Good Clinical Practice (GCP) eRegs & Guides - For Your Reference Book 2
Book Details
Author(s)
Food and Drug Administration
Publisher
Biopharma Advantage Consulting L.L.C.
ISBN / ASIN
B007XY9K84
ISBN-13
978B007XY9K84
Sales Rank
#1,995,172
Marketplace
United States 🇺🇸
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Description
E6 Good Clinical Practice
Guidance for Industry Part 11, Electronic Records; Electronic Signatures — Scope and Application
CFR 21-- General Part 11, Electronic Records; Electronic Signatures
21 CFR PART 50 Protection Of Human Subjects
21 CFR Part 54 Financial Disclosure By Clinical Investigators
21 CFR PART 56 Institutional Review Boards
Title 21 PART 312 Investigational New Drug Application
ICH E2A Clinical Safety Data Management: Definitions and Standards for Expedited Reporting
ICH E8 General Considerations For Clinical Trials
Guidance for Industry Part 11, Electronic Records; Electronic Signatures — Scope and Application
CFR 21-- General Part 11, Electronic Records; Electronic Signatures
21 CFR PART 50 Protection Of Human Subjects
21 CFR Part 54 Financial Disclosure By Clinical Investigators
21 CFR PART 56 Institutional Review Boards
Title 21 PART 312 Investigational New Drug Application
ICH E2A Clinical Safety Data Management: Definitions and Standards for Expedited Reporting
ICH E8 General Considerations For Clinical Trials
