Human Research Protection Program

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Checklists

Elements of Informed Consent: Review the general requirements of informed consent as found in 45 CFR 46 and 21 CFR 50.

Documentation of the Informed Consent Process: Identify the necessary information to include in the documentation of the informed consent process.

Regulatory File Checklist: Review the general listing of regulatory file content items and those items required for a FDA-governed study.

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