Reportable Events
Unanticipated Problems
- FDA Guidance for Clinical Investigators, Sponsors, and IRBs Adverse Event Reporting to IRBs — Improving Human Subject Protection
- IRB Member Considerations When Evaluating Reported Events as Possible Unanticipated Problems (Narrated PowerPoint)
- Policy 801 Reporting Research Events and Guidance for Reporting Research Events and Noncompliance
There are Currently No Attachments
OHSRP Information
- OHRP Reporting to OHRP: Unanticipated Problems (2020)
- OHRP Unanticipated Problems Involving Risks & Adverse Events Guidance (2007)
- OHRP Videos Related to Incident Reporting and Compliance
- OHSRP Education Series presentation: Reporting Research Events and Non-compliance in Human Subjects Research (Slides and Videocast)
- OHSRP Education Presentation: Two Years Since Release of the “NEW” OHSRP Research Related Event Reporting Policies: How is the IRP Doing? (5/4/2021) Slides and Videocast
Research Related Events and Reporting to the IRB
- FDA Guidance for Clinical Investigators, Sponsors, and IRBs Adverse Event Reporting to IRBs — Improving Human Subject Protection
- Guidance for Reporting Research Events and Noncompliance (OHSRP)
- IRB Member Considerations When Evaluating Reported Events as Possible Unanticipated Problems (Narrated PowerPoint)
- PII/PHI Breaches: also see information in index section “Non-compliance”)
- Policies
- Reportable Event Flow Process Diagram
- OHRP Videos Related to Incident Reporting and Compliance
- OHSRP Education Series presentation: Reporting Research Events and Non-compliance in Human Subjects Research (5/20/2019) Slides and Videocast
- OHSRP Education Presentation: Two Years Since Release of the “NEW” OHSRP Research Related Event Reporting Policies: How is the IRP Doing? (5/4/2021) Slides and Videocast
Noncompliance
- Guidance for Reporting Research Events and Noncompliance
- PII/PHI Breaches
- Incident Response Team Portal (for reporting possible/definite breaches)
- Privacy Coordinators list by IC
- Privacy Incidents and Breach Response (NIH webpage)
- Policies
- OHRP Videos Related to Incident Reporting and Compliance
- OHSRP Education Presentation: Two Years Since Release of the “NEW” OHSRP Research Related Event Reporting Policies: How is the IRP Doing? (5/4/2021) Slides and Videocast
- Reportable Event Flow Process Diagram
- Research Compliance Review Committee: See Policy 802, (definition in section 4.7 and responsibilities in section 5.5)
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
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