|TYPE OF EVENT OR INFORMATION
|REPORTING MECHANISM AND TIMEFRAME for INFORMATION AND OCCURRENCES (NON-AE)
Report as an ORIO within 7 CALENDAR DAYS of becoming aware of the event or information
Report as part of SCHEDULED CONTINUING REVIEW (SCR)
NOTE: These events or reports do not require a separate ORIO submission. They should be uploaded into field 4.1 of the Scheduled Continuing Review (SCR) application, and discussed within the SCR field 1.2.
(see Examples heading below)
(whenever possible, report planned protocol deviations ahead of the event)
- Major protocol deviations that may adversely impact safety of participants, or impact integrity/validity of the data (e.g. missed or out of window labs, procedures, or visits that would have been conducted for safety purposes)
- Minor protocol deviations as part of a pattern and/or suggesting a systemic problem in study conduct that potentially places subjects or others at a greater risk of harm than was previously known or recognized
- Informed consent process deviations for the purpose of accommodating a specific participant's special communication needs
Upload an aggregate report into SCR submission
Minor protocol deviations that do not impact safety of participants or impact integrity/validity of the data. For example:
- schedule deviations (out of window), except when the visit or test would assess participant safety
- minor informed consent deviations (wrong version date, wrong expiration date, as long as the content is the same)
The aggregate deviation report should contain the same information as it the events were reported individually, such as:
- date of occurrence
- subject ID (do not include direct identifiers)
- adequate description of the event for IRBMED to determine the seriousness of the event
- whether the sponsor was notified of the event
- (if PI initiated study) effects to participant and/or data safety
|Report(s) to or from oversight entity
- DSMB/DSMC reports with findings that yield implications for the conduct of the study (issues of safety, data validity or regulatory compliance)
- Routine monitoring reports with implications for the conduct of the study (issues of safety, data validity or regulatory compliance)
This includes reports from sponsor or CRO monitoring visits, and internal monitoring committees such as ORCR, MICHR, and QARC
- Reports of internal or external audits
- Reports on Drug or Device recalls or safety notices from the sponsor
- Study holds or suspensions that are not built into the study design
- Study completed or enrollment closed/completed notifications with safety or regulatory concerns
- Any other reports from sponsor, oversight entity or other sources with safety or regulatory concerns
Upload these reports individually into SCR submission or separately as required by the Sponsor's protocol or contract.
- DSMB/DSMC (formally charged oversight entity) reports without any action items or safety issues
(Note: Letters of explanation or clarification, and other requests for additional information from a DSMB/DSMC, are mostly interpreted by IRBMED to imply the study may “Continue without Modification” and can be reported at the time of Continuing Review.)
- FDA annual reports
- Temporary Hold notifications as indicated in the approved protocol and limited to activities not impacting subject safety, such as routine interim data analyses
- Study completed or enrollment closed/completed notifications without safety or regulatory concerns
- ORCR monitoring reports
- For U-M held IND or IDE: All monitoring reports (i.e. MICHR reports), per HRPP OM Part 8.VII.B
NOT REQUIRED TO SUBMIT: Routine monitoring reports (Interim monitoring reports, or other) without issues impacting safely, data validity, or regulatory compliance. These must be retained by the study team and available upon request.
This includes reports from sponsor or CRO monitoring visits, and internal monitoring committees such as QARC. (Exception for UM held IND/IDE: see above.)
|Notification of Audit/Inspection/Inquiry
- For Federal audits (e.g., FDA, NIH, OHRP), contact the Office of Regulatory Affairs and IRBMED by phone immediately upon notification of audit. Submit “Report(s) to or from oversight entity” ORIO to IRBMED once the audit has been conducted
- All other audits (e.g., by Sponsor or an external IRB), submit ORIO via eResearch notifying IRBMED when the audit will occur and the anticipated length.
- Internal Monitoring Committee (ORCR, MICHR) reports may need to be submitted as soon as they are received.
|Report of lapse in IRB approval
- Federally sponsored or FDA regulated studies irrespective of study activity during lapse in approval (see exceptions below**)
- Non-federally sponsored and non-FDA regulated studies with any study activity during lapse in approval
Non-federally sponsored and non-FDA regulated studies with a lapse in IRB approval and with no study activities – post-correspondence or indicate in the SCR application question 1.2 (free-text field on study progress) that no study activity occurred during the lapse in approval.
- Accidents/Incidents involving subjects/data/specimens/facilities
- Breach of confidentiality -- see examples heading below for further discussion
NOTE: Additional reporting beyond IRB is also required per U-M SPG 601.25: if PHI is involved, contact the Compliance Office; if research data are involved, notify UMOR.
Complaints related to participant safety, study conduct, supporting documents content or unresolved participant payment—
If any complaint cannot be readily resolved by the study team and requires numerous and/or detailed steps towards resolution, submit the plan to IRBMED for review and approval.
When in doubt
If you are not sure about your reporting obligation for a specific subject complaint, please reach out to the IRBMED office for assistance (734-763-4768; email@example.com).
Complaints not related to subject safety, study conduct, or supporting document content, e.g.:
- A participant is upset about a delay in payment or with making an appointment, but it is readily resolved by the study team and to the participant’s satisfaction
The SCR should include a summary or tabulation of complaints not previously reported to the IRBMED, along with their resolution.
The study closure (termination) report should include a summary of complaints not previously reported, and a summary of the number of participant complaints over the course of the study, a description of those complaints, and their resolution.
See Prisoners in Research guidance page
For studies, not previously approved by IRBMED to enroll prisoners and there is:
- Unintentional enrollment of a prisoner or
- Intent to continue participation of a previously enrolled subject who becomes incarcerated
It is preferred that withdrawals are not routinely reported individually. Only withdrawals for the following reasons should be reported individually:
- Safety reasons
- Participant Complaint
- Atypical/unusual reason
Report Withdrawals section 02-3 of the SCR application
Withdrawal of a participant due to routine reasons such as:
- PI discretion
- Met the criteria outlined in the Protocol for Withdrawal
- Time restrictions
- Not wanting to complete study procedures
|Pertinent publication/public announcement
- Urgent information affecting the risk/benefit ratio of the study when notification of IRB cannot wait for an amendment to be submitted (i.e., memo regarding newly identified risk, but the revised protocol/IB are not ready to be published yet)
- Information affecting subjects willingness to participate in the research
- Newsletters that will be sent to enrolled subjects that need more timely review than annually
|Not Regulated activities including QA/QI projects
|Other Miscellaneous Information
- If there is any event or information that is not identified above or identified but needs immediate IRBMED attention, contact the IRBMED office for guidance.
- IRBMED must review - in advance - any communication provided to research subjects.