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Book 1B:  FDA Good Clinical Practice Guide

Book 1B: FDA Good Clinical Practice Guide

$ 15.95

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This spiral-bound, 5" x 7.5" book is a compilation of the FDA Good Clinical Practice regulations (21 CFR Parts 11, 50, 54, 56, and 312) and ICH Guidelines (E6, E2A, and E8), as well as the FDA Information Sheets and other guidance documents that govern the conduct of clinical trials for drug research.  Please note that this book does NOT contain the sections of 21 CFR
Part 314 on New Drug Applications (NDAs).  21 CFR Part 314 is contained in its entirety in Book 1A, Selected Regulatons and Guidance for Drug Studies.

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

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

•  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  Sections 314.80, 314.81: Post-Marketing Reporting
Section 314.126: Adequate and Well-Controlled Studies (Revised 2015)

•  FDA INFORMATION SHEETS:  Guidance for IRBs, Clinical Investigators and Sponsors (Revised 2015)

Includes guidance on Informed Consent, Subject Recruitment, Payments to Study Subjects, Subject Screening Tests, and Treatment Use of Investigational Drugs.

•  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

• Additional FDA Guidance Documents:

• Selected Drug Development Web Sites (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
• Safety Reporting Requirements for INDs and BA/BE Studies

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

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