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 Regulations 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?
• 1-99 copies: $24.95 • 100-249 copies: $23.95
• 250-499 copies: $22.95 • 500+ copies: $21.95
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 2024)
11 Electronic Records/Electronic Signatures
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
• Selected FDA Information Sheets, Guidance for IRBs, Clinical Investigators and Sponsors
- FAQs on IRBs and informed consent
- Cooperative Research
- Non-Local IRB Review
- Sponsor-Investigator Relationship
- Charging for Investigational Products
- Recruiting Study Subjects
- Payment and Reimbursement to Research Subjects
- Screening Tests Prior to Enrollment
- Off-Label Use of Marketed Products
- Emergency Use of Investigational Products
- Treatment Use of Investigational Drugs
- Waiver of IRB Requirements
- Drug Study Designs
- Evaluation of Gender Differences
- FAQs on Form FDA 1572
- FDA IRB Inspections and Clinical Investigators
- Clinical Investigator Disqualification
• NEW Informed Consent Guidance (August 2023)
• 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(R1) General Considerations for Clinical Trials
• Additional FDA Guidance Documents:
• Oversight of Clinical Investigations — A Risk-Based Approach to Monitoring
• Qs & As on Monitoring
• FDA Compliance Program 7348.810: Sponsors, CROs & Monitors
• Adverse Event Reporting to IRBs - Improving Human Subject Protection
• Safety Reporting Requirements for INDs and BA/BE Studies
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