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

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
  • Policy 801 Reporting Research Events
  • Policy 802 Non-compliance in Human Subjects Research
  • Policy 801 and 802 Guidance for Reporting Research Events and Noncompliance
• 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
  • Policy 801 Reporting Research Events
  • Policy 802 Non-compliance in Human Subjects Research
  • Policy 801 and 802 Guidance for Reporting Research Events and Noncompliance
• 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