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Research > Clinical Research > FDA Guidances

FDA Guidances

Below are the common FDA Guidances that relate to human subjects research and their direct links.

Investigator Guidances

Guidance for Sponsors, Clinical Investigators and IRBs Frequently Asked Questions — Statement of Investigator (Form FDA 1572)
Guidance for Industry Investigator Responsibilities — Protecting the Rights, Safety, and Welfare of Study Subjects
Guidance for Industry Financial Disclosure by Clinical Investigators
Guidance For IRBs, Clinical Investigators and Sponsors FDA Inspections of Clinical Investigators
Guidance for Institutional Review Boards, Clinical Investigators and Sponsors Clinical Investigator Administrative Actions — Disqualification
Guidance for Industry and Clinical Investigators The Use of Clinical Holds Following Clinical Investigator Misconduct
HHS Investigator Responsibilities: FAQs
Guidance for Industry Information Program on Clinical Trials for Serious or Life-Threatening Diseases and Conditions

Study Management

Safety Reporting Requirements for INDs and BA/BE Studies

Safety Reporting Requirements for INDs and BA/BE Studies- Small Entity Compliance Guide

Electronic Data

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