Forms and Resources
- Electronic Records/Electronic Signatures 21 CFR 11
- Financial Disclosure by Clinical Investigators 21 CFR 54
- Good Clinical Practice and Clinical Trials
- Institutional Review Boards 21 CFR 56
- Investigational Device Exemption (IDE) 21 CFR 812
- Investigational New Drug (IND) 21 CFR 312
- Premarket Approval of Devices 21 CFR 814
- Protection of Human Subjects 21 CFR 50
- Clinical Investigators, Sponsors, and IRBs: Adverse Event Reporting to IRBs — Improving Human Subject Protection
- Device Advice: Comprehensive Regulatory Assistance
- Information Sheet Guidance for Institutional Review Boards (IRBs), Clinical Investigators, and Sponsors
- Investigational New Drug Applications (INDs) – Determining Whether Human Research Can Be Conducted Without an IND
- Investigator Responsibilities – Protecting the Rights, Safety, and Welfare of Study Subjects
- IRBs, Clinical Investigators, and Sponsors: IRB Responsibilities for Reviewing the Qualifications of Investigators, Adequacy of Research Sites, and the Determination of Whether an IND/IDE is Needed
- Pediatrics
- Selected FDA GCP/Clinical Trial Guidance Documents
- Sponsors, Clinical Investigators, and IRBs: Data Retention When Subjects Withdraw from FDA-Regulated Clinical Trials
- Vaccines, Blood & Biologics: Guidance, Compliance & Regulatory Information
- Biological Materials & Data
- Certificates of Confidentiality – Privacy Protection for Research Subjects
- Federalwide Assurances (FWAs)
- HIPAA: Understanding Health Information Privacy
- Informed Consent
- Investigators
- OHRP Policy & Guidance
- Reviewing and Reporting Unanticipated Problems – Video
- Revised Common Rule Educational Materials
- Reviewing and Reporting Unanticipated Problems Involving Risks to Subjects or Others and Adverse Events
- Vulnerable Populations
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