Finally, a single book that contains the key documents that cover clinical research in drug and medical device trials for sponsors, investigators/coordinators, and IRBs. At over 750 pages, this spiral-bound, 5.5" x 8" book contains regulations and guidance documents from the FDA and OHRP, covering topics that could previously only be obtained by buying 5 different books. Please see the "Contents" link above for a detailed listing of the documents in this book. Topics covered include:

• Good Clinical Practice/ Protection of Human Subjects
• The FDA Drug Development Process
• Medical Device Regulations
• Federalwide Assurances
• Clinical Research Dictionary
• International Drug Development Web Sites

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:  $45.95
• 101-249 copies:  $39.95 (save up to $500)
• 250-499 copies:  $35.95.95 (save up to $1,000)
• 500-749 copies: $32.95 (save up to $3,000)
• 750+ copies:  $30.95 (save over $3,000)

Custom Cover Prices*?
• 1-10 copies:  unavailable
• Free for over 10 copies

* Based on quantities of a single book title

Table of Contents

DOCUMENTS ON FDA DRUG DEVELOPMENT

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

• CFR Title 21:  Food and Drugs (Revised as of April 1, 2023)
       Parts  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

• 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

• FDA Drug Development Training Documents
       • FDA Drug Development, Approval and Promotion: Selected
          sections from the FDA CDER Handbook
       • FDA Post-Drug-Approval Activites (from the CDER Handbook)

DOCUMENTS ON FDA MEDICAL DEVICE DEVELOPMENT

• CFR Title 21:  Food and Drugs (Revised as of April 1, 2023)
       Parts 807: Establishment, Registration, and Device Listing
                812: Investigational Device Exemptions
                814: Premarket Approval of Medical Devices
 • FDA Guidance on Medical Reporting for Device
    Manufacturers

US DEPARTMENT OF HEALTH & HUMAN SERVICES RESEARCH

• CFR Title 45, Part 46: Protection of Human Subjects

• Federalwide Assurance Documents
       • Terms of the Federalwide Assurance
       • Step-by-Step Instructions for Filing a Federalwide Assurance
       • Application for Filing a Federalwide Assurance
       • OHRP Guidance:  Frequently Asked Questions on the
          Assurance Process
      • OHRP Human Subjects Regulations Decision Charts

INTERNATIONAL ETHICAL PRINCIPLES

• Declaration of Helsinki
• The Belmont Report
• The Nuremberg Code

ADDITIONAL REFERENCE MATERIALS

• Clinical Research Dictionary
• Selected International Web Sites on Drug Development
   (Revised 2023)

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