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GCP - Good Clinical Practice Handbooks
Standard GCP - Good Clinical Practice Handbook
1-933734-57-4

  • 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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Part 50, 54 and 56 GCP Drug Approval Handbook
1-933734-10-8
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Part 312, 314 and 511 - Human and Animal Drug Approval
1-933734-91-4
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Part 50 - Protection of Human Subjects
1-933734-11-6
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Part 54 - Financial Disclosure by Clinical Investigators
1-933734-12-4
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Part 56 - Institutional Review Boards
1-933734-13-2
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Pharmacovigilance for Medical Products Volume 9a
978-1-935131-25-0
Eudralex Pharmacovigilance for Medicinal Products for Human Use Volume 9a 8.5 x 11 Manual September 2008
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Part 312 - Investigational New Drug Application
1-933734-24-8
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Part 314 - Applications for FDA Approval to Market a New Drug
1-933734-25-6
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Part 316 - Orphan Drugs
1-933734-26-4
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Clinical Master Reference Guide
978-1-935131-27-4
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Electronic Systems Master Handbook 1
978-1-935131-15-1
Electronic Systems Master Handbook 1 – Parts 11, Scope and Application, EU Annex 11, EU Annex 15, Electronic Systems Check List, Computerized Systems used in Clinical Investigations.
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