Book 3A: 2026 Selected Regulations and Guidance on Protection of Human Subjects: Clinical Investigator, IRB & Sponsor ResponsibilitiesDescription Contents Cover 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

Subpart D: Additional Safeguards for

• Recruiting Study Subjects

• Privacy Boards

1252/2014 with Regard to Principles

• The timeline may be further pushed back based on resource needs in support of other Medidata-related priorities

• Chapter 8: Complaints and Product Recall

•   FDA Guidance: Qualifying for Pediatric Exclusivity Under Section 505A of the Federal Food

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

• Amendment of Certain Requirements for Finished

Waiver of IRB Requirements

Adequacy of Research Sites

•   ICH Guidelines