Book No.
All 25+ Book Titles
(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
1SP:
NEW! SPANISH LANGUAGE 2011 Selected FDA Regulations and ICH Guidelines for Clinical Studies for US Drug Approval
2:
Selected Regulations/Guidance for Medical Device Studies
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
4:
Selected Regulations/Guidance on Good Manufacturing Practice
5A:
Administrative Simplification Provisions of HIPAA: The Act, Regulations and DHHS (OCR) Guidance
5B:
HIPAA Privacy for Researchers: Guidance from the NIH
6:
The EU Directives on GCP, Selected EU Guidances, and the Declaration of Helsinki
7:
Selected Laws/Regulations/Guidance on Drug Marketing, Advertising, and Labeling
8:
Introduction to the Drug Approval Process and Dictionary of Clinical Research Terminology
9:
Regulations/Guidance on Good Laboratory Practice and Nonclinical Research
10:
Selected Regulations/Guidance on Biologics, Blood Products and Good Tissue Practice
11:
Selected Documents on Conducting Clinical Research in Canada
12:
Selected Regulations/Guidance on GCP in India
13:
FDA Guidance on Clinical Study Reports and Statistical Principles for Clinical Trials
14:
Selected Recently-Finalized FDA Guidance Documents
15:
Volunteering for a Clinical Trial: A Q&A Guide
16:
Preambles to Good Clinical Practice Regulations
17:
Preambles to Good Manufacturing Practice Regulations
18:
SPANISH LANGUAGE ICH Guideline for GCP & FDA CDER Handbook on Drug Approval
19:
Preambles to Good Laboratory Practice Regulations
20:
ORI Introduction to the Responsible Conduct of Research
21:
Pharmaceutical Administration, Regulations, and Drug Development in Japan
22:
Frequently Asked Questions and Guidance on Clinical Research from the OHRP
23:
Part 11 & Drug Development: Regulation, Preamble & FDA Guidance on Electronic Records & Electronic Signatures
24:
European Union Guidelines on Pharmacovigilance for Medicinal Products for Human Use
25:
Laws, Regulations, and Guidance on Pediatric Studies
26:
People's Republic of China: Selected Laws and Regulations on Drug Research & Good Manufacturing Practice