This spiral-bound, 5" x 7.5" book is a compilation of the FDA Information Sheets, selected government regulations, and other helpful documents that address the protection of human subjects in research.  It includes such topics as:

• Informed Consent
• The Common Rule (45 CFR Part 46)/ Protection of Human Subjects
• Reviewing and Reporting Unanticipated Problems
• The HIPAA Privacy Rule in Research
• Recruiting Study Subjects

Who Uses this Book?
• Clinical research center staff
• Clinical research monitors (CRAs)
• Investigators, study coordinators, IRB members
• Sponsor training departments

What's the Price?
• 1-249 copies:  $22.95            • 250-499 copies:  $21.95
• 500-749 copies: $20.95        • 750+ copies:  $19.95

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

Table of Contents

•  FDA INFORMATION SHEETS:  Guidance for Institutional Review Boards, Clinical Investigators and Sponsors

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

•  FDA Bioresearch Monitoring Compliance Program Manual

Program #7348.809 - Institutional Review Boards 
Program #7348.811 - Clinical Investigators

•  FDA Guidance:  Investigator Responsibilities – Protecting the Rights, Safety, and Welfare of Study Subjects

•  Guidance on HIPAA Privacy and Research (Includes Frequently Asked Questions and Answers

•  NEW! FDA Guidance for Informed Consent (August 2023) 

•  CFR Title 45:  Public Welfare 

Parts
46    Protection of Human Subjects (As of April 1, 2024)
164   HIPAA Privacy: Selected Sections on Research

•  CFR Title 21:  Food and Drugs (As of April 1, 2024)

Parts 
11    Electronic Records/Electronic Signatures
50    Protection of Human Subjects
54    Financial Disclosure
56    Institutional Review Boards

•  OHRP Guidance on Reviewing and Reporting Unanticipated Problems Involving Risks to Subjects or Others and Adverse Events

•  IRB Responsibilities for Reviewing the Qualifications of Investigators, Adequacy of Research Sites, and the Determination of Whether an IND/IDE is Needed

* Need to add or remove a section?
  Give us a call:  866-427-4843

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