To ensure the protection of research participants, the IRB requires investigators to report certain information during the course of the research, either promptly or at the time of continuing review. This may include circumstances where participants experience unanticipated or anticipated problems.
Not sure what should be reported to the IRB? For a complete list of reportable items, see the Investigator Manual (HRP-103) section “What should be reported promptly to the University of Minnesota IRB?”
Resources
The following resources may be helpful:
- Reportable New Information: Quick Guide
High-level, step-by-step guide on how to submit a reportable event for a study.
- How to Withdraw or Discard a Submission: Quick Guide
High-level, step-by-step guide on how to withdraw or discard a submission.
- Corrective and Preventive Action (CAPA) Plan Guide
Guidance and resources for developing a corrective and preventive action plan.
- Common Reasons for Stipulations and Deferrals
List of common reasons for stipulations and deferrals.
We also recommend reviewing the following documents from the HRPP Toolkit Library:
- HRP-103: Investigator Manual
Comprehensive guide of all policies, procedures, and resources related to the conduct of human research at the University of Minnesota.
- HRP-024: New Information
Establishes the process to manage information reported to the IRB to ensure that the rights and welfare of human participants are protected. Specific to issues of: Noncompliance, unanticipated problems involving risks to subjects or others, suspensions of IRB approval, and termination of IRB approval.
- HRP-321: Review of Information Items Worksheet
Used by the convened IRB when reviewing issues of: Serious noncompliance, continuing noncompliance, unanticipated problems involving risks to subjects or others, suspensions of IRB approval, and termination of IRB approval.
RNIs & Monitoring Reports
All written reports from study monitors must be submitted to the Central File for Clinical Trial Monitoring Reports & Self-Assessment form (CMR). The CMR Central File is managed by the HRPP QA (QA) program and the Clinical and Translational Science Institute (CTSI).
If there are findings in a monitoring report that meet the IRB’s definition of promptly reportable events and new information, the investigator must report such events to the IRB as an RNI within five business days of discovery of the event.