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FDA Code of Federal Regulations Mini-Handbooks!
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CFR Rule Changes by GXPNews

GCP - Good Clinical Practice Handbooks
Standard GCP - Good Clinical Practice Handbook

  • 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 - Guideline for Good Clinical Practice


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Parts 50, 54 and 56 GCP Drug Approval Handbook
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Parts 312, 314 and 511 - Human and Animal Drug Approval
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Part 50 - Protection of Human Subjects
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Part 54 - Financial Disclosure by Clinical Investigators
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Part 56 - Institutional Review Boards
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Part 312 - Investigational New Drug Application
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Part 314 - Applications for FDA Approval to Market a New Drug
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Part 316 - Orphan Drugs
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Basic EU GMPs Chapter 1 - 9
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5 Book Minimum! Basic EU GMPs Chapter 1 through 9 with Glossary
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