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.
Medical College of Wisconsin
8701 Watertown Plank Road
Milwaukee, WI 53226
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