FDA & OHRP Guidance
The FDA provides oversight for clinical trials of investigational drugs, biologic products, and medical devices.
Useful links on the FDA website
Clinical trials involving investigational drugs, biologics, and/or devices are governed by specific FDA regulations. Numerous parties involved in the clinical trials process, including study sponsors, principal investigators, and Institutional Review Boards, are subject to applicable FDA regulations.
- FDA Regulations Related to Good Clinical Practice and Clinical Trials
- Electronic Records; Electronic Signatures 21 CFR 11
- Protection of Human Subjects 21 CFR 50
- Financial Disclosure by Clinical Investigators 21 CFR 54
- Institutional Review Boards 21 CFR 56
- Investigational New Drug Application 21 CFR 312
- Investigational Device Exemptions 21 CFR 812
FDA guidance documents and information sheets
The FDA provides guidance documents that describe the FDA's current thinking about issues related to FDA-regulated clinical trials. In addition, the FDA publishes Information Sheets that provide guidance and recommendations for IRBs, clinical investigators, and sponsors to help them fulfill their responsibilities to protect human subjects who participate in FDA-regulated research.
- Guidance for Industry: Investigator Responsibilities-Protecting the Rights, Safety, and Welfare of Study Subjects
- FDA Guidance for Clinical Investigators, Sponsors, and IRBs: Adverse Event Reporting to IRBs-Improving Human Subject Protection
- Financial Disclosure by Clinical Investigators
- ICH GCP E6--Good Clinical Practice: Consolidated Guidance
Guidance on FDA form completion
Guidance on clinical trial registration on clinicaltrials.gov
- Certification requirements to accompany drug, biologics & device submissions in association with Clinical Trial Registrations
The FDA requires that study sponsors and clinical investigators complete forms specific to the type of study that is being conducted.
- FDA Form 1571 - Information for Sponsor-Investigators Submitting Investigational New Drug Applications
- FDA Form 1572 -Statement of Investigator
- FDA Form 3454 - Certification of Absence of Reportable Financial Interest
- FDA Form 3455 - Financial Disclosure
- FDA Form 3674 - Certificate of Compliance with Requirements of ClinicalTrials.gov Data Bank
Adverse event reporting
Office for human research protection (OHRP) guidance
The OHRP governs clinical trials that are federally-funded.
The OHRP website provides multiple guidance documents, which represent its current thinking on a topic. These documents should be viewed as recommendations.
The OHRP website also has a "Frequently Asked Questions" section that serves as a good reference for IRBs, sponsors, and investigators.
FDA and OHRP compliance findings
OHRP: significant findings and concerns noted in compliance oversight determination letters over the last several years are outlined in the following document.
FDA: The most recent FDA Warning Letters can be accessed on the FDA website
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