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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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