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Book 3A:  Selected Regulations and Guidance on Protection of Human Subjects:  Clinical Investigator, IRB & Sponsor Responsibilities

Book 3A: Selected Regulations and Guidance on Protection of Human Subjects: Clinical Investigator, IRB & Sponsor Responsibilities

$ 15.95

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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:  $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

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. (Revised 2015)

•  IRB Continuing Review after Clinical Investigation Approval

•  FDA Bioresearch Monitoring Compliance Program Manual

Program #7348.809 - Institutional Review Boards (Revised 2015)
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 (Revised 2015)

•  CFR Title 45:  Public Welfare (As of April 1, 2015)

46    Protection of Human Subjects
164   HIPAA Privacy: Selected Sections on Research

•  CFR Title 21:  Food and Drugs (As of April 1, 2015)

11    Electronic Records/Electronic Signatures (Revised 2015)
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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