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Now Available! Revised APRIL 1, 2024 Books!      Also check out our NEW Book:  Good Clinical Practice Regulations in the US & the EU  (Book 1C)!

Book 3B:  2024 Selected Documents on International Ethical Conduct, Federalwide Assurances, & OHRP Compliance in Academic Research

Book 3B: 2024 Selected Documents on International Ethical Conduct, Federalwide Assurances, & OHRP Compliance in Academic Research

$ 17.95

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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:  $17.95             • 250-499 copies:  $16.95
• 500-749 copies: $15.95          • 750+ copies:  $14.95

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

• 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.

IRB Continuing Review after Clinical Investigation Approval

• 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)
• CFR Title 45:  Public Welfare
       Parts  46    Protection of Human Subjects
                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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