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Resources: For Accreditation - Evaluation Instrument
Table of Contents
Regulatory and guidance references
- DHHS: 45 CFR 46.102(d), 45 CFR 46.102 (f)
- DOJ: 28 CFR 512.11 (a)(6)
- FDA: 21 CFR 50.3(a), 21 CFR 50.3(c), 21 CFR 50.3(g), 21 CFR 50.3(j), 21 CFR 56.102(c), 21 CFR 56.102(l)
- ICH-GCP: 2.7, 2.8, 4.1.1 – 4.1.4, 4.3.1, 4.3.2, 4.4.1 – 4.4.3, 4.5.1 – 4.5.4, 4.6.1 – 4.6.6, 4.7, 4.9.1-4.9.5
- VA: 38 CFR 16.102(d), 38 CFR 16.102 (f)
- AAHRPP Tip Sheet: Following the Guideline of the International Conference on Harmonisation – Good Clinical Practice (E6)
Required written materials
- Essential requirements:
- Policies and procedures pertaining to Element I.1.D. that address essential requirements. If the same policies and procedures are provided to researchers and research staff, simply reference those documents in the application for this Element. If there are additional materials, such as an Investigator Handbook or Web pages for researchers, that are not included in the materials used to support Element I.1.D, but are in support of Element III.2.A., include them here.
- When following the ICH-GCP (E6) guideline:
- Policies and procedures describe that the researcher and research staff are knowledgeable about the following responsibilities:
- The researcher provides evidence of his or her qualifications through up-to-date curriculum vitae or other relevant documentation requested by the sponsor, the IRB or EC, or the regulatory authority.
- The researcher is familiar with the appropriate use of the investigational product, as described in the protocol, in the current investigator brochure, in the product information, and in other information sources provided by the sponsor.
- A qualified physician (or dentist, when appropriate), who is a researcher or a co-researcher for the clinical trial, is responsible for all clinical trial-related medical (or dental) decisions (not applicable to independent IRBs or ECs).
- During and following a participant’s participation in a clinical trial, the researcher ensures that adequate medical care is provided to a participant for any adverse events, including clinically significant laboratory values, related to the clinical trial (not applicable to independent IRBs or ECs).
- The researcher ensures the accuracy, completeness, legibility, and timeliness of the data reported to the sponsor.
Common types of materials that may be used to meet the element
- Researcher manual
- Researchers and research staff are qualified by training and experience for their roles and responsibilities in conducting research.
- Researchers and research staff know which laws, regulations, codes, and guidance govern their research studies and are knowledgeable about requirements pertaining to specific research studies.
- Researchers and research staff are knowledgeable about the organization’s policies and procedures.