Faculty and Staff Resources
ICH (International Conference on Harmonization) — ICH Guidelines
ICH Guidance for Industry: Good Clinical Practice: Consolidated Guidance
Good Clinical Practice in FDA-Regulated Clinical Trials
NIH e-learning course: Good Clinical Practice for Social and Behavioral Research
Code of Federal Regulations: 45 CFR Part 46
Veterans Affairs: Current ORD Policy Documents
FDA Regulations: 21 CFR:
- Part 11 — Electronic Records; Electronic Signatures
- Part 50 — Protection of Human Subjects
- Part 54 — Financial Disclosure by Clinical Investigators
- Part 56 — Institutional Review Boards
- Part 312 — Investigational New Drug Application (IND)
- Part 314 — Applications for FDA Approval to Market a New Drug (NDA)
- Part 600 — Biological Products
- Part 812 — Investigational Device Exemptions
Contact
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Fourth Floor
Baltimore, MD 21201