Guidance

External Adverse Event (AE) Reporting

IRBMED
Aug 14, 2015 12:30 pm
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This page explains the required reporting for 'external' AEs. These are events that are under the direct oversight of non-UM investigators and non-UM IRBs, events about which the UM investigator receives a report, usually from the study sponsor or oversight entity.

  • The UM investigator is required to submit the report to the IRB only when one of following criteria applies:
  • The event or information in the report constitutes an 'unanticipated problem'*
  • The report requires a change in the research

The report is an analysis, safety, or statistical report from an oversight entity (e.g. FDA letter, Periodic Sponsor Report of all AEs, Data and Safety Monitoring Board Report)

The information below explains the time frames for reporting and which forms should be used (based on the nature of the report).

  • *Unanticipated Problems Involving Risks to Subjects or Others—Assessment Criteria
    1. The nature, severity, or frequency of the event(s) or information was NOT expected, given descriptions in the study documents or the characteristics of the subject population being studied.
    2. There is a reasonable possibility that the procedures involved in the research caused or are linked in a significant way to the problem.
    3. The event(s) or information suggests that the research places subjects or others at a greater risk of harm than was previously known or recognized (including physical, psychological, economic, or social harm).

  • Instructions for Reporting External Adverse Events to the IRB

    Follow this for more information about making an 'unanticipated problem' assessment

    Instructions for Reporting External Adverse Events to the IRB

    All reference to 'days' herein refers to 'calendar days' rather than 'working days.'
    Report Type Required Timeframe Required Information

    Unanticipated Problem Involving Risks to Subjects or Others: A report of any harm or an analysis of drug or study AE trends that suggests the research places subjects or others at a greater risk of harm than was previously known or recognized and/or is significant to the rights and welfare of human subjects in the study.

    The judgment that an event, series of events, or analysis is an 'unanticipated problem' may be made by the sponsor, DSMB/DSC, other oversight entity, or the UM investigator.

    		 Within 7 days of receipt of the report if serious and related
    Within 14 days of receipt of the report if non-serious and related

    1. The phrase 'Unanticipated Problem' or the acronym 'UaP' must appear in the submission title (eResearch 1.1) [IRBMED Legacy 2.3 and 6.4].

    2. An explanation of how the event is unanticipated.

    3. An explanation of how the event is a problem for the study.

    4. A copy of the report from the external source.
    Unanticipated Adverse Device Effect (UADE:) Reports from sponsors of any serious adverse effect on the health or safety of subjects, or any life-threatening problem or death caused by, or associated with, a device, if that problem or death was not previously identified in nature, severity, or degree of incidence in the investigational plan (21 CFR 812). Within 7 days of receipt of the report

    1. The phrase 'Unanticipated Adverse Device Effect' or the acronym 'UADE' must appear in the submission title (eResearch 1.1) [IRBMED Legacy 2.3 and 6.4].

    2. A copy of the sponsor's report. 
    Medwatch or other Report of a Single Adverse Event that is not judged an 'unanticipated problem' (see above) but requires a change in the research (e.g. the protocol, consent, risk level, investigator's brochure). PI initiated study: Within 7 days of notification of the event      

    Sponsored or Cooperative-group Study: Within 7 days of notification of the requirement for the change

    1. Justification for why the event necessitates the change(s).

    2. Notification of any changes made prior to IRB approval to eliminate apparent immediate hazards to subject(s) or others.

    3. A copy of the report from the external source.
    DSMB/DSC Report (may include external and UM events) Within 7 days of receipt if a change to the research is required OR the risk/ benefit ratio of the study or subjects' willingness to participate is affected.      

    Otherwise at SCR

    1. Investigator's response.

    2. A copy of the report from the external source.
    Periodic Summaries or Analyses of study-wide adverse events Within 7 days of receipt if a change to the research is required OR the risk/ benefit ratio of the study or subjects' willingness to participate is affected.      

    Otherwise at SCR

    1. Investigator's response.

    2. A copy of the report.
    Medwatch or other Report of a Single** Adverse Event where both of the following are true:      
    • Event is not deemed an unanticipated problem
    • Event does not require a change in the research (e.g. the protocol, consent, investigator's brochure).
    		 An IRB submission is not required but may be accepted with the investigator's justification for submitting the report

    1. Investigator's justification or reasons for submitting a report that is not required.

    2. A copy of the report
    Follow-up Report on a Single Adverse Event deemed an unanticipated problem       
    • Unanticipated problem judgment may have been made with the initial report or may be a new assessment based upon new information
    		 Within 7 days of receipt of the report if serious and related
    Within 14 days of receipt of the report if non-serious and related

    1. The phrase 'Unanticipated Problem' or the acronym 'UaP' must appear in the submission title (eResearch 1.1) [IRBMED Legacy 2.3 and 6.4].

    2. An explanation of how the event is unanticipated noting if this assessment is new, and if so, why.

    3. An explanation of how the event is a problem for the study.

    4. A copy of the report from the external source
    Follow-up Report on a Single Adverse Event not deemed an unanticipated problem An IRB submission is not required but may be accepted with the investigator's justification for submitting the report

    1. Investigator's justification or reasons for submitting a report that is not required.

    2. A copy of the report 

    ** Sometimes a sponsor will send multiple 'single' AE reports to an investigator in a batch. These are still considered the type of reports for which a submission to the IRB is not required (unless there is a UaP or a change is required to the research as noted above). What distinguishes a batch of 'single' AEs from the DSMB and/or periodic analyses that must be submitted to the IRB is that the latter include some level of analysis, judgment, or relevant summary that puts the events in a context that provides meaningful information about the study. Examples include but are not limited to the number of AEs in relation to the number of subjects, AEs in relation to the 'n' of the study, an identified series of AEs that indicates a trend.

     

    Posted 9/28/07
    Updated 8/14/2015

Units: Institutional Review Boards (IRBMED)
Topic: Adverse Events & Other Reportable Information and Occurrences Application Types eResearch Regulatory Management (eRRM) Investigator & Study Team Responsibilities
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Edited By: [email protected]
Last Updated: May 31, 2018 1:00 PM

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Statement of Practice: External Adverse Event Reports & Unanticipated ProblemsAdverse Event ReportingAdverse Events (AEs), Other Reportable Information and Occurrences (ORIOs), & Other Required ReportingStudy-Specific Adverse Event (AE) Reporting Plans