This spiral-bound, 5" x 7.5" book consists of US FDA GCP regulations, including all of 21 CFR Part 314 (NDAs), ICH Guidelines,  the new EU Clinical Trials Regulation, as well as the EU GCP Directive and the repealed EU Clinical Trials Directive.

Who Uses this Book and How?
• Clinical Research staff, as job aids
• Training departments, as training handouts
• Human Resources, as part of new-employee orientation
• Legal/Regulatory/QA staff, for company-wide distribution

What's the Price?
• 1-99 copies:  $22.95             • 100-249 copies:  $21.95
• 250-499 copies: $20.95          • 500+ copies:  $19.95

Custom Cover Prices*?
• 1-24 copies:  unavailable             • 25-100 copies:  $2.00/book
• 100-249 copies: $1.00/book        • 250+ copies:  No charge

* Based on quantities of a single book title

Contents

•  EU Regulation No. 536/2014 on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC

•  CFR Title 21:  Food and Drugs (Revised as of April 1, 2024)

11    Electronic Records/Electronic Signatures 
50    Protection of Human Subjects
54    Financial Disclosure
56    Institutional Review Boards 
312  Investigational New Drug Application
314  Applications for FDA Approval to Market a New Drug 

•  Index to 21 CFR Parts 11, 50, 54, 56, 312, 314

•  ICH Guidelines (US, Step 5)

E6(R2)  Good Clinical Practice (Includes R2 Addendum)
E2A   Clinical Safety Data Management: Definitions and Standards for Expedited Reporting
E8(R1)  General Considerations for Clinical Trials

•  European Directives on GCP (2001 and 2005)

Click here to see an enlarged pdf cover