Book ID Number
Good Clinical Practice Books
for Drug Studies
(click titles for more information)
Total
Number
of Books
Number
with
Custom Covers
Book 1A:
Selected Regulations/Guidance for Drug Studies
Book 1B:
FDA Good Clinical Practice 2008 Reference Guide
Book 3A:
Regulations/Guidance on the Protection of Human Subjects: Clinical Investigator, IRB & Sponsor Responsibilities
Book 8:
Introduction to the Drug Approval Process and Dictionary of Clinical Research Terminology
Book 13:
FDA Guidance on Clinical Study Reports and Statistical Principles for Clinical Trials
Book 14:
Selected Recently-Finalized FDA Guidance Documents
Book 16:
Preambles to Good Clinical Practice Regulations
Book 25:
Laws, Regulations, and Guidance on Pediatric Studies