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US FDA Title 21 CFR Parts
- Part 11 Electronic Records
- Part 50
Protection of human subjects
- Part 54
Financial disclosure by clinical investigators
- Part 56
Institutional Review Boards
- Part 312 Investigational New Drug Application
- Part 314 Application to the FDA to Market a New Drug
International Conference on Harmonisation Regulations
- ICH E2A Good Clinical Practice
- ICH E6 (R1) Clinical Safety Data Management
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