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Book 1A:  Selected Regulations & Guidance for Drug Studies

Book 1A: Selected Regulations & Guidance for Drug Studies

$ 15.95

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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.  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?
• 1-249 copies:  $15.95             • 250-499 copies:  $14.95
• 500-749 copies: $13.95          • 750+ copies:  $12.95

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, 2015)

11    Electronic Records/Electronic Signatures (Revised 2015)
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 (Revised 2015)

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

•  ICH Guidelines (US, Step 5)

E6     Good Clinical Practice
E2A   Clinical Safety Data Management: Definitions and Standards for Expedited Reporting
E8     General Considerations for Clinical Trials

•  European Directives on GCP (2001 and 2005) (Revised 2015)

•  Additional FDA Guidance Documents:
       • Selected Drug Development Web Sites (Revised 2015)
       • PhRMA Principles on the Conduct of Clinical Trials (Revised 2015)

       • Oversight of Clinical Investigations — A Risk-Based Approach to 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

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