GCP Useful Links

Bioethics
Clinical Trial Regulatory Information Resources
eConsent and eSignatures
GCP Ethical Standards and Guidelines

 

UK - Useful Links

 

 

 

USA - Useful Links

 

  • eCRF – Electronic Code of Federal Regulations
  • 21 CFR 11 – Electronic Reports; Electronic Signstures
  • 21 CFR 50 – Protection of Human Subjects: Informed Consent
  • 21 CFR 54 – Financial Disclosure by Clinical Investigators
  • 21 CFR 56 – Institutional Review Boards
  • 21 CFR 312 – Investigational New Drug Application
  • 21 CFR 314 – Applications for FDA Approval to Market a New Drug