Book No.
Discounted Book Sets
(click on titles for descriptions)

Total
Number
of
Sets

Number with
Custom Covers
Set #1: Good Clinical Practice for Drug Studies
5 -Book Set ($65/set)

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

     
Set #2: Investigational Site Series
5 -Book Set ($65/set)

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

    Book 3A:  Selected Regulations and Guidance on 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