Useful Links

• ICH Guidelines for Good Clinical Practice E6 R (2)
• EMA guidelines for Good Clinical Practice E6 R (2)
• MHRA guidance for the notification of Serious Breaches of GCP or the Trial Protocol
• Japanese Ministerial Ordinance on Good Clinical Practice for Drugs
• Electronic Records; Electronic Signatures (21 CFR Part 11)
• Protection of Human Subjects (Informed Consent) (21 CFR Part 50)
• Financial Disclosure by Clinical Investigators (21 CFR Part 54)
• Institutional Review Boards (21 CFR Part 56)
• Good Laboratory Practice for Nonclinical Laboratory Studies (21 CFR Part 58)
• Investigational New Drug Application (21 CFR Part 312)
• Applications for FDA Approval to Market a New Drug (21 CFR Part 314)
• Bioavailability and Bioequivalence Requirements (21 CFR Part 320)
• WHO Handbook for Good Clinical Practice