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.
• 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 (Revised 2019)
• CFR Title 45: Public Welfare
46 Protection of Human Subjects (As of April 1, 2019)
164 HIPAA Privacy: Selected Sections on Research
• CFR Title 21: Food and Drugs (As of April 1, 2019)
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?
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