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?
• 1-99 copies: $19.95 • 100-249 copies: $18.95
• 250-499 copies: $17.95 • 500+ copies: $16.95
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:
• Selected Drug Development Web Sites (Revised 2023)
• PhRMA Principles on the Conduct of Clinical Trials
• 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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