Includes ALL of the following books (click for descriptions):

     Book 1A:  Selected Regulations and Guidance for Drug
                       Studies
     Book 3A:  Selected Regulations and Guidance on Protection
                       of Human Subjects
     Book 8:     FDA Drug Approval Process & Clinical Research
                       Dictionary
     Book 13:   ICH Guidelines on Clinical Study Reports &
                       Statistical Reports
     Book 14:   Selected Recently Finalized FDA Guidance
                        Documents

Investigational Sites Series
5-Book Set ($65/set)

Includes ALL of the following books (click for descriptions):

     Book 3A:  Regulations/Guidance on the Protection of
                       Human Subjects
     Book 3B:  Selected Documents on International Ethical
                       Conduct, Federalwide Assurances, & OHRP
                       Compliance in Academic Research
     Book 20:  ORI Introduction to the Responsible Conduct
                       of Research
     Book 22:   FAQs and Guidance on Clinical Research from
                       the OHRP
     Book 5B:  HIPAA Privacy for Researchers: Guidance
                       from the NIH