0A4F4F9BD490A749D5437F821CF06DF1
Manual for Submission of Modifications, Amendments, Suspensions, and Cancellations on DICD (2015)
http://portal.anvisa.gov.br/documents/33912/2785629/Manual+Para+Submiss%C3%A3o+de+Modifica%C3%A7%C3%B5es%2C+Emendas%2C+Suspens%C3%B5es+e+Cancelamentos/431fa7ef-24e6-4b14-80b9-ce68bccc24d8
http://leaux.net/URLS/ConvertAPI Text Files/7C5D2FF3955E4D3421604363BB745DBE.en.txt
Examining the file media/Synopses/7C5D2FF3955E4D3421604363BB745DBE.html:
This file was generated: 2020-07-15 04:04:54
| 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
Health / Drug Usage
Searching for indicator drug:
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p.000011: petition is 80124 - CLINICAL TRIALS - Cancellation of Clinical Trial Protocol due to transfer
p.000011: global responsibility - Medical Devices. In the specific case of cancellation on request,
p.000011: requirements that must be presented for the monitoring plan and for the
p.000011: risk minimization / mitigation measures for clinical trial participants.
p.000011: For suspensions, the subject to be used is 80118 - CLINICAL TRIALS - Temporary suspension of
p.000011: Clinical Trial - Medical Devices. By definition, these are temporary in nature and can be reversed
p.000011: with the subject of petition 80119 - CLINICAL TRIALS - Reactivation of Suspended Clinical Trials Protocol -
p.000011: Medical Devices. The reactivation depends on prior approval by Anvisa.
p.000012: 12
p.000012: Manual for Submitting Modifications, Amendments, Suspensions and Cancellations
p.000012: 5. References
p.000012: BRAZIL. ANVISA. National Health Surveillance Agency. RDC Resolution No. 10, of February 20, 2015,
p.000012: published in the D.O.U. March 3, 2015. Provides for the regulation for conducting tests
p.000012: medical devices in Brazil. Official Diary of the Union; Executive Branch, of March 3, 2015.
p.000012: EUROPEAN COMMISSION. Communication from the Commission - Detailed guidance on the request to the competent authorities
p.000012: for authorization of a clinical trial on a medicinal product for human use, the notification of substantial amendments
p.000012: and the declaration of the end of the trial (CT-1). Available in:
p.000012: http://ec.europa.eu/health/files/eudralex/vol- 10 / 2010_c82_01 / 2010_c82_01_en.pdf. Accessed on November 20, 2014.
p.000012: FOOD AND DRUG ADMINISTRATION. IND Application Reporting: Protocol Amendments. Available
p.000012: in:
p.000012: http://www.fda.gov/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandAppr
p.000012: oved / ApprovalApplications / InvestigationalNewDrugINDApplication / ucm362503.htm.
p.000012: Accessed on November 19, 2014.
p.000012: HEALTH CANADA. Guidance Document For Clinical Trial Sponsors: Clinical Trial Applications.
p.000012: Available at: http://www.hc-sc.gc.ca/dhp-mps/prodpharma/applic-
p.000012: demande / guide-ld / clini / ctdcta_ctddec-eng.php. Accessed on November 21, 2014.
p.000013: 13
p.000013: Manual for Submitting Modifications, Amendments, Suspensions and Cancellations
p.000013: Attachments
p.000013: ANNEX I
p.000013: PETITION FORM FOR SUBSTANTIAL MODIFICATION OF THE MEDICAL DEVICE CLINICAL DEVELOPMENT DOSSIER (DICD)
p.000013: Document Identification
p.000013: National Health Surveillance Agency
p.000013: Coordination of Clinical Research in Correlates and Food Petition Form for Substantial Modification of Dossier
p.000013: Medical Device Development (DICD)
p.000013: (For use by the receiving agency)
p.000013: Process number
p.000001: 1
p.000001: Hours (Day / Month / Year) 2 / /
p.000001: Company Data
p.000001: Requestor Number
p.000001: Authorization / Registration
p.000001: 3 4
p.000001: 5 Manufacturer 6
p.000001: Authorization / Registration Number
p.000001: DICD data
p.000001: 7 Process number of the Medical Device Clinical Development (DICD) dossier:
p.000001: Modification Type:
p.000001: a) Inclusion of clinical trial protocol (s) not foreseen or different (s) from that (s) previously
p.000001: established in the initial development plan?
p.000001: b) Exclusion of clinical trial protocol (s)?
p.000001: c) Changes that potentially have an impact on quality or
p.000001: 8 product safety under investigation?
p.000001: The. If yes, see item 9.
...
Social / Trade Union Membership
Searching for indicator union:
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p.000011: It is important to remember that the cancellation only applies to clinical trial protocols that have already been initiated by the
p.000011: sponsor. If the protocol is provided for in the DICD, but has not yet been started, the
p.000011: exclusion from the protocol, as provided in the previous section.
p.000011: If the cancellation is at the company's request, including cases of cancellation for security reasons, you must
p.000011: the subject of petition 80123 - Cancellation of Clinical Trial Protocol on request -
p.000011: Medical Devices; if the cancellation occurs by global transfer of responsibility, the matter of
p.000011: petition is 80124 - CLINICAL TRIALS - Cancellation of Clinical Trial Protocol due to transfer
p.000011: global responsibility - Medical Devices. In the specific case of cancellation on request,
p.000011: requirements that must be presented for the monitoring plan and for the
p.000011: risk minimization / mitigation measures for clinical trial participants.
p.000011: For suspensions, the subject to be used is 80118 - CLINICAL TRIALS - Temporary suspension of
p.000011: Clinical Trial - Medical Devices. By definition, these are temporary in nature and can be reversed
p.000011: with the subject of petition 80119 - CLINICAL TRIALS - Reactivation of Suspended Clinical Trials Protocol -
p.000011: Medical Devices. The reactivation depends on prior approval by Anvisa.
p.000012: 12
p.000012: Manual for Submitting Modifications, Amendments, Suspensions and Cancellations
p.000012: 5. References
p.000012: BRAZIL. ANVISA. National Health Surveillance Agency. RDC Resolution No. 10, of February 20, 2015,
p.000012: published in the D.O.U. March 3, 2015. Provides for the regulation for conducting tests
p.000012: medical devices in Brazil. Official Diary of the Union; Executive Branch, of March 3, 2015.
p.000012: EUROPEAN COMMISSION. Communication from the Commission - Detailed guidance on the request to the competent authorities
p.000012: for authorization of a clinical trial on a medicinal product for human use, the notification of substantial amendments
p.000012: and the declaration of the end of the trial (CT-1). Available in:
p.000012: http://ec.europa.eu/health/files/eudralex/vol- 10 / 2010_c82_01 / 2010_c82_01_en.pdf. Accessed on November 20, 2014.
p.000012: FOOD AND DRUG ADMINISTRATION. IND Application Reporting: Protocol Amendments. Available
p.000012: in:
p.000012: http://www.fda.gov/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandAppr
p.000012: oved / ApprovalApplications / InvestigationalNewDrugINDApplication / ucm362503.htm.
p.000012: Accessed on November 19, 2014.
p.000012: HEALTH CANADA. Guidance Document For Clinical Trial Sponsors: Clinical Trial Applications.
p.000012: Available at: http://www.hc-sc.gc.ca/dhp-mps/prodpharma/applic-
p.000012: demande / guide-ld / clini / ctdcta_ctddec-eng.php. Accessed on November 21, 2014.
p.000013: 13
p.000013: Manual for Submitting Modifications, Amendments, Suspensions and Cancellations
p.000013: Attachments
p.000013: ANNEX I
p.000013: PETITION FORM FOR SUBSTANTIAL MODIFICATION OF THE MEDICAL DEVICE CLINICAL DEVELOPMENT DOSSIER (DICD)
p.000013: Document Identification
p.000013: National Health Surveillance Agency
p.000013: Coordination of Clinical Research in Correlates and Food Petition Form for Substantial Modification of Dossier
p.000013: Medical Device Development (DICD)
p.000013: (For use by the receiving agency)
p.000013: Process number
p.000001: 1
p.000001: Hours (Day / Month / Year) 2 / /
p.000001: Company Data
p.000001: Requestor Number
p.000001: Authorization / Registration
p.000001: 3 4
p.000001: 5 Manufacturer 6
...
Social / education
Searching for indicator educational:
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p.000002: Superintendence of Correlates and Food
p.000002: João Tavares Neto
p.000002: Coordination of Clinical Research in Correlates and Food
p.000002: Alessandro Ferreira do Nascimento
p.000002: Responsible for the manual:
p.000002: Alessandro Ferreira do Nascimento
p.000002: Collaboration:
p.000002: Adriane Alves de Oliveira
p.000002: André Luís Carvalho Santos Souza Bruno de Paula Coutinho
p.000002: Bruno Zago Franca Diniz Candida Luci Pessoa and Silva Carla Abrahao Brichesi Carlos Augusto Martins Netto Claudio
p.000002: Nishizawa
p.000002: Fanny Nascimento Moura Fernando Casseb Flosi Flávia Regina Souza Sobral
p.000002: Janaina Lopes Domingos Kellen from Rocio Malaman Miriam Motizuki Onishi Patrícia Ferrari Andreotti Ricardo Eccard da
p.000002: Silva Sônia Costa e Silva
p.000002: summary
p.000002: 1. Introduction
p.000002: 2
p.000002: 2. Modifications to the DICD
p.000003: 3
p.000003: 3. Amendments to the Protocol
p.000006: 6
p.000006: 4. Suspensions and Cancellations 10
p.000006: 5. References
p.000012: 12
p.000012: Attachments
p.000013: 13
p.000002: 2
p.000002: Manual for Submitting Modifications, Amendments, Suspensions and Cancellations
p.000002: 1. Introduction
p.000002: Without prejudice to the existing provisions in the legal provisions, this manual aims to guide
p.000002: submissions of modifications to the Medical Device Clinical Investigation Dossier (DICD), amendments to
p.000002: clinical protocols, suspensions and cancellations, as described in chapters III, IV and V of RDC 10/2015.
p.000002: The document is broken down into specific sections for each type of change. The changes are described in detail,
p.000002: with examples and the respective specific petition matters.
p.000002: This manual is a non-binding regulatory measure adopted as a complement to legislation
p.000002: health, with the educational purpose of providing guidance on routines and procedures for
p.000002: compliance with legislation, and is not intended to expand or restrict technical requirements or
p.000002: established administrative procedures.
p.000002: The guidelines contained in this manual are subject to receiving suggestions from society in the form and for a period to be
p.000002: established by Anvisa. Thus, this manual is open to contributions, with a process of
p.000002: recurring review. The suggestions received will be evaluated to support the revision of the manual and consequent
p.000002: publication of a new version with each update.
p.000002: We emphasize that the situations and examples contained in this manual are illustrative, but in a
p.000002: restrictive or exhaustive. Each situation must be assessed “on a case-by-case” basis, and contexts that
p.000002: just described must always be accompanied by justifications.
p.000003: 3
p.000003: Manual for Submitting Modifications, Amendments, Suspensions and Cancellations
p.000003: 2. Modifications to the DICD
p.000003: Modifications to the DICD, in the context of RDC 10/2015, are defined as any changes made in the global context
p.000003: DICD - especially those related to the quality of the product under investigation - or modifications
p.000003: administrative tasks, such as form updates.
p.000003: All modifications must be submitted to Anvisa: the substantial modifications must be
p.000003: when it is carried out, and its implementation must await a manifestation from this agency, while
p.000003: non-substantial ones should be presented as part of the development security update report
p.000003: medical device under investigation. Details on the application procedures will be
p.000003: described below.
p.000003: Substantial changes can be filed at any time after the initial submission of the DICD, including
p.000003: before the final manifestation of Anvisa.
...
Social / philosophical differences/differences of opinion
Searching for indicator opinion:
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p.000003: The following are examples of substantial modifications related to product quality or safety under
p.000003: investigation. We emphasize that the lists below are illustrative only, not exhausting all possibilities:
p.000004: 4
p.000004: Manual for Submitting Modifications, Amendments, Suspensions and Cancellations
p.000004: 1. Substantial changes:
p.000004: The. Changes related to the design of the medical device;
p.000004: B. Changes related to the design of the medical device;
p.000004: ç. Inclusion of new presentation;
p.000004: d. Changes related to the expiration date or care of conservation of the product under investigation;
p.000004: and. Expansion of use;
p.000004: f. Inclusion of a new therapeutic indication;
p.000004: 2. Non-substantial changes:
p.000004: The. Update of the DICD Petition Form that does not foresee the changes mentioned above;
p.000004: B. Change in labeling of the product under investigation;
p.000004: ç. Update of instructions for use of the comparator medical device;
p.000004: d. Spell check in documents;
p.000004: and. Small clarifications.
p.000004: To modify any information contained in the Form, simply submit a new form with
p.000004: the updated information and document describing the justifications for each change. Amendment to non-clinical trial
p.000004: constitutes modification, as explained in the next section. It is recommended that substantial modifications be
p.000004: accompanied by a comparative table, if applicable.
p.000004: The applicant must update the forms whenever there is a change in the data contained therein (and not only
p.000004: time of submission of annual reports, for example), as these data reflect the publicity of the trials
p.000004: on the Anvisa website and will be used to guide inspections in Good Practices
p.000004: Clinics. The updating of this form does not depend on a prior opinion by the Agency.
p.000005: 5
p.000005: Manual for Submitting Modifications, Amendments, Suspensions and Cancellations
p.000005: Substantial modifications must constitute a secondary petition to the primary petition for submission of the
p.000005: Investigative Medical Device DICD. The inclusion and exclusion of clinical trials has important
p.000005: own, namely:
p.000005: • 80107 - CLINICAL TRIALS - Modification of DICD - Inclusion of clinical trial protocol not provided for in the plan
p.000005: initial development
p.000005: o The inclusion of clinical trial protocols that were already provided for in the initial development plan should
p.000005: be carried out using specific subject, according to the Manual for Submission of Development Dossier
p.000005: Medical Device Clinician (DICD) and Specific Clinical Trial Dossier.
p.000005: • 80108 - CLINICAL TRIALS - Modification of DICD - Exclusion of clinical trial protocol
p.000005: Changes that potentially impact the quality or safety of the Medical Device in
p.000005: Research, simulated device, active comparator or placebo, according to the examples above, should use the
p.000005: petition subject 80109 - CLINICAL TRIALS - DICD modification - Alteration that potentially generates
p.000005: impact on the quality or safety of the product under investigation. Must be presented
p.000005: (comparative) documentation of the initial situation and the proposal accompanied by technical and
p.000005: any additional documents required to prove that the change will not impact development
p.000005: product.
p.000005: It is worth mentioning that it is the sponsor's responsibility to evaluate and classify the changes prior to
p.000005: submission to the agency, so that a risk / benefit analysis and need for
...
General/Other / participants in a control group
Searching for indicator placebo:
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p.000002: publication of a new version with each update.
p.000002: We emphasize that the situations and examples contained in this manual are illustrative, but in a
p.000002: restrictive or exhaustive. Each situation must be assessed “on a case-by-case” basis, and contexts that
p.000002: just described must always be accompanied by justifications.
p.000003: 3
p.000003: Manual for Submitting Modifications, Amendments, Suspensions and Cancellations
p.000003: 2. Modifications to the DICD
p.000003: Modifications to the DICD, in the context of RDC 10/2015, are defined as any changes made in the global context
p.000003: DICD - especially those related to the quality of the product under investigation - or modifications
p.000003: administrative tasks, such as form updates.
p.000003: All modifications must be submitted to Anvisa: the substantial modifications must be
p.000003: when it is carried out, and its implementation must await a manifestation from this agency, while
p.000003: non-substantial ones should be presented as part of the development security update report
p.000003: medical device under investigation. Details on the application procedures will be
p.000003: described below.
p.000003: Substantial changes can be filed at any time after the initial submission of the DICD, including
p.000003: before the final manifestation of Anvisa.
p.000003: For the purposes of the Resolution, substantial changes consist of:
p.000003: I - Inclusion of clinical trial protocol (s) not foreseen or different (s) from that (s) previously
p.000003: established in the initial development plan;
p.000003: II - Exclusion of clinical trial protocol (s);
p.000003: III - Changes that potentially impact the quality or safety of the Medical Device under Investigation,
p.000003: active comparator, placebo or simulated device.
p.000003: It is the sponsor's responsibility to assess whether a modification is considered substantial or not and its
p.000003: impact on clinical development. This assessment should always be done on a case-by-case basis, based on the criteria
p.000003: above and in the examples below.
p.000003: The following are examples of substantial modifications related to product quality or safety under
p.000003: investigation. We emphasize that the lists below are illustrative only, not exhausting all possibilities:
p.000004: 4
p.000004: Manual for Submitting Modifications, Amendments, Suspensions and Cancellations
p.000004: 1. Substantial changes:
p.000004: The. Changes related to the design of the medical device;
p.000004: B. Changes related to the design of the medical device;
p.000004: ç. Inclusion of new presentation;
p.000004: d. Changes related to the expiration date or care of conservation of the product under investigation;
p.000004: and. Expansion of use;
p.000004: f. Inclusion of a new therapeutic indication;
p.000004: 2. Non-substantial changes:
p.000004: The. Update of the DICD Petition Form that does not foresee the changes mentioned above;
p.000004: B. Change in labeling of the product under investigation;
p.000004: ç. Update of instructions for use of the comparator medical device;
p.000004: d. Spell check in documents;
p.000004: and. Small clarifications.
p.000004: To modify any information contained in the Form, simply submit a new form with
p.000004: the updated information and document describing the justifications for each change. Amendment to non-clinical trial
p.000004: constitutes modification, as explained in the next section. It is recommended that substantial modifications be
p.000004: accompanied by a comparative table, if applicable.
p.000004: The applicant must update the forms whenever there is a change in the data contained therein (and not only
p.000004: time of submission of annual reports, for example), as these data reflect the publicity of the trials
p.000004: on the Anvisa website and will be used to guide inspections in Good Practices
p.000004: Clinics. The updating of this form does not depend on a prior opinion by the Agency.
p.000005: 5
p.000005: Manual for Submitting Modifications, Amendments, Suspensions and Cancellations
p.000005: Substantial modifications must constitute a secondary petition to the primary petition for submission of the
p.000005: Investigative Medical Device DICD. The inclusion and exclusion of clinical trials has important
p.000005: own, namely:
p.000005: • 80107 - CLINICAL TRIALS - Modification of DICD - Inclusion of clinical trial protocol not provided for in the plan
p.000005: initial development
p.000005: o The inclusion of clinical trial protocols that were already provided for in the initial development plan should
p.000005: be carried out using specific subject, according to the Manual for Submission of Development Dossier
p.000005: Medical Device Clinician (DICD) and Specific Clinical Trial Dossier.
p.000005: • 80108 - CLINICAL TRIALS - Modification of DICD - Exclusion of clinical trial protocol
p.000005: Changes that potentially impact the quality or safety of the Medical Device in
p.000005: Research, simulated device, active comparator or placebo, according to the examples above, should use the
p.000005: petition subject 80109 - CLINICAL TRIALS - DICD modification - Alteration that potentially generates
p.000005: impact on the quality or safety of the product under investigation. Must be presented
p.000005: (comparative) documentation of the initial situation and the proposal accompanied by technical and
p.000005: any additional documents required to prove that the change will not impact development
p.000005: product.
p.000005: It is worth mentioning that it is the sponsor's responsibility to evaluate and classify the changes prior to
p.000005: submission to the agency, so that a risk / benefit analysis and need for
p.000005: supporting documentation. For greater agility and ease in submitting changes to analysis, you can
p.000005: Attachment I of this manual must be completed and submitted together with the other documents.
p.000005: Non-substantial modifications do not have a specific petition subject and should be integrated into the petition
p.000005: 80121 - CLINICAL TRIALS - Medical Device Clinical Development Report.
p.000006: 6
p.000006: Manual for Submitting Modifications, Amendments, Suspensions and Cancellations
p.000006: 3. Amendments to the Protocol
p.000006: Amendments, in the context of RDC 10/2015, are defined as any changes made to the clinical protocol (s),
p.000006: whether they are substantial or not.
p.000006: All amendments must be submitted to Anvisa, as follows:
p.000006: • Substantial ones must be filed when they are carried out and their implementation must wait
p.000006: manifestation of this agency.
p.000006: • Nonsubstantials must be presented as part of the clinical trial annual report.
p.000006: Substantial amendments can be filed at any time after the inclusion of the first protocol
p.000006: to the DICD, even before the final manifestation of Anvisa.
...
Orphaned Trigger Words
p.000006: of individuals;
p.000006: • Change in the scientific value of the clinical trial protocol;
p.000006: Conceptually, a clinical trial will have scientific value if:
p.000006: a) Evaluate a therapeutic or diagnostic intervention that can lead to improvements in health or
p.000006: quality of life; or
p.000006: b) It is a preliminary etiological, pathophysiological or epidemiological study to develop such an intervention; or
p.000006: c) Test a hypothesis that can generate important knowledge about the structure or the
p.000006: functioning of human biological systems, even if that knowledge has no practical ramifications
p.000006: immediate.
p.000007: 7
p.000007: Manual for Submitting Modifications, Amendments, Suspensions and Cancellations
p.000007: Thus, examples of changes in scientific value are the change in the comparability profile (active comparator
p.000007: for historical series, for example), the insertion of additional experimental arms or changes in the
p.000007: statistical analysis.
p.000007: It is the sponsor's responsibility to assess whether an amendment is considered substantial or not and its impact
p.000007: in clinical development. This assessment should always be done on a case-by-case basis, based on the above criteria.
p.000007: Here are some examples for each category of amendments, including examples of situations that do not constitute an amendment.
p.000007: We emphasize that the list below is only illustrative, not exhausting all possibilities.
p.000007: 1. Substantial Amendments:
p.000007: The. Changing the primary objective of the clinical protocol;
p.000007: B. Change in primary and / or secondary outcomes;
p.000007: ç. Use of a new parameter to measure the primary outcome;
p.000007: d. New data or interpretation of non-clinical data, which may have an impact on risk analysis;
p.000007: and. Change in the criteria established for the termination of the protocol, even though it has already ended;
p.000007: f. Addition of experimental arms;
p.000007: g. Change in the number of participants expected for the study;
p.000007: H. Change in the inclusion and exclusion criteria;
p.000007: i. Reduction in the number of scheduled visits;
p.000007: j. Change in diagnostic procedures or medical monitoring;
p.000007: k. Removal of the Independent Data Monitoring Committee initially planned for the study;
p.000007: l. Change in the product under investigation;
p.000007: m. Change in the procedure adopted to subject the research subject to that of the product under investigation;
p.000007: n. Change in the design of the clinical protocol;
p.000007: O. Change in the initial statistical analysis plan.
p.000007: 2. Non-substantial amendments:
p.000008: 8
p.000008: Manual for Submitting Modifications, Amendments, Suspensions and Cancellations
p.000008: The. Alteration, addition or removal of exploratory outcomes;
p.000008: B. Proposal for the extension or continuation of the research with the same recruited participants, without
p.000008: changes in the design, methods and objectives of the original project; occurring such changes, should be
p.000008: another research protocol was submitted, not an amendment;
p.000008: ç. Change in the documentation used by the study team to capture and record the data;
p.000008: d. Addition of preventive security monitoring, unrelated to any security announcements
p.000008: issued.
p.000008: and. Small clarifications to the protocol;
p.000008: f. Spell check;
p.000008: g. Update of Clinical Trial Presentation Form.
p.000008: The applicant must update the Clinical Trial Submission Form whenever there is a change in the
p.000008: data contained therein (and not just when submitting annual reports, for example), as these data
...
p.000009: amendments to the analysis, Appendix II of this manual can be completed and submitted with the other documents. The subject
p.000009: specific request is 80113 - CLINICAL TRIALS - Substantial Amendment to Clinical Protocol - Medical Devices
p.000009: Non-substantial amendments do not have a specific petition subject, and must be integrated into the petition
p.000009: 80120 - CLINICAL TRIALS - Annual Clinical Trial Protocol Monitoring Report - Devices
p.000009: Doctors, with the same documents required for substantial amendments.
p.000010: 10
p.000010: Manual for Submitting Modifications, Amendments, Suspensions and Cancellations
p.000010: 4. Suspensions and Cancellations
p.000010: • For DICD:
p.000010: A DICD can be canceled or suspended. These situations have their own petition issues and should not
p.000010: constitute none of the aforementioned modification requests. After decision of
p.000010: suspension or cancellation, the sponsor must notify Anvisa within a maximum period of 15 calendar days.
p.000010: If the cancellation occurs at the company's request, including cases of cancellation for security reasons, it must be
p.000010: used the subject of petition 80114 - CLINICAL TRIALS - Cancellation of DICD on request; if the
p.000010: cancellation occurs by global transfer of responsibility, the subject of petition is 80115 -
p.000010: CLINICAL TRIALS - Cancellation of DICD due to global transfer of responsibility
p.000010: by the Responsible Sponsor. It is important to remember that cancellations, under the terms of RDC 10/2015, are
p.000010: definitive, with no possibility of further reactivation, and that once a DICD has been canceled, no clinical trial
p.000010: related to it may be continued in the country.
p.000010: In the specific case of cancellation of DICD on request, the requirements that must be submitted for the
p.000010: monitoring plan and risk minimization / mitigation measures for trial participants
p.000010: ongoing clinical trials.
p.000010: It is important to remember that, for a DICD, cancellation can occur at any time, even if it has not yet
p.000010: been evaluated.
p.000010: For suspensions, the subject to be used is 80116 - CLINICAL TRIALS - Temporary suspension of DICD. Per
p.000010: definition, these have a temporary character and can be reversed with the subject of petition 80117 -
p.000010: CLINICAL TRIALS - Reactivation of suspended DICD. The reactivation depends on prior approval by Anvisa.
p.000011: 11
p.000011: Manual for Submitting Modifications, Amendments, Suspensions and Cancellations
p.000011: • For a Clinical Trial:
p.000011: Like the DICD, an individual clinical trial can also be canceled or suspended. These situations have issues
p.000011: own petitions and should not constitute any of the petitions for amendments mentioned above. After
p.000011: decision of suspension or cancellation, the sponsor must notify Anvisa within a maximum period of 15 calendar days,
p.000011: except in cases of temporary suspension as an immediate security measure, when the period is 7 calendar days from
p.000011: from the date of suspension. In addition, cancellations under RDC 10/2015 are final,
p.000011: with no possibility of further reactivation.
p.000011: It is important to remember that the cancellation only applies to clinical trial protocols that have already been initiated by the
p.000011: sponsor. If the protocol is provided for in the DICD, but has not yet been started, the
p.000011: exclusion from the protocol, as provided in the previous section.
p.000011: If the cancellation is at the company's request, including cases of cancellation for security reasons, you must
p.000011: the subject of petition 80123 - Cancellation of Clinical Trial Protocol on request -
...
p.000015: 15
p.000015: Manual for Submitting Modifications, Amendments, Suspensions and Cancellations
p.000015: ANNEX II
p.000015: PETITION FORM FOR SUBSTANTIAL AMENDMENT TO CLINICAL TEST PROTOCOL
p.000015: Document Identification
p.000015: National Health Surveillance Agency
p.000015: Coordination of Clinical Research in Correlates and Food Petition Form for Substantial Amendment to Protocol of
p.000015: Clinical Trial
p.000015: (For use by the receiving agency)
p.000015: Process number
p.000001: 1
p.000001: Hours (Day / Month / Year) 2 / /
p.000001: Company Data
p.000001: Requestor Number
p.000001: Authorization / Registration
p.000001: 3 4
p.000001: 5 Manufacturer 6
p.000001: Authorization / Registration Number
p.000001: Clinical Protocol Data
p.000001: 7 Process number of the clinical trial protocol and its linked DICD:
p.000001: 8 Subject of the Petition (codes and description) 9 Factual Generator (datavisa)
p.000001: 10 Title and Code of the Clinical Trial Protocol 11 Protocol No. (Version and date)
p.000001: 12 Trial Phase
p.000001: I () II () III () IV ()
p.000001: () Feasibility () Pivotal
p.000001: () others, specify
p.000001: Substantial Splice Type
p.000001: a) Change in the clinical trial protocol that interferes with the safety or physical or mental integrity of the
p.000001: participants?
p.000001: B) Change in the scientific value of the clinical trial protocol?
p.000001: a) () Yes () No
p.000001: b) () Yes () No
p.000016: 16
p.000016: Manual for Submitting Modifications, Amendments, Suspensions and Cancellations
p.000016: Reasons for Substantial Amendment:
p.000016: a) Changing the primary objective of the clinical protocol;
p.000016: b) Change in primary and / or secondary outcomes;
p.000016: c) Use of a new parameter to measure the primary outcome;
p.000016: d) New data or interpretation on non-clinical data, which may have an impact on the analysis of
p.000016: risk;
p.000016: e) Change in the criteria established for the termination of the protocol, even if it has already ended;
p.000016: f) Addition of experimental arms;
p.000016: g) Change in the number of participants expected for the study;
p.000016: h) Change in the inclusion and exclusion criteria;
p.000016: i) Reduction in the number of scheduled visits;
p.000016: j) Change in diagnostic or monitoring procedures
p.000016: 14 doctors;
p.000016: k) Removal of the Independent Data Monitoring Committee initially planned for the study;
p.000016: l) Change in the product under investigation;
p.000016: m) Change in the procedure adopted to subject the research subject to that of the product under investigation;
p.000016: n) Change in the design of the clinical protocol;
p.000016: o) Change in the initial statistical analysis plan.
p.000016: p) Other changes?
p.000016: The. If yes, specify:
p.000016: a) () Yes () No
p.000016: b) () Yes () No
p.000016: c) () Yes () No
p.000016: d) () Yes () No
p.000016: e) () Yes () No
p.000016: f) () Yes () No
p.000016: g) () Yes () No
p.000016: h) () Yes () No
p.000016: i) () Yes () No
p.000016: j) () Yes () No
p.000016: k) () Yes () No
p.000016: l) () Yes () No
p.000016: m) () Yes () No
p.000016: n) () Yes () No
p.000016: o) () Yes () No
...
Appendix
Indicator List
| Indicator | Vulnerability |
|---|
| drug | Drug Usage |
| educational | education |
| opinion | philosophical differences/differences of opinion |
| placebo | participants in a control group |
| union | Trade Union Membership |
Indicator Peers (Indicators in Same Vulnerability)
Trigger Words
risk
Applicable Type / Vulnerability / Indicator Overlay for this Input