Guidance

Other Reportable Information or Occurrence (ORIO)

IRBMED
Jun 11, 2018 10:00 am
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Investigators sometimes receive information that has a direct impact on a research study. This information is reportable to the IRBMED. Frequently this information falls within the Adverse Event Reporting context, or it is reported to IRBMED in conjunction with a protocol, investigatorship, or informed consent amendment. When those contexts don't apply, information should be reported as an ORIO in accordance with the guidelines below.

For information about other types of required reporting, see the Adverse Events (AEs), Other Reportable Information and Occurrences (ORIOs), and Other Required Reporting page.

**When notified of an Audit by a Federal Regulatory Agency (i.e., FDA, NIH, OHRP etc.), immediately call the Office of Regulatory Affairs (647-1576) and IRBMED (763‑4768) to inform each unit of the date of inspection.  See below (Notification of Audit/Inspection/Inquiry).

** If an ORIO indicates notification of research subjects is necessary, IRBMED must review and approve materials prior to utilization.

Click on the headings below to expand.

  • Reporting timetable for approved studies subject to annual Continuing Review (CR)

    “Continuing Review” (CR) consists of annual submission by study team of a report on the study’s status and continued plans, for renewed review and approval by the IRB. See IRBMED FAQ heading “Ongoing Review.” If an approved study space shows an Expiration Date, the study requires CR.

    The following chart is for studies requiring annual Continuing Review that follow IRBMED standard ORIO reporting.

    IRBMED ORIO Reporting Guidance

    Click here for PDF of IRBMED ORIO Reporting Guidance.

    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)*

    *NEW: These events or reports should be uploaded as supporting documents into the SCR application, and/or discussed in the SCR application. They do not require a separate ORIO submission.
    Protocol Deviations
    • Major protocol deviations that may adversely impact safety of participants, or impact integrity/validity of the data
    • 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

    Upload a spreadsheet with aggregate reports into SCR application- Section 4: Additional Supporting Documents

    • Minor protocol deviations that do not impact safety of participants or impact integrity/validity of the data – for example, schedule deviations, minor informed consent deviations (wrong version date, wrong expiration date, as long as the content is same)
    Report(s) to or from oversight entity                 

     
    • Monitoring reports (DSMB or other) with issues of safety or data validity at U-M
    • Reports of internal or external audits
    • Reports on Drug or Device recalls 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 reports from sponsor or oversight entity with safety or regulatory concerns
    		 Upload these reports individually into SCR application-Section 4: Additional Supporting Documents                
    • Routine monitoring reports (DSMB or other) without safety issues  NOTE:  may be submitted to IRBMED by separate ORIO if required by the protocol or contract
    • Reports related to routine monitoring/periodic visit without any action items or safety concerns
    • IND/IDE 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
    Report of lapse in IRB approval
    • Federally sponsored or FDA regulated studies irrespective of study activity during lapse in approval
    • 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.
    Accident/Incident
    • Accidents/Incidents involving subjects/data/specimens/facilities (e.g., breach of confidentiality).  Also, if PHI is involved, contact the Compliance Office; if research data are involved, notify UMOR.

    N/A
    Complaint
    • Complaints related to subject safety or study conduct or supporting documents content.

     

    N/A
    Subject Incarceration 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

    N/A
    Subject Withdrawal

    Withdrawal due to safety reasons
    • Withdrawal of a subject due to PI discretion or other reasons, such as meeting protocol stopping rules

    (NOTE: Include in Withdrawals section 02-3 of the SCR application)
    Pertinent publication/public announcement
    • Information affecting the risk/benefit ratio of the study
    • Information affecting subjects willingness to participate in the research

    N/A

    Notification of Audit/Inspection/ Inquiry
    • For Federal audits (e.g., FDA, NIH, OHRP), contact the Office of Regulatory Affairs (ORA) 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
    		 N/A
    Not Regulated activities including QA/QI projects
    • Contact the IRB

    N/A
    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.

     

     

    Posted 3/6/2017
    Updated 6/11/2018

  • STUDIES NOT REQUIRING CONTINUING REVIEW (CR)

    Per 2018 Flexibility Initiative, some ongoing studies no longer require annual Continuing Review (CR). The study workspace indicates “No Continuing Review Required for this application” when applicable. Studies not requiring CR should report only potential Unanticipated Problems (UaPs or UPIRSOs) that come to the attention of the study team. Routine ORIOs need not be reported. This also applies to studies that previously had an approved study-specific reporting plan.

    Unanticipated Problems meet all of the following criteria:

    1. Unexpected (in terms of nature, severity, or frequency);
    2. Related or possibly related to participation in the research; and
    3. Suggests that the research places subjects or others at a greater risk of harm than was previously known or recognized.

    See the Unanticipated Problems Involving Risks to Subjects or Others page and U-M HRPP Operations Manual Part 12.III.B.1.a for more details.

    Similarly, studies that have been Terminated, studies with Exempt determination, and projects with Not Regulated determination should report only potential Unanticipated Problems (UaPs or UPIRSOs).

Units: Institutional Review Boards (IRBMED)
Topic: Adverse Events & Other Reportable Information and Occurrences Application Types eResearch Regulatory Management (eRRM) Investigator & Study Team Responsibilities
Questions?

Contact us at irbmed@umich.edu or 734-763-4768 / (Fax 734-763-1234)
2800 Plymouth Road, Building 520, Room 3214, Ann Arbor, MI 48109-2800

A list of IRBMED staff is available in the Personnel Directory, or view the list of Regulatory Teams.

Edited By: bpsea@umich.edu
Last Updated: October 8, 2018 3:00 PM