Examining the file media/Synopses/8F4B345EA891521BD9110FF0BDAF9518.html:

This file was generated: 2020-01-25 18:19:56

Overall Tag Match Counts:

TagMatch Count
access17
age1
authority37
coerce1
coercion1
drug17
education2
emergency5
ethnic1
fetus1
gender1
health1
homeless1
illness1
impaired1
infant1
influence2
language2
minor1
minors2
minority1
risk20
sex1
special5
substance1
undue influence1
vulnerable3


Searching for tag access:

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    p.000037: 5.14. Supplying and handling investigational product(s) 38
    p.000037: Guideline for good clinical practice E6(R2)
    p.000037: EMA/CHMP/ICH/135/1995
    p.000037: Page 3/68
    p.000037:
    p.000037: 5.15. Record access
    p.000039: 39
    p.000040: 5.16. Safety information
    p.000040: 39
    p.000040: 5.17. Adverse drug reaction reporting 39
    p.000040: 5.18. Monitoring
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    p.000050: 49
    p.000050: 6.8. Assessment of Safety
    p.000050: 49
    p.000050: 6.9. Statistics
    p.000050: 50
    p.000051: 6.10. Direct access to source data/documents 50
    p.000051: 6.11. Quality control and quality assurance 50
    p.000051: 6.12. Ethics
    p.000051: 50
    p.000051: 6.13. Data handling and record keeping 51
    p.000051: 6.14. Financing and insurance 51
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    p.000060: 1.20. Contract Research Organization (CRO)
    p.000060:
    p.000060: A person or an organization (commercial, academic, or other) contracted by the sponsor to perform one or more of a
    p.000060: sponsor's trial-related duties and functions.
    p.000060:
    p.000060: 1.21. Direct access
    p.000060:
    p.000060: Permission to examine, analyze, verify, and reproduce any records and reports that are important to evaluation of a
    p.000060: clinical trial. Any party (e.g., domestic and foreign regulatory authorities, sponsor's monitors and auditors) with
    p.000060: direct access should take all reasonable precautions within the constraints of the applicable regulatory requirement(s)
    p.000060: to maintain the confidentiality of subjects' identities and
    p.000060: sponsor’s proprietary information.
    p.000060:
    p.000060: 1.22. Documentation
    p.000060:
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    p.000060:
    p.000060: l) The anticipated expenses, if any, to the subject for participating in the trial.
    p.000060:
    p.000060: m) That the subject's participation in the trial is voluntary and that the subject may refuse to participate or
    p.000060: withdraw from the trial, at any time, without penalty or loss of benefits to which the subject is otherwise entitled.
    p.000060: n) That the monitor(s), the auditor(s), the IRB/IEC, and the regulatory authority(ies) will be granted direct access
    p.000060: to the subject's original medical records for verification of clinical trial procedures and/or data, without violating
    p.000060: the confidentiality of the subject, to the extent permitted by the applicable laws and regulations and that, by signing
    p.000060: a written informed consent form, the subject or the subject's legally acceptable representative is authorizing such
    p.000060: access.
    p.000060: o) That records identifying the subject will be kept confidential and, to the extent permitted by the applicable laws
    p.000060: and/or regulations, will not be made publicly available. If the results of the trial are published, the subject’s
    p.000060: identity will remain confidential.
    p.000060: p) That the subject or the subject's legally acceptable representative will be informed in a timely manner if
    p.000060: information becomes available that may be relevant to the subject's willingness to continue participation in the trial.
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    p.000060: investigator/institution.
    p.000060:
    p.000060: 4.9.7.
    p.000060:
    p.000060: Upon request of the monitor, auditor, IRB/IEC, or regulatory authority, the investigator/institution should make
    p.000060: available for direct access all requested trial-related records.
    p.000060:
    p.000060:
    p.000060:
    p.000060:
    p.000060:
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    p.000060: EMA/CHMP/ICH/135/1995
    p.000060: Page 31/68
    p.000060:
    p.000060: 5.1.2.
    p.000060:
    p.000060: The sponsor is responsible for securing agreement from all involved parties to ensure direct access (see 1.21) to all
    p.000060: trial related sites, source data/documents , and reports for the purpose of monitoring and auditing by the sponsor, and
    p.000060: inspection by domestic and foreign regulatory authorities.
    p.000060:
    p.000060: 5.1.3.
    p.000060:
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    p.000060: EMA/CHMP/ICH/135/1995
    p.000060: Page 33/68
    p.000060:
    p.000060: c) Ensure that the systems are designed to permit data changes in such a way that the data changes are documented and
    p.000060: that there is no deletion of entered data (i.e. maintain an audit trail, data trail, edit trail).
    p.000060: d) Maintain a security system that prevents unauthorized access to the data.
    p.000060:
    p.000060: e) Maintain a list of the individuals who are authorized to make data changes (see 4.1.5 and 4.9.3).
    p.000060:
    p.000060: f) Maintain adequate backup of the data.
    p.000060:
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    p.000060: b) Maintain sufficient quantities of the investigational product(s) used in the trials to reconfirm specifications,
    p.000060: should this become necessary, and maintain records of batch sample analyses and characteristics. To the extent
    p.000060: stability permits, samples should be retained either until the analyses of the trial data are complete or as required
    p.000060: by the applicable regulatory requirement(s), whichever represents the longer retention period.
    p.000060:
    p.000060: 5.15. Record access
    p.000060:
    p.000060: 5.15.1.
    p.000060:
    p.000060: The sponsor should ensure that it is specified in the protocol or other written agreement that the
    p.000060: investigator(s)/institution(s) provide direct access to source data/documents for trial-related monitoring, audits,
    p.000060: IRB/IEC review, and regulatory inspection.
    p.000060:
    p.000060: 5.15.2.
    p.000060:
    p.000060: The sponsor should verify that each subject has consented, in writing, to direct access to his/her original medical
    p.000060: records for trial-related monitoring, audit, IRB/IEC review, and regulatory inspection.
    p.000060:
    p.000060: 5.16. Safety information
    p.000060:
    p.000060: 5.16.1.
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    p.000060: submissions to regulatory authorities, the number of subjects in the trial, the type and complexity of the trial, the
    p.000060: level of risks to the trial subjects, and any identified problem(s).
    p.000060: c) The observations and findings of the auditor(s) should be documented.
    p.000060:
    p.000060: d) To preserve the independence and value of the audit function, the regulatory authority(ies) should not routinely
    p.000060: request the audit reports. Regulatory authority(ies) may seek access to an audit report on a case by case basis when
    p.000060: evidence of serious GCP non-compliance exists, or in the course of legal proceedings.
    p.000060: e) When required by applicable law or regulation, the sponsor should provide an audit certificate.
    p.000060:
    p.000060: 5.20. Noncompliance
    p.000060:
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    p.000060: 6.9.7.
    p.000060:
    p.000060: The selection of subjects to be included in the analyses (e.g. all randomized subjects, all dosed subjects, all
    p.000060: eligible subjects, evaluable subjects).
    p.000060:
    p.000060: 6.10. Direct access to source data/documents
    p.000060:
    p.000060: The sponsor should ensure that it is specified in the protocol or other written agreement that the
    p.000060: investigator(s)/institution(s) will permit trial-related monitoring, audits, IRB/IEC review, and regulatory
    p.000060: inspection(s), providing direct access to source data/documents.
    p.000060:
    p.000060: 6.11. Quality control and quality assurance
    p.000060:
    p.000060: 6.12. Ethics
    p.000060:
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    p.000060: EMA/CHMP/ICH/135/1995
    p.000060:
    p.000060: Page 59/68
    p.000060:
    p.000060:
    p.000060: The sponsor should ensure that the investigator has control of and continuous access to the CRF data reported to the
    p.000060: sponsor. The sponsor should not have exclusive control of those data.
    p.000060: When a copy is used to replace an original document (e.g., source documents, CRF), the copy should fulfill the
    p.000060: requirements for certified copies.
    p.000060:
    p.000060: The investigator/institution should have control of all essential documents and records generated by the
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    p.000060: conduct, adverse event (AE) reporting
    p.000060:
    p.000060:
    p.000060: To document that consent is obtained in accordance with X GCP and protocol and dated prior to
    p.000060: participation of each
    p.000060: subject in trial. Also to document direct access permission (see 8.2.3)
    p.000060:
    p.000060:
    p.000060: 8.3.13
    p.000060:
    p.000060:
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Searching for tag age:

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    p.000060: including the following, if available:
    p.000060: • Pharmacokinetics (including metabolism, as appropriate, and absorption, plasma protein binding, distribution,
    p.000060: and elimination).
    p.000060: • Bioavailability of the investigational product (absolute, where possible, and/or relative) using a reference
    p.000060: dosage form.
    p.000060: • Population subgroups (e.g., gender, age, and impaired organ function).
    p.000060:
    p.000060: • Interactions (e.g., product-product interactions and effects of food).
    p.000060:
    p.000060: • Other pharmacokinetic data (e.g., results of population studies performed within clinical trial(s).
    p.000060:
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Searching for tag authority:

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    p.000036: 5.7. Allocation of responsibilities
    p.000036: 36
    p.000037: 5.8. Compensation to subjects and investigators 36
    p.000037: 5.9. Financing
    p.000037: 36
    p.000037: 5.10. Notification/submission to regulatory authority(ies) 36
    p.000037: 5.11. Confirmation of review by IRB/IEC 36
    p.000037: 5.12. Information on investigational product(s) 37
    p.000037: 5.13. Manufacturing, packaging, labelling, and coding investigational product(s) 37
    p.000037: 5.14. Supplying and handling investigational product(s) 38
    p.000037: Guideline for good clinical practice E6(R2)
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    p.000060: having been informed of all aspects of the trial that are relevant to the subject's decision to participate. Informed
    p.000060: consent is documented by means of a written, signed and dated informed consent form.
    p.000060:
    p.000060: 1.29. Inspection
    p.000060:
    p.000060: The act by a regulatory authority(ies) of conducting an official review of documents, facilities, records, and any
    p.000060: other resources that are deemed by the authority(ies) to be related to the clinical trial and that may be located at
    p.000060: the site of the trial, at the sponsor's and/or contract research organization’s (CRO’s) facilities, or at other
    p.000060: establishments deemed appropriate by the regulatory authority(ies).
    p.000060:
    p.000060: 1.30. Institution (medical)
    p.000060:
    p.000060: Any public or private entity or agency or medical or dental facility where clinical trials are conducted.
    p.000060:
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    p.000060:
    p.000060: The IRB/IEC should establish, document in writing, and follow its procedures, which should include:
    p.000060:
    p.000060: 3.3.1.
    p.000060:
    p.000060: Determining its composition (names and qualifications of the members) and the authority under which it is established.
    p.000060:
    p.000060:
    p.000060: Guideline for good clinical practice E6(R2)
    p.000060: EMA/CHMP/ICH/135/1995
    p.000060: Page 18/68
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    p.000060:
    p.000060: 3.4. Records
    p.000060:
    p.000060: The IRB/IEC should retain all relevant records (e.g., written procedures, membership lists, lists of
    p.000060: occupations/affiliations of members, submitted documents, minutes of meetings, and correspondence) for a period of at
    p.000060: least 3 years after completion of the trial and make them available upon request from the regulatory authority(ies).
    p.000060: The IRB/IEC may be asked by investigators, sponsors or regulatory authorities to provide its written procedures and
    p.000060: membership lists.
    p.000060:
    p.000060: 4. Investigator
    p.000060: 4.1. Investigator's Qualifications and Agreements
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    p.000060: 4.1.1.
    p.000060:
    p.000060: The investigator(s) should be qualified by education, training, and experience to assume responsibility for the proper
    p.000060: conduct of the trial, should meet all the qualifications specified by the applicable regulatory requirement(s), and
    p.000060: should provide evidence of such qualifications through up-to-date curriculum vitae and/or other relevant documentation
    p.000060: requested by the sponsor, the IRB/IEC, and/or the regulatory authority(ies).
    p.000060:
    p.000060: 4.1.2.
    p.000060:
    p.000060: The investigator should be thoroughly familiar with the appropriate use of the investigational product(s), as described
    p.000060: in the protocol, in the current Investigator's Brochure, in the product information and in other information sources
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    p.000060: The investigator should be aware of, and should comply with, GCP and the applicable regulatory requirements.
    p.000060:
    p.000060: 4.1.4.
    p.000060:
    p.000060: The investigator/institution should permit monitoring and auditing by the sponsor, and inspection by the appropriate
    p.000060: regulatory authority(ies).
    p.000060:
    p.000060: 4.1.5.
    p.000060:
    p.000060: The investigator should maintain a list of appropriately qualified persons to whom the investigator has delegated
    p.000060: significant trial-related duties.
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    p.000060: 4.5. Compliance with Protocol
    p.000060:
    p.000060: 4.5.1.
    p.000060:
    p.000060: The investigator/institution should conduct the trial in compliance with the protocol agreed to by the sponsor and, if
    p.000060: required, by the regulatory authority(ies) and which was given approval/favourable opinion by the IRB/IEC. The
    p.000060: investigator/institution and the sponsor should sign the protocol, or an alternative contract, to confirm agreement.
    p.000060:
    p.000060: 4.5.2.
    p.000060:
    p.000060: The investigator should not implement any deviation from, or changes of the protocol without agreement by the sponsor
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    p.000060: change, the reasons for it, and, if appropriate, the proposed protocol amendment(s) should be submitted:
    p.000060: a) to the IRB/IEC for review and approval/favourable opinion,
    p.000060:
    p.000060: b) to the sponsor for agreement and, if required,
    p.000060:
    p.000060: c) to the regulatory authority(ies).
    p.000060:
    p.000060: 4.6. Investigational Product(s)
    p.000060:
    p.000060: 4.6.1.
    p.000060:
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    p.000060:
    p.000060: l) The anticipated expenses, if any, to the subject for participating in the trial.
    p.000060:
    p.000060: m) That the subject's participation in the trial is voluntary and that the subject may refuse to participate or
    p.000060: withdraw from the trial, at any time, without penalty or loss of benefits to which the subject is otherwise entitled.
    p.000060: n) That the monitor(s), the auditor(s), the IRB/IEC, and the regulatory authority(ies) will be granted direct access
    p.000060: to the subject's original medical records for verification of clinical trial procedures and/or data, without violating
    p.000060: the confidentiality of the subject, to the extent permitted by the applicable laws and regulations and that, by signing
    p.000060: a written informed consent form, the subject or the subject's legally acceptable representative is authorizing such
    p.000060: access.
    p.000060: o) That records identifying the subject will be kept confidential and, to the extent permitted by the applicable laws
...


...
    p.000060: The financial aspects of the trial should be documented in an agreement between the sponsor and the
    p.000060: investigator/institution.
    p.000060:
    p.000060: 4.9.7.
    p.000060:
    p.000060: Upon request of the monitor, auditor, IRB/IEC, or regulatory authority, the investigator/institution should make
    p.000060: available for direct access all requested trial-related records.
    p.000060:
    p.000060:
    p.000060:
    p.000060:
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    p.000060: All serious adverse events (SAEs) should be reported immediately to the sponsor except for those SAEs that the protocol
    p.000060: or other document (e.g., Investigator's Brochure) identifies as not needing immediate reporting. The immediate reports
    p.000060: should be followed promptly by detailed, written reports. The immediate and follow-up reports should identify subjects
    p.000060: by unique code numbers assigned to the trial subjects rather than by the subjects' names, personal identification
    p.000060: numbers, and/or addresses. The investigator should also comply with the applicable regulatory requirement(s) related to
    p.000060: the reporting of unexpected serious adverse drug reactions to the regulatory authority(ies) and the IRB/IEC.
    p.000060:
    p.000060: 4.11.2.
    p.000060:
    p.000060: Adverse events and/or laboratory abnormalities identified in the protocol as critical to safety evaluations should be
    p.000060: reported to the sponsor according to the reporting requirements and within the time periods specified by the sponsor in
...


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    p.000060:
    p.000060: 4.12. Premature Termination or Suspension of a Trial
    p.000060:
    p.000060: If the trial is prematurely terminated or suspended for any reason, the investigator/institution should promptly inform
    p.000060: the trial subjects, should assure appropriate therapy and follow-up for the subjects, and, where required by the
    p.000060: applicable regulatory requirement(s), should inform the regulatory authority(ies). In addition:
    p.000060:
    p.000060: 4.12.1.
    p.000060:
    p.000060: If the investigator terminates or suspends a trial without prior agreement of the sponsor, the investigator should
    p.000060: inform the institution where applicable, and the investigator/institution should promptly inform the sponsor and the
...


...
    p.000060:
    p.000060: 4.13. Final Report(s) by Investigator
    p.000060:
    p.000060: Upon completion of the trial, the investigator, where applicable, should inform the institution; the
    p.000060: investigator/institution should provide the IRB/IEC with a summary of the trial’s outcome, and the regulatory
    p.000060: authority(ies) with any reports required.
    p.000060:
    p.000060: 5. Sponsor
    p.000060:
    p.000060: ADDENDUM
    p.000060:
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    p.000060: EMA/CHMP/ICH/135/1995
    p.000060: Page 34/68
    p.000060:
    p.000060: 5.5.10.
    p.000060:
    p.000060: Any transfer of ownership of the data should be reported to the appropriate authority(ies), as required by the
    p.000060: applicable regulatory requirement(s).
    p.000060:
    p.000060: 5.5.11.
    p.000060:
    p.000060: The sponsor specific essential documents should be retained until at least 2 years after the last approval of a
...


...
    p.000060: 5.9. Financing
    p.000060:
    p.000060: The financial aspects of the trial should be documented in an agreement between the sponsor and the
    p.000060: investigator/institution.
    p.000060:
    p.000060: 5.10. Notification/submission to regulatory authority(ies)
    p.000060:
    p.000060: Before initiating the clinical trial(s), the sponsor (or the sponsor and the investigator, if required by the
    p.000060: applicable regulatory requirement(s)) should submit any required application(s) to the appropriate authority(ies) for
    p.000060: review, acceptance, and/or permission (as required by the applicable regulatory requirement(s)) to begin the trial(s).
    p.000060: Any notification/submission should be dated and contain sufficient information to identify the protocol.
    p.000060:
    p.000060: 5.11. Confirmation of review by IRB/IEC
    p.000060:
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    p.000060: The sponsor is responsible for supplying the investigator(s)/institution(s) with the investigational product(s).
    p.000060:
    p.000060: 5.14.2.
    p.000060:
    p.000060: The sponsor should not supply an investigator/institution with the investigational product(s) until the sponsor obtains
    p.000060: all required documentation (e.g. approval/favourable opinion from IRB/IEC and regulatory authority(ies)).
    p.000060:
    p.000060: 5.14.3.
    p.000060:
    p.000060: The sponsor should ensure that written procedures include instructions that the investigator/institution should follow
    p.000060: for the handling and storage of investigational product(s) for the trial and documentation thereof. The procedures
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...
    p.000060:
    p.000060: The sponsor is responsible for the ongoing safety evaluation of the investigational product(s).
    p.000060:
    p.000060: 5.16.2.
    p.000060:
    p.000060: The sponsor should promptly notify all concerned investigator(s)/institution(s) and the regulatory authority(ies) of
    p.000060: findings that could affect adversely the safety of subjects, impact the conduct of the trial, or alter the IRB/IEC's
    p.000060: approval/favourable opinion to continue the trial.
    p.000060:
    p.000060: 5.17. Adverse drug reaction reporting
    p.000060:
    p.000060: 5.17.1.
    p.000060:
    p.000060: The sponsor should expedite the reporting to all concerned investigator(s)/institutions(s), to the IRB(s)/IEC(s), where
    p.000060: required, and to the regulatory authority(ies) of all adverse drug reactions (ADRs) that are both serious and
    p.000060: unexpected.
    p.000060:
    p.000060:
    p.000060:
    p.000060:
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    p.000060: Such expedited reports should comply with the applicable regulatory requirement(s) and with the ICH Guideline for
    p.000060: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting.
    p.000060:
    p.000060: 5.17.3.
    p.000060:
    p.000060: The sponsor should submit to the regulatory authority(ies) all safety updates and periodic reports, as required by
    p.000060: applicable regulatory requirement(s).
    p.000060:
    p.000060: 5.18. Monitoring
    p.000060:
    p.000060: 5.18.1. Purpose
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    p.000060: b) The sponsor's audit plan and procedures for a trial audit should be guided by the importance of the trial to
    p.000060: submissions to regulatory authorities, the number of subjects in the trial, the type and complexity of the trial, the
    p.000060: level of risks to the trial subjects, and any identified problem(s).
    p.000060: c) The observations and findings of the auditor(s) should be documented.
    p.000060:
    p.000060: d) To preserve the independence and value of the audit function, the regulatory authority(ies) should not routinely
    p.000060: request the audit reports. Regulatory authority(ies) may seek access to an audit report on a case by case basis when
    p.000060: evidence of serious GCP non-compliance exists, or in the course of legal proceedings.
    p.000060: e) When required by applicable law or regulation, the sponsor should provide an audit certificate.
    p.000060:
    p.000060: 5.20. Noncompliance
    p.000060:
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    p.000060: 5.20.2.
    p.000060:
    p.000060: If the monitoring and/or auditing identifies serious and/or persistent noncompliance on the part of an
    p.000060: investigator/institution, the sponsor should terminate the investigator's/institution’s participation in the trial.
    p.000060: When an investigator's/institution’s participation is terminated because of noncompliance, the sponsor
    p.000060: should notify promptly the regulatory authority(ies).
    p.000060:
    p.000060: 5.21. Premature termination or suspension of a trial
    p.000060:
    p.000060: If a trial is prematurely terminated or suspended, the sponsor should promptly inform the investigators/institutions,
    p.000060: and the regulatory authority(ies) of the termination or suspension and the reason(s) for the termination or suspension.
    p.000060: The IRB/IEC should also be informed promptly and
    p.000060:
    p.000060:
    p.000060: Guideline for good clinical practice E6(R2)
    p.000060: EMA/CHMP/ICH/135/1995
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    p.000060: For multicentre trials, the sponsor should ensure that:
    p.000060:
    p.000060: 5.23.1.
    p.000060:
    p.000060: All investigators conduct the trial in strict compliance with the protocol agreed to by the sponsor and, if required,
    p.000060: by the regulatory authority(ies), and given approval/favourable opinion by the IRB/IEC.
    p.000060:
    p.000060: 5.23.2.
    p.000060:
    p.000060: The CRFs are designed to capture the required data at all multicentre trial sites. For those investigators who are
    p.000060: collecting additional data, supplemental CRFs should also be provided that are designed to capture the additional data.
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    p.000060: and the quality of the data produced. These documents serve to demonstrate the compliance of the investigator, sponsor
    p.000060: and monitor with the standards of Good Clinical Practice and with all applicable regulatory requirements.
    p.000060: Essential Documents also serve a number of other important purposes. Filing essential documents at the
    p.000060: investigator/institution and sponsor sites in a timely manner can greatly assist in the successful management of a
    p.000060: trial by the investigator, sponsor and monitor. These documents are also the ones which are usually audited by the
    p.000060: sponsor's independent audit function and inspected by the regulatory authority(ies) as part of the process to confirm
    p.000060: the validity of the trial conduct and the integrity of data collected.
    p.000060: The minimum list of essential documents which has been developed follows. The various documents are grouped in three
    p.000060: sections according to the stage of the trial during which they will normally be generated: 1) before the clinical phase
    p.000060: of the trial commences, 2) during the clinical conduct of the trial, and 3) after completion or termination of the
    p.000060: trial. A description is given of the purpose of each document, and whether it should be filed in either the
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    p.000060: individual elements are readily identifiable.
    p.000060: Trial master files should be established at the beginning of the trial, both at the investigator/institution’s site and
    p.000060: at the sponsor's office. A final close-out of a trial can only be done when the monitor has reviewed both
    p.000060: investigator/institution and sponsor files and confirmed that all necessary documents are in the appropriate files.
    p.000060: Any or all of the documents addressed in this guideline may be subject to, and should be available for, audit by the
    p.000060: sponsor’s auditor and inspection by the regulatory authority(ies).
    p.000060: ADDENDUM
    p.000060:
    p.000060: The sponsor and investigator/institution should maintain a record of the location(s) of their respective essential
    p.000060: documents including source documents. The storage system used during the trial and for archiving (irrespective of the
    p.000060: type of media used) should provide for document identification, version history, search, and retrieval.
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    p.000060: 8.2.7
    p.000060: SIGNED AGREEMENT BETWEEN INVOLVED PARTIES, e.g.:
    p.000060: - investigator/institution and sponsor
    p.000060: - investigator/institution and CRO
    p.000060: - sponsor and CRO
    p.000060: - investigator/institution and authority(ies) (where required)
    p.000060: DATED, DOCUMENTED APPROVAL/FAVOURABLE OPINION OF INSTITUTIONAL REVIEW BOARD (IRB)
    p.000060: /INDEPENDENT ETHICS COMMITTEE (IEC) OF THE FOLLOWING:
    p.000060: - protocol and any amendments
    p.000060: - CRF (if applicable)
    p.000060: - informed consent form(s)
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    p.000060:
    p.000060:
    p.000060:
    p.000060:
    p.000060: 8.2.10
    p.000060: REGULATORY AUTHORITY(IES) AUTHORISATION/APPROVAL/ NOTIFICATION OF PROTOCOL
    p.000060: (where required)
    p.000060:
    p.000060: CURRICULUM VITAE AND/OR OTHER RELEVANT DOCUMENTS EVIDENCING QUALIFICATIONS OF INVESTIGATOR(S) AND SUB-INVESTIGATOR(S)
    p.000060: To document appropriate authorisation/approval/notification by the regulatory authority(ies) has been obtained prior to
    p.000060: initiation of the trial in compliance with the applicable regulatory requirement(s)
    p.000060: To document qualifications and eligibility to conduct trial and/or provide medical supervision of subjects
    p.000060: X
    p.000060: (where required)
    p.000060:
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    p.000060:
    p.000060:
    p.000060: 8.3.5
    p.000060: Title of Document
    p.000060:
    p.000060: REGULATORY AUTHORITY(IES) AUTHORISATIONS/APPROVALS/NOTIFICAT IONS WHERE REQUIRED FOR:
    p.000060: - protocol amendment(s) and other documents CURRICULUM VITAE FOR NEW INVESTIGATOR(S) AND/OR SUB- INVESTIGATOR(S)
    p.000060: Purpose
    p.000060:
    p.000060: To document compliance with applicable regulatory requirements
    p.000060:
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    p.000060: 8.3.24
    p.000060:
    p.000060: 8.3.25
    p.000060: Title of Document
    p.000060:
    p.000060: NOTIFICATION BY SPONSOR AND/OR INVESTIGATOR, WHERE APPLICABLE, TO REGULATORY AUTHORITY(IES) AND IRB(S)/IEC(S) OF
    p.000060: UNEXPECTED SERIOUS ADVERSE DRUG REACTIONS AND OF OTHER SAFETY INFORMATION
    p.000060: NOTIFICATION BY SPONSOR TO INVESTIGATORS OF SAFETY INFORMATION INTERIM OR ANNUAL REPORTS TO IRB/IEC AND AUTHORITY(IES)
    p.000060:
    p.000060: SUBJECT SCREENING LOG
    p.000060:
    p.000060:
    p.000060: SUBJECT IDENTIFICATION CODE LIST
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    p.000060: Notification by sponsor and/or investigator, where applicable, to regulatory authorities and IRB(s)/IEC(s) of
    p.000060: unexpected serious adverse drug reactions in accordance with 5.17 and 4.11.1 and of other safety information in
    p.000060: accordance with 5.16.2 and 4.11.2
    p.000060:
    p.000060: Notification by sponsor to investigators of safety information in accordance with 5.16.2
    p.000060: Interim or annual reports provided to IRB/IEC in accordance with 4.10 and to authority(ies) in accordance with 5.17.3
    p.000060: To document identification of subjects who entered pre- trial screening
    p.000060:
    p.000060: To document that investigator/institution keeps a confidential list of names of all subjects allocated to trial numbers
    p.000060: on enrolling in the trial. Allows investigator/institution to reveal identity of any subject To document chronological
    p.000060: enrolment of subjects by trial number
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    p.000060:
    p.000060: AUDIT CERTIFICATE (if available)
    p.000060: FINAL TRIAL CLOSE-OUT MONITORING REPORT
    p.000060:
    p.000060: TREATMENT ALLOCATION AND DECODING DOCUMENTATION
    p.000060: FINAL REPORT BY INVESTIGATOR TO IRB/IEC WHERE REQUIRED, AND WHERE APPLICABLE, TO THE REGULATORY AUTHORITY(IES)
    p.000060: CLINICAL STUDY REPORT
    p.000060: Purpose
    p.000060:
    p.000060: To document that the investigational product(s) have been used according to the protocol. To documents the final
    p.000060: accounting of investigational product(s) received at the site, dispensed to subjects, returned by the subjects, and
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    p.000060: informed in a timely manner if new information becomes available that may be relevant to the subject’s willingness to
    p.000060: continue participation in the trial. The communication of this information should be documented.
    p.000060:
    p.000060: 4.8.3.
    p.000060:
    p.000060: Neither the investigator, nor the trial staff, should coerce or unduly influence a subject to participate or to
    p.000060: continue to participate in a trial.
    p.000060:
    p.000060: 4.8.4.
    p.000060:
    p.000060: None of the oral and written information concerning the trial, including the written informed consent form, should
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    p.000060: (i.e. in emergency situations).
    p.000060:
    p.000060: 3.1.8.
    p.000060:
    p.000060: The IRB/IEC should review both the amount and method of payment to subjects to assure that neither presents problems of
    p.000060: coercion or undue influence on the trial subjects. Payments to a subject should be prorated and not wholly contingent
    p.000060: on completion of the trial by the subject.
    p.000060:
    p.000060: 3.1.9.
    p.000060:
    p.000060: The IRB/IEC should ensure that information regarding payment to subjects, including the methods, amounts, and schedule
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    p.000037:
    p.000037: 5.15. Record access
    p.000039: 39
    p.000040: 5.16. Safety information
    p.000040: 39
    p.000040: 5.17. Adverse drug reaction reporting 39
    p.000040: 5.18. Monitoring
    p.000040: 40
    p.000041: 5.18.1. Purpose
    p.000041: 40
    p.000041: 5.18.2. Selection and qualifications of monitors 40
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    p.000060: Guideline for good clinical practice E6(R2)
    p.000060: EMA/CHMP/ICH/135/1995
    p.000060: Page 6/68
    p.000060:
    p.000060: 1. Glossary
    p.000060: 1.1. Adverse Drug Reaction (ADR)
    p.000060:
    p.000060: In the pre-approval clinical experience with a new medicinal product or its new usages, particularly as the therapeutic
    p.000060: dose(s) may not be established: all noxious and unintended responses to a medicinal product related to any dose should
    p.000060: be considered adverse drug reactions. The phrase responses to a medicinal product means that a causal relationship
    p.000060: between a medicinal product and an adverse event is at least a reasonable possibility, i.e. the relationship cannot be
    p.000060: ruled out.
    p.000060: Regarding marketed medicinal products: a response to a drug which is noxious and unintended and which occurs at doses
    p.000060: normally used in man for prophylaxis, diagnosis, or therapy of diseases or for modification of physiological function
    p.000060: (see the ICH Guideline for Clinical Safety Data Management: Definitions and Standards for Expedited Reporting).
    p.000060:
    p.000060: 1.2. Adverse Event (AE)
    p.000060:
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    p.000060:
    p.000060: Bodies having the power to regulate. In the ICH GCP guideline the expression Regulatory Authorities includes the
    p.000060: authorities that review submitted clinical data and those that conduct inspections (see 1.29). These bodies are
    p.000060: sometimes referred to as competent authorities.
    p.000060:
    p.000060: 1.50. Serious Adverse Event (SAE) or Serious Adverse Drug Reaction (Serious ADR)
    p.000060:
    p.000060: Any untoward medical occurrence that at any dose:
    p.000060:
    p.000060: • results in death,
    p.000060:
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    p.000060:
    p.000060: 1.59. Trial site
    p.000060:
    p.000060: The location(s) where trial-related activities are actually conducted.
    p.000060:
    p.000060: 1.60. Unexpected adverse drug reaction
    p.000060:
    p.000060: An adverse reaction, the nature or severity of which is not consistent with the applicable product information (e.g.,
    p.000060: Investigator's Brochure for an unapproved investigational product or package insert/summary of product characteristics
    p.000060: for an approved product) (see the ICH Guideline for Clinical Safety Data Management: Definitions and Standards for
    p.000060: Expedited Reporting).
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    p.000060: Specifying that the investigator should promptly report to the IRB/IEC:
    p.000060:
    p.000060: a) Deviations from, or changes of, the protocol to eliminate immediate hazards to the trial subjects (see 3.3.7,
    p.000060: 4.5.2, 4.5.4).
    p.000060: b) Changes increasing the risk to subjects and/or affecting significantly the conduct of the trial (see 4.10.2).
    p.000060: c) All adverse drug reactions (ADRs) that are both serious and unexpected.
    p.000060:
    p.000060: d) New information that may affect adversely the safety of the subjects or the conduct of the trial.
    p.000060:
    p.000060: 3.3.9.
    p.000060:
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    p.000060: All serious adverse events (SAEs) should be reported immediately to the sponsor except for those SAEs that the protocol
    p.000060: or other document (e.g., Investigator's Brochure) identifies as not needing immediate reporting. The immediate reports
    p.000060: should be followed promptly by detailed, written reports. The immediate and follow-up reports should identify subjects
    p.000060: by unique code numbers assigned to the trial subjects rather than by the subjects' names, personal identification
    p.000060: numbers, and/or addresses. The investigator should also comply with the applicable regulatory requirement(s) related to
    p.000060: the reporting of unexpected serious adverse drug reactions to the regulatory authority(ies) and the IRB/IEC.
    p.000060:
    p.000060: 4.11.2.
    p.000060:
    p.000060: Adverse events and/or laboratory abnormalities identified in the protocol as critical to safety evaluations should be
    p.000060: reported to the sponsor according to the reporting requirements and within the time periods specified by the sponsor in
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    p.000060:
    p.000060: The sponsor should promptly notify all concerned investigator(s)/institution(s) and the regulatory authority(ies) of
    p.000060: findings that could affect adversely the safety of subjects, impact the conduct of the trial, or alter the IRB/IEC's
    p.000060: approval/favourable opinion to continue the trial.
    p.000060:
    p.000060: 5.17. Adverse drug reaction reporting
    p.000060:
    p.000060: 5.17.1.
    p.000060:
    p.000060: The sponsor should expedite the reporting to all concerned investigator(s)/institutions(s), to the IRB(s)/IEC(s), where
    p.000060: required, and to the regulatory authority(ies) of all adverse drug reactions (ADRs) that are both serious and
    p.000060: unexpected.
    p.000060:
    p.000060:
    p.000060:
    p.000060:
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    p.000060:
    p.000060: A summary of information should be provided about the investigational product's/products' (including metabolites, where
    p.000060: appropriate) safety, pharmacodynamics, efficacy, and dose response that were obtained from preceding trials in humans
    p.000060: (healthy volunteers and/or patients). The implications of this information should be discussed. In cases where a number
    p.000060: of clinical trials have been completed, the use of summaries of safety and efficacy across multiple trials by
    p.000060: indications in subgroups may provide a clear presentation of the data. Tabular summaries of adverse drug reactions for
    p.000060: all the clinical trials (including those for all the studied indications) would be useful. Important differences in
    p.000060: adverse drug reaction patterns/incidences across indications or subgroups should be discussed.
    p.000060: The IB should provide a description of the possible risks and adverse drug reactions to be anticipated on the basis of
    p.000060: prior experiences with the product under investigation and with related products. A description should also be provided
    p.000060: of the precautions or special monitoring to be done as part of the investigational use of the product(s).
    p.000060: c) Marketing experience
    p.000060:
    p.000060:
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    p.000060: This section should provide an overall discussion of the nonclinical and clinical data, and should summarise the
    p.000060: information from various sources on different aspects of the investigational product(s), wherever possible. In this
    p.000060: way, the investigator can be provided with the most informative interpretation of the available data and with an
    p.000060: assessment of the implications of the information for future clinical trials.
    p.000060: Where appropriate, the published reports on related products should be discussed. This could help the investigator to
    p.000060: anticipate adverse drug reactions or other problems in clinical trials.
    p.000060: The overall aim of this section is to provide the investigator with a clear understanding of the possible risks and
    p.000060: adverse reactions, and of the specific tests, observations, and precautions that may be needed for a clinical trial.
    p.000060: This understanding should be based on the available physical, chemical, pharmaceutical, pharmacological, toxicological,
    p.000060: and clinical information on the investigational product(s). Guidance should also be provided to the clinical
    p.000060: investigator on the recognition and treatment of possible overdose and adverse drug reactions that is based on previous
    p.000060: human experience and on the pharmacology of the investigational product.
    p.000060:
    p.000060:
    p.000060:
    p.000060:
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    p.000060:
    p.000060: 8.3.25
    p.000060: Title of Document
    p.000060:
    p.000060: NOTIFICATION BY SPONSOR AND/OR INVESTIGATOR, WHERE APPLICABLE, TO REGULATORY AUTHORITY(IES) AND IRB(S)/IEC(S) OF
    p.000060: UNEXPECTED SERIOUS ADVERSE DRUG REACTIONS AND OF OTHER SAFETY INFORMATION
    p.000060: NOTIFICATION BY SPONSOR TO INVESTIGATORS OF SAFETY INFORMATION INTERIM OR ANNUAL REPORTS TO IRB/IEC AND AUTHORITY(IES)
    p.000060:
    p.000060: SUBJECT SCREENING LOG
    p.000060:
    p.000060:
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    p.000060:
    p.000060: RECORD OF RETAINED BODY FLUIDS/ TISSUE SAMPLES (IF ANY)
    p.000060: Purpose
    p.000060:
    p.000060: Notification by sponsor and/or investigator, where applicable, to regulatory authorities and IRB(s)/IEC(s) of
    p.000060: unexpected serious adverse drug reactions in accordance with 5.17 and 4.11.1 and of other safety information in
    p.000060: accordance with 5.16.2 and 4.11.2
    p.000060:
    p.000060: Notification by sponsor to investigators of safety information in accordance with 5.16.2
    p.000060: Interim or annual reports provided to IRB/IEC in accordance with 4.10 and to authority(ies) in accordance with 5.17.3
    p.000060: To document identification of subjects who entered pre- trial screening
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    p.000060: The medical care given to, and medical decisions made on behalf of, subjects should always be the responsibility of a
    p.000060: qualified physician or, when appropriate, of a qualified dentist.
    p.000060:
    p.000060: 2.8.
    p.000060:
    p.000060: Each individual involved in conducting a trial should be qualified by education, training, and experience to perform
    p.000060: his or her respective task(s).
    p.000060:
    p.000060: 2.9.
    p.000060:
    p.000060: Freely given informed consent should be obtained from every subject prior to clinical trial participation.
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    p.000060: 4. Investigator
    p.000060: 4.1. Investigator's Qualifications and Agreements
    p.000060:
    p.000060: 4.1.1.
    p.000060:
    p.000060: The investigator(s) should be qualified by education, training, and experience to assume responsibility for the proper
    p.000060: conduct of the trial, should meet all the qualifications specified by the applicable regulatory requirement(s), and
    p.000060: should provide evidence of such qualifications through up-to-date curriculum vitae and/or other relevant documentation
    p.000060: requested by the sponsor, the IRB/IEC, and/or the regulatory authority(ies).
    p.000060:
    p.000060: 4.1.2.
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    p.000060: Individuals whose willingness to volunteer in a clinical trial may be unduly influenced by the expectation, whether
    p.000060: justified or not, of benefits associated with participation, or of a retaliatory response from senior members of a
    p.000060: hierarchy in case of refusal to participate. Examples are members of a group with a hierarchical structure, such as
    p.000060: medical, pharmacy, dental, and nursing students, subordinate hospital and laboratory personnel, employees of the
    p.000060: pharmaceutical industry, members of the armed forces, and persons kept in detention. Other vulnerable subjects include
    p.000060: patients with incurable diseases, persons in nursing homes, unemployed or impoverished persons, patients in emergency
    p.000060: situations, ethnic minority groups, homeless persons, nomads, refugees, minors, and those incapable of giving consent.
    p.000060:
    p.000060: 1.62. Well-being (of the trial subjects)
    p.000060:
    p.000060: The physical and mental integrity of the subjects participating in a clinical trial.
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    p.000060: 3.1.7.
    p.000060:
    p.000060: Where the protocol indicates that prior consent of the trial subject or the subject’s legally acceptable representative
    p.000060: is not possible (see 4.8.15), the IRB/IEC should determine that the proposed protocol and/or other document(s)
    p.000060: adequately addresses relevant ethical concerns and meets applicable regulatory requirements for such trials
    p.000060: (i.e. in emergency situations).
    p.000060:
    p.000060: 3.1.8.
    p.000060:
    p.000060: The IRB/IEC should review both the amount and method of payment to subjects to assure that neither presents problems of
    p.000060: coercion or undue influence on the trial subjects. Payments to a subject should be prorated and not wholly contingent
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    p.000060: the investigational product is intended. Subjects in these trials should be particularly closely monitored and should
    p.000060: be withdrawn if they appear to be unduly distressed.
    p.000060:
    p.000060: 4.8.15.
    p.000060:
    p.000060: In emergency situations, when prior consent of the subject is not possible, the consent of the subject's legally
    p.000060: acceptable representative, if present, should be requested. When prior consent of the subject is not possible, and the
    p.000060: subject’s legally acceptable representative is not available, enrolment of the subject should require measures
    p.000060: described in the protocol and/or elsewhere, with documented approval/favourable opinion by the IRB/IEC, to protect the
    p.000060: rights, safety and well-being of the subject and to ensure compliance with applicable regulatory requirements. The
    p.000060: subject or the subject's legally acceptable representative should be informed about the trial as soon as possible and
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    p.000060: transport and storage.
    p.000060:
    p.000060: 5.13.4.
    p.000060:
    p.000060: In blinded trials, the coding system for the investigational product(s) should include a mechanism that permits rapid
    p.000060: identification of the product(s) in case of a medical emergency, but does not permit undetectable breaks of the
    p.000060: blinding.
    p.000060:
    p.000060: 5.13.5.
    p.000060:
    p.000060: If significant formulation changes are made in the investigational or comparator product(s) during the course of
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    p.000060:
    p.000060:
    p.000060: PRE-TRIAL MONITORING REPORT
    p.000060:
    p.000060: TRIAL INITIATION MONITORING REPORT
    p.000060: To document how, in case of an emergency, identity of blinded investigational product can be revealed without breaking
    p.000060: the blind for the remaining subjects' treatment To document method for randomisation of trial population
    p.000060:
    p.000060:
    p.000060: To document that the site is suitable for the trial (may be combined with 8.2.20)
    p.000060: To document that trial procedures were reviewed with the investigator and the investigator’s trial staff ( may be
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    p.000060: justified or not, of benefits associated with participation, or of a retaliatory response from senior members of a
    p.000060: hierarchy in case of refusal to participate. Examples are members of a group with a hierarchical structure, such as
    p.000060: medical, pharmacy, dental, and nursing students, subordinate hospital and laboratory personnel, employees of the
    p.000060: pharmaceutical industry, members of the armed forces, and persons kept in detention. Other vulnerable subjects include
    p.000060: patients with incurable diseases, persons in nursing homes, unemployed or impoverished persons, patients in emergency
    p.000060: situations, ethnic minority groups, homeless persons, nomads, refugees, minors, and those incapable of giving consent.
    p.000060:
    p.000060: 1.62. Well-being (of the trial subjects)
    p.000060:
    p.000060: The physical and mental integrity of the subjects participating in a clinical trial.
    p.000060:
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    p.000060:
    p.000060: Guideline for good clinical practice E6(R2)
    p.000060: EMA/CHMP/ICH/135/1995
    p.000060: Page 25/68
    p.000060:
    p.000060: g) The reasonably foreseeable risks or inconveniences to the subject and, when applicable, to an embryo, fetus, or
    p.000060: nursing infant.
    p.000060: h) The reasonably expected benefits. When there is no intended clinical benefit to the subject, the subject should be
    p.000060: made aware of this.
    p.000060: i) The alternative procedure(s) or course(s) of treatment that may be available to the subject, and their important
    p.000060: potential benefits and risks.
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    p.000060: including the following, if available:
    p.000060: • Pharmacokinetics (including metabolism, as appropriate, and absorption, plasma protein binding, distribution,
    p.000060: and elimination).
    p.000060: • Bioavailability of the investigational product (absolute, where possible, and/or relative) using a reference
    p.000060: dosage form.
    p.000060: • Population subgroups (e.g., gender, age, and impaired organ function).
    p.000060:
    p.000060: • Interactions (e.g., product-product interactions and effects of food).
    p.000060:
    p.000060: • Other pharmacokinetic data (e.g., results of population studies performed within clinical trial(s).
    p.000060:
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    p.000060: that have their origin in the Declaration of Helsinki, and that the clinical trial data are credible.
    p.000060: The objective of this ICH GCP Guideline is to provide a unified standard for the European Union (EU), Japan and the
    p.000060: United States to facilitate the mutual acceptance of clinical data by the regulatory authorities in these
    p.000060: jurisdictions.
    p.000060: The guideline was developed with consideration of the current good clinical practices of the European Union, Japan, and
    p.000060: the United States, as well as those of Australia, Canada, the Nordic countries and the World Health Organization (WHO).
    p.000060: This guideline should be followed when generating clinical trial data that are intended to be submitted to regulatory
    p.000060: authorities.
    p.000060: The principles established in this guideline may also be applied to other clinical investigations that may have an
    p.000060: impact on the safety and well-being of human subjects.
    p.000060: ADDENDUM
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    p.000060: justified or not, of benefits associated with participation, or of a retaliatory response from senior members of a
    p.000060: hierarchy in case of refusal to participate. Examples are members of a group with a hierarchical structure, such as
    p.000060: medical, pharmacy, dental, and nursing students, subordinate hospital and laboratory personnel, employees of the
    p.000060: pharmaceutical industry, members of the armed forces, and persons kept in detention. Other vulnerable subjects include
    p.000060: patients with incurable diseases, persons in nursing homes, unemployed or impoverished persons, patients in emergency
    p.000060: situations, ethnic minority groups, homeless persons, nomads, refugees, minors, and those incapable of giving consent.
    p.000060:
    p.000060: 1.62. Well-being (of the trial subjects)
    p.000060:
    p.000060: The physical and mental integrity of the subjects participating in a clinical trial.
    p.000060:
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    p.000060: 4.3.2.
    p.000060:
    p.000060: During and following a subject's participation in a trial, the investigator/institution should ensure that
    p.000060: adequate medical care is provided to a subject for any adverse events, including clinically significant laboratory
    p.000060: values, related to the trial. The investigator/institution should inform a subject when medical care is needed for
    p.000060: intercurrent illness(es) of which the investigator becomes aware.
    p.000060:
    p.000060: 4.3.3.
    p.000060:
    p.000060: It is recommended that the investigator inform the subject's primary physician about the subject's participation in the
    p.000060: trial if the subject has a primary physician and if the subject agrees to the primary physician being informed.
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    p.000060: including the following, if available:
    p.000060: • Pharmacokinetics (including metabolism, as appropriate, and absorption, plasma protein binding, distribution,
    p.000060: and elimination).
    p.000060: • Bioavailability of the investigational product (absolute, where possible, and/or relative) using a reference
    p.000060: dosage form.
    p.000060: • Population subgroups (e.g., gender, age, and impaired organ function).
    p.000060:
    p.000060: • Interactions (e.g., product-product interactions and effects of food).
    p.000060:
    p.000060: • Other pharmacokinetic data (e.g., results of population studies performed within clinical trial(s).
    p.000060:
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    p.000060: Guideline for good clinical practice E6(R2)
    p.000060: EMA/CHMP/ICH/135/1995
    p.000060: Page 25/68
    p.000060:
    p.000060: g) The reasonably foreseeable risks or inconveniences to the subject and, when applicable, to an embryo, fetus, or
    p.000060: nursing infant.
    p.000060: h) The reasonably expected benefits. When there is no intended clinical benefit to the subject, the subject should be
    p.000060: made aware of this.
    p.000060: i) The alternative procedure(s) or course(s) of treatment that may be available to the subject, and their important
    p.000060: potential benefits and risks.
    p.000060: j) The compensation and/or treatment available to the subject in the event of trial-related injury.
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    p.000060: (i.e. in emergency situations).
    p.000060:
    p.000060: 3.1.8.
    p.000060:
    p.000060: The IRB/IEC should review both the amount and method of payment to subjects to assure that neither presents problems of
    p.000060: coercion or undue influence on the trial subjects. Payments to a subject should be prorated and not wholly contingent
    p.000060: on completion of the trial by the subject.
    p.000060:
    p.000060: 3.1.9.
    p.000060:
    p.000060: The IRB/IEC should ensure that information regarding payment to subjects, including the methods, amounts, and schedule
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    p.000060: informed in a timely manner if new information becomes available that may be relevant to the subject’s willingness to
    p.000060: continue participation in the trial. The communication of this information should be documented.
    p.000060:
    p.000060: 4.8.3.
    p.000060:
    p.000060: Neither the investigator, nor the trial staff, should coerce or unduly influence a subject to participate or to
    p.000060: continue to participate in a trial.
    p.000060:
    p.000060: 4.8.4.
    p.000060:
    p.000060: None of the oral and written information concerning the trial, including the written informed consent form, should
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    p.000060: continue to participate in a trial.
    p.000060:
    p.000060: 4.8.4.
    p.000060:
    p.000060: None of the oral and written information concerning the trial, including the written informed consent form, should
    p.000060: contain any language that causes the subject or the subject's legally acceptable representative to waive or to appear
    p.000060: to waive any legal rights, or that releases or appears to release the investigator, the institution, the sponsor, or
    p.000060: their agents from liability for negligence.
    p.000060:
    p.000060: 4.8.5.
    p.000060:
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    p.000060:
    p.000060: pertinent aspects of the trial including the written information and the approval/ favourable opinion by the IRB/IEC.
    p.000060:
    p.000060: 4.8.6.
    p.000060:
    p.000060: The language used in the oral and written information about the trial, including the written informed consent form,
    p.000060: should be as non-technical as practical and should be understandable to the subject or the subject's legally acceptable
    p.000060: representative and the impartial witness, where applicable.
    p.000060:
    p.000060: 4.8.7.
    p.000060:
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    p.000060: Determining the frequency of continuing review, as appropriate.
    p.000060:
    p.000060: 3.3.5.
    p.000060:
    p.000060: Providing, according to the applicable regulatory requirements, expedited review and approval/favourable opinion of
    p.000060: minor change(s) in ongoing trials that have the approval/favourable opinion of the IRB/IEC.
    p.000060:
    p.000060: 3.3.6.
    p.000060:
    p.000060: Specifying that no subject should be admitted to a trial before the IRB/IEC issues its written approval/favourable
    p.000060: opinion of the trial.
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    p.000060: justified or not, of benefits associated with participation, or of a retaliatory response from senior members of a
    p.000060: hierarchy in case of refusal to participate. Examples are members of a group with a hierarchical structure, such as
    p.000060: medical, pharmacy, dental, and nursing students, subordinate hospital and laboratory personnel, employees of the
    p.000060: pharmaceutical industry, members of the armed forces, and persons kept in detention. Other vulnerable subjects include
    p.000060: patients with incurable diseases, persons in nursing homes, unemployed or impoverished persons, patients in emergency
    p.000060: situations, ethnic minority groups, homeless persons, nomads, refugees, minors, and those incapable of giving consent.
    p.000060:
    p.000060: 1.62. Well-being (of the trial subjects)
    p.000060:
    p.000060: The physical and mental integrity of the subjects participating in a clinical trial.
    p.000060:
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    p.000060: copy of any amendments to the written information provided to subjects.
    p.000060:
    p.000060: 4.8.12.
    p.000060:
    p.000060: When a clinical trial (therapeutic or non-therapeutic) includes subjects who can only be enrolled in the trial with the
    p.000060: consent of the subject’s legally acceptable representative (e.g., minors, or patients with
    p.000060:
    p.000060:
    p.000060: Guideline for good clinical practice E6(R2)
    p.000060: EMA/CHMP/ICH/135/1995
    p.000060: Page 26/68
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    p.000060: justified or not, of benefits associated with participation, or of a retaliatory response from senior members of a
    p.000060: hierarchy in case of refusal to participate. Examples are members of a group with a hierarchical structure, such as
    p.000060: medical, pharmacy, dental, and nursing students, subordinate hospital and laboratory personnel, employees of the
    p.000060: pharmaceutical industry, members of the armed forces, and persons kept in detention. Other vulnerable subjects include
    p.000060: patients with incurable diseases, persons in nursing homes, unemployed or impoverished persons, patients in emergency
    p.000060: situations, ethnic minority groups, homeless persons, nomads, refugees, minors, and those incapable of giving consent.
    p.000060:
    p.000060: 1.62. Well-being (of the trial subjects)
    p.000060:
    p.000060: The physical and mental integrity of the subjects participating in a clinical trial.
    p.000060:
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    p.000060: The principles established in this guideline may also be applied to other clinical investigations that may have an
    p.000060: impact on the safety and well-being of human subjects.
    p.000060: ADDENDUM
    p.000060:
    p.000060: Since the development of the ICH GCP Guideline, the scale, complexity, and cost of clinical trials have increased.
    p.000060: Evolutions in technology and risk management processes offer new opportunities to increase efficiency and focus on
    p.000060: relevant activities. When the original ICH E6(R1) text was prepared, clinical trials were performed in a largely
    p.000060: paper-based process. Advances in use of electronic data recording and reporting facilitate implementation of other
    p.000060: approaches. For example, centralized monitoring can now offer a greater advantage, to a broader range of trials than is
    p.000060: suggested in the original text. Therefore, this guideline has been amended to encourage implementation of improved and
    p.000060: more efficient approaches to clinical trial design, conduct, oversight, recording and reporting while continuing to
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    p.000060:
    p.000060: 1.65. Validation of Computerized Systems
    p.000060:
    p.000060: A process of establishing and documenting that the specified requirements of a computerized system can be consistently
    p.000060: fulfilled from design until decommissioning of the system or transition to a new system. The approach to validation
    p.000060: should be based on a risk assessment that takes into consideration
    p.000060:
    p.000060: Guideline for good clinical practice E6(R2)
    p.000060: EMA/CHMP/ICH/135/1995
    p.000060: Page 14/68
    p.000060:
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    p.000060: The IRB/IEC should consider the qualifications of the investigator for the proposed trial, as documented by a current
    p.000060: curriculum vitae and/or by any other relevant documentation the IRB/IEC requests.
    p.000060:
    p.000060: 3.1.4.
    p.000060:
    p.000060: The IRB/IEC should conduct continuing review of each ongoing trial at intervals appropriate to the degree of risk to
    p.000060: human subjects, but at least once per year.
    p.000060:
    p.000060: 3.1.5.
    p.000060:
    p.000060: The IRB/IEC may request more information than is outlined in paragraph 4.8.10 be given to subjects when, in the
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    p.000060:
    p.000060: Specifying that the investigator should promptly report to the IRB/IEC:
    p.000060:
    p.000060: a) Deviations from, or changes of, the protocol to eliminate immediate hazards to the trial subjects (see 3.3.7,
    p.000060: 4.5.2, 4.5.4).
    p.000060: b) Changes increasing the risk to subjects and/or affecting significantly the conduct of the trial (see 4.10.2).
    p.000060: c) All adverse drug reactions (ADRs) that are both serious and unexpected.
    p.000060:
    p.000060: d) New information that may affect adversely the safety of the subjects or the conduct of the trial.
    p.000060:
    p.000060: 3.3.9.
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    p.000060: requested by the IRB/IEC.
    p.000060:
    p.000060: 4.10.2.
    p.000060:
    p.000060: The investigator should promptly provide written reports to the sponsor, the IRB/IEC (see 3.3.8) and, where applicable,
    p.000060: the institution on any changes significantly affecting the conduct of the trial, and/or increasing the risk to
    p.000060: subjects.
    p.000060:
    p.000060: 4.11. Safety Reporting
    p.000060:
    p.000060: 4.11.1.
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    p.000060: collection and processing, as well as the collection of information that is essential to decision making.
    p.000060: The methods used to assure and control the quality of the trial should be proportionate to the risks inherent in the
    p.000060: trial and the importance of the information collected. The sponsor should ensure that all aspects of the trial are
    p.000060: operationally feasible and should avoid unnecessary complexity, procedures, and data collection. Protocols, case report
    p.000060: forms, and other operational documents should be clear, concise, and consistent.
    p.000060: The quality management system should use a risk-based approach as described below.
    p.000060:
    p.000060: 5.0.1. Critical process and data identification
    p.000060:
    p.000060: During protocol development, the sponsor should identify those processes and data that are critical to ensure human
    p.000060: subject protection and the reliability of trial results.
    p.000060:
    p.000060: 5.0.2. Risk identification
    p.000060:
    p.000060: The sponsor should identify risks to critical trial processes and data. Risks should be considered at both the system
    p.000060: level (e.g., standard operating procedures, computerized systems, personnel) and clinical trial level (e.g., trial
    p.000060: design, data collection, informed consent process).
    p.000060:
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    p.000060:
    p.000060: Guideline for good clinical practice E6(R2)
    p.000060: EMA/CHMP/ICH/135/1995
    p.000060: Page 30/68
    p.000060:
    p.000060: 5.0.3. Risk evaluation
    p.000060:
    p.000060: The sponsor should evaluate the identified risks, against existing risk controls by considering:
    p.000060:
    p.000060: a) The likelihood of errors occurring.
    p.000060:
    p.000060: b) The extent to which such errors would be detectable.
    p.000060:
    p.000060: c) The impact of such errors on human subject protection and reliability of trial results.
    p.000060:
    p.000060: 5.0.4. Risk control
    p.000060:
    p.000060: The sponsor should decide which risks to reduce and/or which risks to accept. The approach used to reduce risk to an
    p.000060: acceptable level should be proportionate to the significance of the risk. Risk reduction activities may be incorporated
    p.000060: in protocol design and implementation, monitoring plans, agreements between parties defining roles and
    p.000060: responsibilities, systematic safeguards to ensure adherence to standard operating procedures, and training in processes
    p.000060: and procedures.
    p.000060: Predefined quality tolerance limits should be established, taking into consideration the medical and statistical
    p.000060: characteristics of the variables as well as the statistical design of the trial, to identify systematic issues that can
    p.000060: impact subject safety or reliability of trial results. Detection of deviations from the predefined quality tolerance
    p.000060: limits should trigger an evaluation to determine if action is needed.
    p.000060:
    p.000060: 5.0.5. Risk communication
    p.000060:
    p.000060: The sponsor should document quality management activities. The sponsor should communicate quality management activities
    p.000060: to those who are involved in or affected by such activities, to facilitate risk review and continual improvement during
    p.000060: clinical trial execution.
    p.000060:
    p.000060: 5.0.6. Risk review
    p.000060:
    p.000060: The sponsor should periodically review risk control measures to ascertain whether the implemented quality management
    p.000060: activities remain effective and relevant, taking into account emerging knowledge and experience.
    p.000060:
    p.000060: 5.0.7. Risk reporting
    p.000060:
    p.000060: The sponsor should describe the quality management approach implemented in the trial and summarize important deviations
    p.000060: from the predefined quality tolerance limits and remedial actions taken in the clinical study report (ICH E3, Section
    p.000060: 9.6 Data Quality Assurance).
    p.000060:
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    p.000060: When using electronic trial data handling and/or remote electronic trial data systems, the sponsor should:
    p.000060: a) Ensure and document that the electronic data processing system(s) conforms to the sponsor’s established
    p.000060: requirements for completeness, accuracy, reliability, and consistent intended performance (i.e. validation).
    p.000060: ADDENDUM
    p.000060:
    p.000060: The sponsor should base their approach to validation of such systems on a risk assessment that takes into consideration
    p.000060: the intended use of the system and the potential of the system to affect human subject protection and reliability of
    p.000060: trial results.
    p.000060: b) Maintains SOPs for using these systems.
    p.000060:
    p.000060: ADDENDUM
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    p.000060: determine that central monitoring in conjunction with procedures such as investigators’ training and meetings, and
    p.000060: extensive written guidance can assure appropriate conduct of the trial in accordance with GCP. Statistically controlled
    p.000060: sampling may be an acceptable method for selecting the data to be verified.
    p.000060: ADDENDUM
    p.000060:
    p.000060: The sponsor should develop a systematic, prioritized, risk-based approach to monitoring clinical trials. The
    p.000060: flexibility in the extent and nature of monitoring described in this section is intended to permit varied approaches
    p.000060: that improve the effectiveness and efficiency of monitoring. The sponsor may choose on-site monitoring, a combination
    p.000060: of on-site and centralized monitoring, or, where justified, centralized monitoring. The sponsor should document the
    p.000060: rationale for the chosen monitoring strategy (e.g., in the monitoring plan).
    p.000060:
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    p.000060: investigators and others involved in the trial with the information to facilitate their understanding of the rationale
    p.000060: for, and their compliance with, many key features of the protocol, such as the dose, dose frequency/interval, methods
    p.000060: of administration: and safety monitoring procedures. The IB also provides insight to support the clinical management of
    p.000060: the study subjects during the course of the clinical trial. The information should be presented in a concise, simple,
    p.000060: objective, balanced, and non-promotional form that enables a clinician, or potential investigator, to understand it and
    p.000060: make his/her own unbiased risk-benefit assessment of the appropriateness of the proposed trial. For this reason, a
    p.000060: medically qualified person should generally participate in the editing of an IB, but the contents of the IB should be
    p.000060: approved by the disciplines that generated the described data.
    p.000060: This guideline delineates the minimum information that should be included in an IB and provides suggestions for its
    p.000060: layout. It is expected that the type and extent of information available will vary with the stage of development of the
    p.000060: investigational product. If the investigational product is marketed and its pharmacology is widely understood by
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    p.000060:
    p.000060: • The information provided may include the following, as appropriate, if known/available:
    p.000060:
    p.000060: • Species tested
    p.000060:
    p.000060: • Number and sex of animals in each group
    p.000060:
    p.000060: • Unit dose (e.g., milligram/kilogram (mg/kg))
    p.000060:
    p.000060: • Dose interval
    p.000060:
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    p.000060: 3. Institutional Review Board / Independent Ethics Committee (IRB/IEC)
    p.000060: 3.1. Responsibilities
    p.000060:
    p.000060: 3.1.1.
    p.000060:
    p.000060: An IRB/IEC should safeguard the rights, safety, and well-being of all trial subjects. Special attention should be paid
    p.000060: to trials that may include vulnerable subjects.
    p.000060:
    p.000060: 3.1.2.
    p.000060:
    p.000060: The IRB/IEC should obtain the following documents:
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    p.000060: The investigator may provide information on any aspect of the trial, but should not participate in the deliberations of
    p.000060: the IRB/IEC or in the vote/opinion of the IRB/IEC.
    p.000060:
    p.000060: 3.2.6.
    p.000060:
    p.000060: An IRB/IEC may invite nonmembers with expertise in special areas for assistance.
    p.000060:
    p.000060: 3.3. Procedures
    p.000060:
    p.000060: The IRB/IEC should establish, document in writing, and follow its procedures, which should include:
    p.000060:
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    p.000060: a) Nonclinical pharmacology
    p.000060:
    p.000060: A summary of the pharmacological aspects of the investigational product and, where appropriate, its significant
    p.000060: metabolites studied in animals, should be included. Such a summary should incorporate studies that assess potential
    p.000060: therapeutic activity (e.g. efficacy models, receptor binding, and specificity) as well as those that assess safety
    p.000060: (e.g., special studies to assess pharmacological actions other than the intended therapeutic effect(s)).
    p.000060: b) Pharmacokinetics and product metabolism in animals
    p.000060:
    p.000060: A summary of the pharmacokinetics and biological transformation and disposition of the investigational product in all
    p.000060: species studied should be given. The discussion of the findings should address the absorption and the local and
    p.000060: systemic bioavailability of the investigational product and its metabolites, and their relationship to the
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    p.000060:
    p.000060: • Repeated dose
    p.000060:
    p.000060: • Carcinogenicity
    p.000060:
    p.000060: • Special studies (e.g. irritancy and sensitisation)
    p.000060:
    p.000060: • Reproductive toxicity
    p.000060:
    p.000060: • Genotoxicity (mutagenicity)
    p.000060:
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    p.000060: indications in subgroups may provide a clear presentation of the data. Tabular summaries of adverse drug reactions for
    p.000060: all the clinical trials (including those for all the studied indications) would be useful. Important differences in
    p.000060: adverse drug reaction patterns/incidences across indications or subgroups should be discussed.
    p.000060: The IB should provide a description of the possible risks and adverse drug reactions to be anticipated on the basis of
    p.000060: prior experiences with the product under investigation and with related products. A description should also be provided
    p.000060: of the precautions or special monitoring to be done as part of the investigational use of the product(s).
    p.000060: c) Marketing experience
    p.000060:
    p.000060:
    p.000060: Guideline for good clinical practice E6(R2)
    p.000060: EMA/CHMP/ICH/135/1995
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    p.000060: investigational product(s), and the anticipated prophylactic, therapeutic, or diagnostic indication(s). Finally, the
    p.000060: introductory statement should provide the general approach to be followed in evaluating the investigational product.
    p.000060:
    p.000060: 7.3.4. Physical, chemical, and pharmaceutical properties and formulation
    p.000060:
    p.000060: A description should be provided of the investigational product substance(s) (including the chemical and/or structural
    p.000060: formula(e)), and a brief summary should be given of the relevant physical, chemical, and pharmaceutical properties.
    p.000060: To permit appropriate safety measures to be taken in the course of the trial, a description of the formulation(s) to be
    p.000060: used, including excipients, should be provided and justified if clinically relevant. Instructions for the storage and
    p.000060: handling of the dosage form(s) should also be given.
    p.000060: Any structural similarities to other known compounds should be mentioned.
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    p.000060: (i.e. in emergency situations).
    p.000060:
    p.000060: 3.1.8.
    p.000060:
    p.000060: The IRB/IEC should review both the amount and method of payment to subjects to assure that neither presents problems of
    p.000060: coercion or undue influence on the trial subjects. Payments to a subject should be prorated and not wholly contingent
    p.000060: on completion of the trial by the subject.
    p.000060:
    p.000060: 3.1.9.
    p.000060:
    p.000060: The IRB/IEC should ensure that information regarding payment to subjects, including the methods, amounts, and schedule
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    p.000060: An adverse reaction, the nature or severity of which is not consistent with the applicable product information (e.g.,
    p.000060: Investigator's Brochure for an unapproved investigational product or package insert/summary of product characteristics
    p.000060: for an approved product) (see the ICH Guideline for Clinical Safety Data Management: Definitions and Standards for
    p.000060: Expedited Reporting).
    p.000060:
    p.000060: 1.61. Vulnerable subjects
    p.000060:
    p.000060: Individuals whose willingness to volunteer in a clinical trial may be unduly influenced by the expectation, whether
    p.000060: justified or not, of benefits associated with participation, or of a retaliatory response from senior members of a
    p.000060: hierarchy in case of refusal to participate. Examples are members of a group with a hierarchical structure, such as
    p.000060: medical, pharmacy, dental, and nursing students, subordinate hospital and laboratory personnel, employees of the
    p.000060: pharmaceutical industry, members of the armed forces, and persons kept in detention. Other vulnerable subjects include
    p.000060: patients with incurable diseases, persons in nursing homes, unemployed or impoverished persons, patients in emergency
    p.000060: situations, ethnic minority groups, homeless persons, nomads, refugees, minors, and those incapable of giving consent.
    p.000060:
    p.000060: 1.62. Well-being (of the trial subjects)
    p.000060:
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    p.000060: 3.1. Responsibilities
    p.000060:
    p.000060: 3.1.1.
    p.000060:
    p.000060: An IRB/IEC should safeguard the rights, safety, and well-being of all trial subjects. Special attention should be paid
    p.000060: to trials that may include vulnerable subjects.
    p.000060:
    p.000060: 3.1.2.
    p.000060:
    p.000060: The IRB/IEC should obtain the following documents:
    p.000060:
...