Elements of Informed Consent: Review the general listing of regulatory file content items and those items required for a FDA-governed study.
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.
Research Subject Study Records (in progress): Identify items and documentation to include in the research subject study file.