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Note: This hidden slide will not show in a slide presentation. Remove before providing slide deck to sites. Tool Summary Sheet v2.0 - 2013-03-26 ICH E6 Good Clinical Practice Guidance and 45 CFR 46: Protection of Human Subjects Investigator Responsibilities and Good Clinical Practice (GCP) Note that this is a general slide presentation designed for a broad audience of clinical researchers. Accordingly, some sections may not apply to your protocol. Information that may not be applicable for all studies is indicated via blue italics. Disclaimer 3 4 Examples include references to: Investigational Product (IP), the Investigator’s Brochure (IB), or a study pharmacist Safety reporting and adverse events Randomization and unblinding procedures Regulatory authorities Clinical treatment (for a behavioral or study or a registry) Information that may be helpful but does not come directly from ICH or 45 CFR 46 is identified by this icon. Disclaimer (continued) Good Clinical Practice (GCP) Guidelines (ICH-E6) Widely accepted international research standards Title 45 Code of Federal Regulations (CFR) Part 46 Applies to federally funded research Federal regulations to protect human subjects Subpart A: The Common Rule IRB roles and responsibilities/Informed Consent Basis for Research Roles and Responsibilities: Guidelines & Regulations 5 Additional sections of the Code of Federal Regulations apply to clinical trials 21 CFR 11: Electronic Records/Electronic Signatures 21 CFR 50: Protection of Human Subjects 21 CFR 54: Financial Disclosure by Clinical Investigators 21 CFR 56: Institutional Review Boards Additional Guidance FDA Information Sheets Basis for Research Roles and Responsibilities: Guidelines & Regulations (continued) 6 A standard for the design, conduct, performance, monitoring, auditing, recording, analyses, and reporting of clinical trials [studies], that provides assurance that the data and reported results are credible and accurate, and that the rights, integrity, and confidentiality of study subjects are protected. What is GCP? ICH 1.24 7 8 Sets minimum quality standards for the conduct of clinical research Compliance with GCP Ensures that the rights, safety, and well-being of study participants are protected Ensures the integrity of the data submitted for approval Sets standards for a system of mutual accountability among sponsors, regulatory authorities, investigators, and IRBs Why is GCP Important? 9 The regulations and guidelines concerning the establishment of good clinical practice apply to all studies involving human subjects Applies to Interventional studies, including studies without an investigational product Observational studies (specimen collection studies, natural history, etc.) Device studies Realm of GCP in NIDCR Studies 10