This spiral-bound, 5" x 7.5" book is a compilation of the FDA regulations and guidance documents that govern the conduct of clinical trials for drug research.  Please note that we have REMOVED the Selected Websites section and ADDED the new April 2023 FDA Guidance of Questions & Answers on Monitoring.  

 It includes such topics as:

• Good Clinical Practice/ Protection of Human Subjects
• IND and NDA filing requirements
• Electronic Records and Signatures
• Monitoring and Reporting Adverse Events

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:  $20.95             • 100-249 copies:  $19.95
• 250-499 copies: $18.95          • 500+ copies:  $17.95

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

•  CFR Title 21:  Food and Drugs (Revised as of April 1, 2023)

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     General Considerations for Clinical Trials

•  European Directives on GCP (2001 and 2005)

•  Additional FDA Guidance Documents:
       • Oversight of Clinical Investigations — A Risk-Based Approach to Monitoring
       • NEW 2023 FDA Questions & Answers on Monitoring      
       • FDA Compliance Program Guidance #7348.810: Sponsors, CROs & Monitors
       • Adverse Event Reporting to IRBs - Improving Human Subject Protection
       • FDA Guidance on Safety Reporting Requirements for INDs and BA/BE Studies   
       • PhRMA Principles on the Conduct of Clinical Trials

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