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Good Clinical Practice Handbook
Good Clinical Practice Handbook
SKU:978-1-933734-57-6
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GCP Handbook - 21 CFR Parts 11, 50, 54, 56, 312, 314, ICH E2A, E6(R3)
- 11 - Electronic Records; Electronic Signatures
- 50 - Protection of Human Subjects
- 54 - Financial Disclosure by Clinical Investigators
- 56 - Institutional Review Boards
- 312 - Investigational New Drug Application
- 314 - Applications for FDA Approval to Market a New Drug
- ICH E2A - Clinical Safety Data Management
- ICH E6(R3) - Guideline for Good Clinical Practice
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21CFR11-50-54-56-312-314-ICHE2-E6-C-251225
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