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Information Sheet Guidances Guidance for Institutional Review Boards, Clinical Investigators, and Sponsors
Background
Through FDA's new Information Sheet Guidance Initiative, these Information Sheets will be revised and updated as needed. The date of the most recent revision is listed next to the title. Learn more about this initiative.
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General
- Frequently Asked Questions
(1998) - IRB Information Sheets--Research and Review (Updated 9/98) -- Cooperative Research
(1998) - Non-Local IRB Review
(1998) - IRB Information Sheets--Research and Review (Updated 9/98)
(1998) - Sponsor-Investigator-IRB Interrelationship
(1998) - Foreign Clinical Studies, Acceptance of
(2001) - Charging for Investigational Products
(1998) - Recruiting Study Subjects
(1998) - Payment to Research Subjects
(1998) - Screening Tests Prior to Study Enrollment
(1998) - Guide to Informed Consent
(1998) - Use of Investigational Products When Subjects Enter a Second Institution
(1998) - IRB Information Sheets - Updated 9/98 -- Exception from Informed Consent For Studies Conducted in Emergency Settings: Regulatory Language and Excerpts from Preamble
(1998) - "Off-Label" and Investigational Use of Marketed Drugs, Biologics and Medical Devices
(1998) - Data Retention When Subjects Withdraw from FDA-Regulated Clinical Trials - Information Sheet (PDF - 399KB)
(2008)
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Drugs and Biologics
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Medical Devices
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FDA Operations
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