Standard GCP - Good Clinical Practice Handbook

Good Clinical Practice (GCP) - Handbook
Starts at $9.90 each. - Updated April 1 - 3.75" x 6.25"
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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