Good Clinical Practice eRegs & Guides - For Your Reference Book 2
eRegs & Guides · Biopharma Advantage Consulting L.L.C.
Nov 2013 · eRegs And Guides
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About this ebook
Good Clinical Practice eRegs & Guides provides a
reference to key US FDA Guides and regulations via your electronic reader. An
excellent way to access the reference documents on your e-reader. No need to
carry paper books and you can search for key terms.
reference to key US FDA Guides and regulations via your electronic reader. An
excellent way to access the reference documents on your e-reader. No need to
carry paper books and you can search for key terms.
In this issue you will find:
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
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