This spiral-bound, 3" x 5" book contains the key US regulations governing the conduct of clinical studies for FDA approval. It also includes a detailed subject index for quick and convenient access to information. NOTE: It does not contain 21 CFR Part 314 or any ICH guidelines or FDA guidance documents. Users requiring ICH guidelines and FDA guidance documents should browse through the other books listed under the heading, "Clinical Research and Good Clinical Practice" on this website.
Books are pocket-sized with a tiny coil binding for easy transportability. Sections have printed section dividers for easy navigation between topics.
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: $10.95 • 250-499 copies: $9.95
• 500-749 copies: $8.95 • 750+ copies: $7.95
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
54, 56, & 312
• CFR Title 21: Food and Drugs (Revised as of April 1, 2019)
Parts 11 Electronic Records/Electronic Signatures
50 Protection of Human Subjects
54 Financial Disclosure
56 Institutional Review Boards
312 Investigational New Drug Application
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