Links are provided to pertinent regulatory resources such as the Office of Human Subjects Protection, Food and Drug Administration, and ICH E6 Good Clinical Practice Efficacy Guidelines.”
Institutional Review Board (21 CFR 56)
Electronic Records and Signatures (21 CFR11)
Financial Disclosures (21 CFR 54)
Investigational New Drugs (IND)(21 CFR 312)
Investigational Device Exemption (IDE)(21 CFR 812)
