory or other
p.000134: measure. A clinical trial may have more than one secondary outcome measure. For purposes of this part,
p.000134: ‘‘secondary outcome’’ has the same meaning as secondary outcome meas- ure.
p.000134: Secretary means the Secretary of
p.000134: Health and Human Services or any other official(s) to whom the Secretary delegates the authority
p.000134: contained in section 402(j) of the Public Health Service Act (42 U.S.C. 282(j)).
p.000134: Serious adverse event means an ad- verse event that results in any of the following outcomes:
p.000134: Death, a life- threatening adverse event as defined in 21 CFR 312.32, inpatient hospitalization or prolongation
p.000134: of existing hospitaliza- tion, a persistent or significant inca- pacity or substantial disruption of the
p.000134: ability to conduct normal life func- tions, or a congenital anomaly/birth defect. Important medical
p.000134: events that may not result in death, be life-threat- ening, or require hospitalization may be considered serious
p.000134: when, based upon appropriate medical judgment, they may jeopardize the human subject and may require
p.000134: medical or surgical inter- vention to prevent one of the outcomes listed in this definition. Examples of such
p.000134: medical events include allergic bronchospasm requiring intensive treatment in an emergency room
p.000134: or at home, blood dyscrasias or convulsions that do not result in inpatient hos- pitalization, or
p.000134: the development of a substance use disorder.
p.000134: Sponsor means either a ‘‘sponsor’’ or
p.000134: ‘‘sponsor-investigator,’’ as each is de- fined in 21 CFR 50.3.
p.000134: Study completion date means, for a clinical trial, the date the final subject was examined or received an
p.000134: interven- tion for purposes of final collection of data for the primary and secondary outcome
p.000134: measures and adverse events
p.000134:
p.000134: (e.g., last subject’s last visit), whether the clinical trial concluded according to the pre-specified
p.000134: protocol or was ter- minated.
p.000134: U.S. FDA-regulated device product means, for purposes of this part, a de- vice product subject to
p.000134: section 510(k), 515, 520(m), or 522 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360(k),
p.000134: 21 U.S.C. 360e, 21 U.S.C. 360j(m), 21 U.S.C. 360l).
p.000134: U.S. FDA-regulated drug product means, for purposes of this part, a drug product subject to section
p.000134: 505 of the Federal Food, Drug, and Cosmetic Act or a biological product subject to sec- tion 351 of the
p.000134: Public Health Service Act (21 U.S.C. 355, 42 U.S.C. 262) .
p.000134: (b) The following definitions apply to data elements of clinical trial informa- tion referenced in this part, unless
p.000134: oth- erwise specified:
...
p.000136: prior to its planned completion as anticipated by the protocol, a brief explanation of the
p.000136:
p.000136: reason(s) why the clinical trial was stopped.
p.000136: (27) Individual Site Status means the recruitment status of each partici- pating facility in a
p.000136: clinical trial.
p.000136: (28) Availability of Expanded Access means, for an applicable drug clinical trial of a drug product
p.000136: (including a bio- logical product) that is not an ap- proved drug product (including a bio- logical
p.000136: product), and for which the re- sponsible party is both the manufac- turer of the drug product
p.000136: (including a biological product) and the sponsor of the applicable clinical trial:
p.000136: (i) An indication of whether there is expanded access to the investigational drug product (including a
p.000136: biological product) under section 561 of the Fed- eral Food, Drug, and Cosmetic Act (21
p.000136: U.S.C. 360bbb) for those individuals who do not qualify for enrollment in the applicable clinical
p.000136: trial, under one or more of the following types of ex- panded access programs: for individual patients,
p.000136: including for emergency use, as specified in 21 CFR 312.310; for inter- mediate-size patient populations, as
p.000136: specified in 21 CFR 312.315; or under a treatment IND or treatment protocol, as specified in 21 CFR 312.320;
p.000136: and
p.000136: (ii) If expanded access is available under section 561 of the Federal Food, Drug, and Cosmetic
p.000136: Act (21 U.S.C. 360bbb), the NCT number of the ex- panded access record.
p.000136: (29) Name of the Sponsor means the name of the entity or individual who is the sponsor of the clinical
p.000136: trial, as de- fined in this part.
p.000136: (30) Responsible Party, by Official Title
p.000136: means an:
p.000136: (i) Indication of whether the respon- sible party is the sponsor of the clin- ical trial, as that term
p.000136: is defined in 21 CFR 50.3; the sponsor-investigator, as that term is defined in 21 CFR 50.3; or a
p.000136: principal investigator designated pursuant to this part; and
p.000136: (ii) Either:
p.000136: (A) The official name of the entity, if the responsible party is an entity; or
p.000136: (B) The official title and primary or- ganizational affiliation of the indi- vidual, if the responsible
p.000136: party is an in- dividual.
p.000136: (31) Facility Information means, for each participating facility in a clinical trial, the following
p.000136: information:
p.000137: 137
p.000137:
p.000137:
p.000137:
p.000137:
p.000137:
p.000137:
...
p.000141: physical address, mailing address, phone number, and email address of the individual who is the responsible
p.000141: party or of a designated employee of the or- ganization that is the responsible party.
p.000141: (c) Expanded access record. If ex- panded access is available, as specified in 21 CFR 312.315
p.000141: (for an intermediate- size patient population) or 21 CFR
p.000141: 312.320 (under a treatment IND or treatment protocol), for an investiga- tional drug product
p.000141: (including a bio- logical product) studied in an applica- ble drug clinical trial, and the data ele- ments set
p.000141: forth in paragraphs (c)(1) through (4) of this section have not been submitted in an expanded
p.000141: access record for that investigational product, the responsible party, if both the man- ufacturer of the
p.000141: investigational prod- uct and the sponsor of the applicable clinical trial, must submit the clinical trial
p.000141: information specified in para- graphs (c)(1) through (4) of this section to ClinicalTrials.gov in the form
p.000141: of an expanded access record. If expanded ac- cess is available only as specified in 21 CFR 312.310 (for
p.000141: individual patients, in- cluding for emergency use) for an in- vestigational drug product (including a biological
p.000141: product) studied in an appli- cable drug clinical trial, and the data elements set forth in
p.000141: paragraphs (c)(1)(i), (iii), (iv), (vi), (ix), (x), (c)(2)(iv), (c)(3), (c)(4)(i), (iii),(iv),
p.000141: and
p.000141: (v) of this section have not been sub-
p.000141: mitted in an expanded access record for
p.000142: 142
p.000142:
p.000142:
p.000142:
p.000142:
p.000142:
p.000142:
p.000142:
p.000142: Public Health Service, HHS § 11.28
p.000142:
p.000142:
p.000142: that investigational product, the re- sponsible party, if both the manufac- turer of the
p.000142: investigational product and the sponsor of the applicable clin- ical trial, must submit the clinical
p.000142: trial information specified in those paragraphs to ClinicalTrials.gov in the form of an expanded access
p.000142: record.
p.000142: (1) Descriptive information:
p.000142: (i) Brief Title. A short title identi- fying the expanded access, written in language intended for the
p.000142: lay public. If an acronym or abbreviation is used publicly to identify the expanded ac- cess, it must be
p.000142: provided.
...
General/Other / Relationship to Authority
Searching for indicator authority:
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p.000130: 11.42 For which applicable clinical trials must clinical trial results information be submitted?
p.000130: 11.44 When must clinical trial results infor- mation be submitted for applicable clin- ical trials subject
p.000130: to § 11.42?
p.000130: 11.48 What constitutes clinical trial results information?
p.000130: 11.52 By when will the NIH Director post submitted clinical trial results informa- tion?
p.000130: 11.54 What are the procedures for requesting a waiver of the requirements for clinical trial results
p.000130: information submission?
p.000130:
p.000130: Subpart D—Additional Submission of Clinical Trial Information
p.000130: 11.60 What requirements apply to the vol- untary submission of clinical trial infor- mation for clinical
p.000130: trials of FDA-regu- lated drug products (including biological products) and device products?
p.000130: 11.62 What requirements apply to applicable clinical trials for which submission of clinical trial
p.000130: information has been deter- mined by the Director to be necessary to protect the public health?
p.000130: 130
p.000130:
p.000130:
p.000130:
p.000130:
p.000130:
p.000130:
p.000130:
p.000130: Public Health Service, HHS § 11.4
p.000130:
p.000130:
p.000130: 11.64 When must clinical trial information submitted to ClinicalTrials.gov be updated or corrected?
p.000130: Subpart E—Potential Legal Consequences of Non-Compliance
p.000130: 11.66 What are potential legal consequences of not complying with the requirements of this part?
p.000130: AUTHORITY: 42 U.S.C. 282(i); 42 U.S.C. 282(j);
p.000130: 5 U.S.C. 301; 42 U.S.C. 286(a); 42 U.S.C. 241(a);
p.000130: 42 U.S.C. 216(b).
p.000130: SOURCE: 81 FR 65138, Sept. 21, 2016, unless
p.000130: otherwise noted.
p.000130: EFFECTIVE DATE NOTE: At 81 FR 65138,
p.000130: Sept. 21, 2016, Part 11 was added, effective
p.000130: Jan. 18, 2017.
p.000130:
p.000130: Subpart A—General Provisions
p.000130: § 11.2 What is the purpose of this part?
p.000130: This part implements section 402(j) of the Public Health Service Act (42
p.000130: U.S.C. 282(j)) by providing require- ments and procedures for the submis- sion of clinical trial
p.000130: information for certain applicable clinical trials and other clinical trials to the Director of the
p.000130: National Institutes of Health (NIH) to be made publicly available via ClinicalTrials.gov, the
p.000130: Internet-acces- sible clinical trial registry and results data bank established by the National Library of
p.000130: Medicine (NLM) at https:// clinicaltrials.gov.
p.000130: § 11.4 To whom does this part apply?
p.000130: (a) This part applies to the respon- sible party for an applicable clinical trial that is required to
p.000130: be registered under § 11.22, a clinical trial for which clinical trial registration information or clinical
p.000130: trial results information is submitted voluntarily in accordance with § 11.60, or an applicable
p.000130: clinical trial that is required by the Director to have clinical trial information sub- mitted to protect
p.000130: the public health under § 11.62.
...
p.000130: clinical trial will be considered the responsible party unless and until a principal investigator has been
p.000130: des- ignated the responsible party, in ac- cordance with paragraph (c)(2) of this section. With
p.000130: respect to a pediatric postmarket surveillance of a device product that is not a clinical trial, the
p.000130: responsible party is the entity that the
p.000130: U.S. Food and Drug Adminstration (FDA), under section 522 of the Federal Food, Drug, and Cosmetic
p.000130: Act (21
p.000130: U.S.C. 3601), orders to conduct the pedi- atric postmarket surveillance of a de- vice product.
p.000130: (1) Determination of sponsor. For pur- poses of this part, each applicable clin- ical trial or other clinical
p.000130: trial must have one sponsor.
p.000130: (i) When an applicable clinical trial or other clinical trial is conducted under an investigational
p.000130: new drug ap- plication (IND) or investigational de- vice exemption (IDE), the IND or IDE holder will be
p.000130: considered the sponsor.
p.000130: (ii) When an applicable clinical trial or other clinical trial is not conducted under an IND or IDE, the
p.000130: single person or entity who initiates the trial, by preparing and/or planning the trial, and who
p.000130: has authority and control over the trial, will be considered the spon- sor.
p.000130: (2) Designation of a principal investi- gator as the responsible party.
p.000130: (i) The sponsor may designate a prin- cipal investigator as the responsible party if such principal
p.000130: investigator meets all of the following require- ments:
p.000130: (A) Is responsible for conducting the trial;
p.000130: (B) Has access to and control over the data from the trial;
p.000130: (C) Has the right to publish the re- sults of the trial; and
p.000130: (D) Has the ability to meet all of the requirements for submitting and up- dating clinical trial
p.000130: information as specified in this part.
p.000131: 131
p.000131:
p.000131:
p.000131:
p.000131:
p.000131:
p.000131:
p.000131:
p.000131:
p.000131: § 11.6
p.000131: (ii) With regard to an applicable clin- ical trial or other clinical trial, a des- ignation by the sponsor
p.000131: under para- graph (c)(2)(i) of this section shall con- sist of the sponsor obtaining from the principal
p.000131: investigator an acknowledg- ment of the principal investigator’s re- sponsibilities under this part as respon- sible
p.000131: party, and the principal investi- gator acknowledging the designation as responsible party to the
p.000131: Director in the format specified at https:// prsinfo.clinicaltrials.gov.
p.000131: (3) Withdra al of the designation of a principal investigator as the responsible party.
...
p.000133: contractor, or awardee, so long as the principal investigator is re- sponsible for conducting the trial, has
p.000133: access to and control over the data from the clinical trial, has the right to publish the results of the
p.000133: trial, and has the ability to meet all of the require- ments under this part for the submis- sion of
p.000133: clinical trial information. For a pediatric postmarket surveillance of a device product that is not a
p.000133: clinical
p.000134: 134
p.000134:
p.000134:
p.000134:
p.000134:
p.000134:
p.000134:
p.000134:
p.000134: Public Health Service, HHS § 11.10
p.000134:
p.000134:
p.000134: trial, the responsible party is the enti- ty who FDA orders to conduct the pedi- atric postmarket
p.000134: surveillance of the device product.
p.000134: Secondary outcome measure means an outcome measure that is of lesser im- portance than a primary
p.000134: outcome measure, but is part of a pre-specified analysis plan for evaluating the effects of the intervention
p.000134: or interventions under investigation in a clinical trial and is not specified as an exploratory or other
p.000134: measure. A clinical trial may have more than one secondary outcome measure. For purposes of this part,
p.000134: ‘‘secondary outcome’’ has the same meaning as secondary outcome meas- ure.
p.000134: Secretary means the Secretary of
p.000134: Health and Human Services or any other official(s) to whom the Secretary delegates the authority
p.000134: contained in section 402(j) of the Public Health Service Act (42 U.S.C. 282(j)).
p.000134: Serious adverse event means an ad- verse event that results in any of the following outcomes:
p.000134: Death, a life- threatening adverse event as defined in 21 CFR 312.32, inpatient hospitalization or prolongation
p.000134: of existing hospitaliza- tion, a persistent or significant inca- pacity or substantial disruption of the
p.000134: ability to conduct normal life func- tions, or a congenital anomaly/birth defect. Important medical
p.000134: events that may not result in death, be life-threat- ening, or require hospitalization may be considered serious
p.000134: when, based upon appropriate medical judgment, they may jeopardize the human subject and may require
p.000134: medical or surgical inter- vention to prevent one of the outcomes listed in this definition. Examples of such
p.000134: medical events include allergic bronchospasm requiring intensive treatment in an emergency room
p.000134: or at home, blood dyscrasias or convulsions that do not result in inpatient hos- pitalization, or
p.000134: the development of a substance use disorder.
p.000134: Sponsor means either a ‘‘sponsor’’ or
p.000134: ‘‘sponsor-investigator,’’ as each is de- fined in 21 CFR 50.3.
p.000134: Study completion date means, for a clinical trial, the date the final subject was examined or received an
p.000134: interven- tion for purposes of final collection of data for the primary and secondary outcome
...
Orphaned Trigger Words
p.000149: (C) Collection Approach. The type of approach taken to collect adverse event information, whether
p.000149: systematic or non-systematic.
p.000149: (ii) Information for completing three tables summarizing anticipated and unanticipated adverse events
p.000149: collected during an applicable clinical trial:
p.000149: (A) Table of all serious adverse events grouped by organ system, with the number and
p.000149: frequency of each event by arm or comparison group;
p.000149: (B) Table of all adverse events, other than serious adverse events, that ex- ceed a frequency of 5 percent
p.000149: within any arm of the clinical trial, grouped
p.000149: 42 CFR Ch. I (10–1–16 Edition)
p.000149: by organ system, with the number and frequency of each event by arm or com- parison group; and
p.000149: (C) Table of all-cause mortality, with the number and frequency of deaths due to any cause by arm or
p.000149: comparison group.
p.000149: (iii) Information for each table speci- fied in paragraph (a)(4)(ii) of this sec- tion must include the
p.000149: following ele- ments, unless otherwise specified:
p.000149: (A) Adverse Event Arm/Group Informa- tion. A brief description of each arm or comparison group used for
p.000149: submitting adverse event information from the clinical trial, including a descriptive title used to
p.000149: identify each arm or com- parison group.
p.000149: (B) Total Number Affected. The overall number of human subjects affected, by arm or comparison group, by:
p.000149: (1) Serious adverse event(s);
p.000149: (2) Adverse event(s) other than seri- ous adverse events that exceed a fre- quency of 5 percent within
p.000149: any arm of the clinical trial; and
p.000149: (3) Deaths due to any cause.
p.000149: (C) Total Number at Risk. The overall number of human subjects included in the assessment, by arm or
p.000149: comparison group, for:
p.000149: (1) Serious adverse events;
p.000149: (2) Adverse event(s) other than seri- ous adverse events that exceed a fre- quency of 5 percent within
p.000149: any arm of the clinical trial; or
p.000149: (3) Deaths due to any cause.
p.000149: (D) Adverse Event Information. For the two tables described in paragraphs (a)(4)(ii)(A) and (B) of this
p.000149: section, a description of each type of serious ad- verse event and other adverse event that is not a
p.000149: serious adverse event and exceeds a frequency of 5 percent within any arm of the clinical trial, consisting of the
p.000149: following attributes:
p.000149: (1) Descriptive term for the adverse event; and
p.000149: (2) Organ system associated with the adverse event.
p.000149: (E) Adverse Event Data. For the two tables described in paragraphs (a)(4)(ii)(A) and (B) of
p.000149: this section and for each adverse event listed in accord- ance with paragraph (a)(4)(iii)(D) of this section:
p.000149: (1) Number of human subjects af- fected by such adverse event.
p.000150: 150
p.000150:
p.000150:
p.000150:
p.000150:
p.000150:
p.000150:
p.000150:
p.000150: Public Health Service, HHS § 11.48
p.000150:
p.000150:
p.000150: (2) Number of human subjects at risk for such adverse event.
p.000150: (5) Protocol and statistical analysis plan. A copy of the protocol and the statistical analysis
p.000150: plan (if not in- cluded in the protocol), including all amendments that have been approved by a human
...
Appendix
Indicator List
| Indicator | Vulnerability |
|---|
| access | Access to Social Goods |
| age | Age |
| another country | Other Country |
| authority | Relationship to Authority |
| criminal | criminal |
| drug | Drug Usage |
| emergency | Public Emergency |
| ethnicity | Ethnicity |
| gender | gender |
| healthyXvolunteers | Healthy People |
| home | Property Ownership |
| language | Linguistic Proficiency |
| nation | stateless persons |
| orphan | orphan |
| party | political affiliation |
| race | Racial Minority |
| single | Marital Status |
| substance use | substance use |
| threat | Threat of Stigma |
| volunteers | Healthy People |
Indicator Peers (Indicators in Same Vulnerability)
| Indicator | Peers |
|---|
| healthyXvolunteers | ['volunteers'] |
| volunteers | ['healthyXvolunteers'] |
Trigger Words
consent
ethics
protect
protection
risk
Applicable Type / Vulnerability / Indicator Overlay for this Input