Book ID Number
Complete Book List
(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 2:
Selected Regulations/Guidance for Medical Device Studies
Book 3A:
Regulations/Guidance on the Protectionof Human Subjects: Clinical Investigator, IRB & Sponsor Responsibilities
Book 3B:
Selected Documents on International Ethical Conduct, Federalwide Assurances, & OHRP Compliance in Academic Research
Book 4:
Selected Regulations/Guidance on Good Manufacturing Practice
Book 5A:
Administrative Simplification Provisions of HIPAA: The Act, Regulations and DHHS (OCR) Guidance
Book 5B:
HIPAA Privacy for Researchers: Guidance from the NIH
Book 6:
The EU Directives on GCP, Selected EU Guidances, and the Declaration of Helsinki
Book 7:
Selected Laws/Regulations/Guidance on Drug Marketing, Advertising, and Labeling
Book 8:
Introduction to the Drug Approval Process and Dictionary of Clinical Research Terminology
Book 9:
Regulations/Guidance on Good Laboratory Practice and Nonclinical Research
Book 10:
Selected Regulations/Guidance on Biologics, Blood Products and Good Tissue Practice
Book 11:
Selected Documents on Conducting Clinical Research in Canada
Book 12:
Selected Regulations/Guidance on GCP in India
Book 13:
FDA Guidance on Clinical Study Reports and Statistical Principles for Clinical Trials
Book 14:
Selected Recently-Finalized FDA Guidance Documents
Book 15:
Volunteering for a Clinical Trial: A Q&A Guide
Book 16:
Preambles to Good Clinical Practice Regulations
Book 17:
Preambles to Good Manufacturing Practice Regulations
Book 18:
SPANISH LANGUAGE ICH Guideline for GCP & FDA CDER Handbook on Drug Approval
Book 19:
Preambles to Good Laboratory Practice Regulations
Book 20:
ORI Introduction to the Responsible Conduct of Research
Book 21:
Pharmaceutical Administration, Regulations, and Drug Development in Japan
Book 22:
Frequently Asked Questions and Guidance on Clinical Research from the OHRP
Book 23:
Part 11 & Drug Development: Regulation, Preamble & FDA Guidance on Electronic Records & Electronic Signatures
Book 24:
European Union Guidelines on Pharmacovigilance for Medicinal Products for Human Use
Book 25:
Laws, Regulations, and Guidance on Pediatric Studies