Book No.
Good Clinical Practice Books
For Drug Studies
(click on titles for descriptions)
Total
Number
of
Books
Number with
Custom Covers
1A:
Selected Regulations/Guidance for Drug Studies
1B:
FDA Good Clinical Practice 2011 Reference Guide
3A:
Regulations/Guidance on the Protection of Human Subjects: Clinical Investigator, IRB & Sponsor Responsibilities
3B:
Selected Documents on International Ethical Conduct, Federalwide Assurances, & OHRP Compliance in Academic Research
8:
Introduction to the Drug Approval Process and Dictionary of Clinical Research Terminology
13:
FDA Guidance on Clinical Study Reports and Statistical Principles for Clinical Trials
14:
Selected Recently-Finalized FDA Guidance Documents
16:
Preambles to Good Clinical Practice Regulations
25:
Laws, Regulations, and Guidance on Pediatric Studies