Reportable Events
OHRP and OHSRP Information
- OHRP Reporting to OHRP: Unanticipated Problems (2020)
- OHRP Unanticipated Problems Involving Risks & Adverse Events Guidance (2007)
- OHSRP Education Series presentation: Reporting Research Events and Non-compliance in Human Subjects Research (Slides and Videocast)
Research Related Events and Reporting to the IRB
Noncompliance
- PII/PHI Breaches
- Policies
Unanticipated Problems
IND Safety Reporting-Sponsor vs IRB Reporting Policies
- FDA website: “What is a Serious Adverse Event?”
- FDA Guidance for Clinical Investigators, Sponsors, and IRBs Adverse Event Reporting to IRBs — Improving Human Subject Protection
- OHSRP IND Safety Report Submissions FAQs
- Policy: Policy 500, Research Involving Drugs, Biological, and Nutritional Products, Section E.2.a.VII Sponsor Responsibilities
Overview
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