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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