Adverse Event Reporting

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

Note:  Your obligations for reporting internal AEs to sponsors and regulatory agencies are NOT changing; this updated guidance ONLY modifies your reporting obligations for internal AEs to IRBMED. Reporting procedures for external AEs (AEs occurring at sites other than UM) are not changing. The new guidance is not applicable to Study-Specific AE reporting plans.

Please contact IRBMED with any questions you may have regarding this change at 763-4768 or irbmed@med.umich.edu or irbmed@umich.edu.

Internal adverse events are events that involve subjects or others whom the UM investigator is responsible for and/or events for which a UM IRB has direct oversight.

These guidelines apply only to IRBMED reporting. They do not apply to required reporting to other internal or external oversight agencies or departments (e.g., sponsor, FDA, UMHS Compliance Office, DSMB, or Privacy Offices).

OTHER REPORTING TABLES

 

Standard Adverse Event Reporting Guidelines for INTERNAL AEs Occurring at UM

Click here for printable PDF

This chart is for studies following IRBMED standard AE reporting. It may be appropriate for some studies to consider a Study-Specific AE Reporting Plan. See the gray boxes below for information about External AE and UaP reporting.

ae

Definitions:   SCR: Scheduled Continuing Review;    Expected: Has been addressed in one or more of following: Protocol, Investigator Brochure, Package Insert or equivalent, published literature, IRB application, grant application, Data Safety Monitoring Board/Data Safety Committee reports, other documentation, informed consent document (ICD) or characteristics of the study population. Note, per OHRP guidance, event may be “expected” per the natural progression of any underlying disease, disorder, or condition of the subject(s) experiencing the adverse event;    Unexpected: Has not been addressed in one or more of the above examples;    Related: See below;    Unrelated: See Below

References

Defining Relationship to Study Drug/Device/Procedure:  The IRB recognizes that it can be difficult to determine the relationship of event or events to a specific drug/device/procedure when there are several contributing factors.  Events should be rated according to the following parameters:

EVENTS RELATED


Definitely Related  

  • The event is a known effect of the drug, device, or procedure (e.g., listed in the protocol documents including IB, consent, publications)
  • The event follows an obvious sequence of time, from the drug’s administration, device’s implantation or activation, or procedure, for which the event is directly attributed to the administration, implantation, activation, or procedure.
  • The event ceases with discontinuation of the drug, device, or procedure (and reoccurs on restarting).
  • The event includes data that was only collected for the study.
  • The event included disturbing or upsetting questions that the subject was asked for the purpose of the research.

Probably Related

  • The event is lesser known or suspected effect of the drug, device, or procedure (listed in the protocol documents including IB, consent, publications, etc.)
  • The event follows a reasonable sequence of time from the drug’s administration, device implantation, activation, or procedure, for which the event may be attributed to the administration, implantation, activation, or procedure.
  • The event ceases or diminishes with discontinuation of the drug, removal/discontinued activation of the device, or procedure.

Possibly Related

  • The event is a lesser known or possible effect of the drug, device, or procedure.
  • The event occurred within a sequence of time from the drug’s administration, device implantation and/or activation, or procedure, for which the event may be attributed to the administration, implantation, activation, or procedure.
  • The event could be explained by the characteristics of the population under study.

EVENTS NOT RELATED 

Unlikely Related

  • The event is NOT a previously known or suspected effect of the test drug, device, or procedure.
  • The event does NOT follow a sequence of time from drug administration, device implantation and/or activation, or procedure, for which the event could be attributed to the administration, implantation, activation, or procedure.
  • The event can be readily explained by the characteristics of the population under study.

 Unrelated

  • The event is NOT known to be an effect of the test drug, device, or procedure.
  • The event does NOT follow a sequence of time from drug administration, device implantation and/or activation, or procedure, for which the event could be attributed to the administration, implantation, activation, or procedure.
  • The event can be readily and easily explained by the characteristics of the population under study.
  • Subject never received study drug, study device, or underwent research study procedure.

Step by step instructions for applying these guidelines appear below.

Reporting Procedures

For studies in eResearch (IRB web-based application system):
Open the approved study in eResearch. Click on AE/ORIO function tab in the left column (which looks like the screen shot shown to the here).                                   

 

 

 

  • Instructions for submitting an AE are available here. (PDF)
  • If the event necessitates an amendment to the protocol or informed consent document, you must submit an amendment after submitting the AE. If the AE obliges the investigator to inform previously enrolled subjects, include in the amendment the mechanism by which this will be done.
    • For example, sending a letter to all previously enrolled subjects, upload the letter in the amendment submission. 

 

Follow these steps if you are reporting a UM Event.

 

Review Step 1 The principal investigator should assess each adverse event by the following criteria. Note the answers, then refer to the timetable to determine the deadline by which the report should be submitted to the IRB.
Step 2 Do the IRB approved documents for this study include a detailed plan with a specific timetable or time schedule for AE reporting? (eResearch studies, see approved application section 32-1)
YES: Use the Study Specific AE Reporting Timetable NO: Continue below to Step 3
Step 3

Is the AE to be reported addressed or described in one or more of the following?

  • Informed consent document(s) for this study
  • IRB application for this study (IRB only, not applicable to FDA reporting and may not apply to sponsor required reporting--refer to sponsor protocol and agreement.)
  • Grant application or study agreement (IRB only, not applicable to FDA reporting and may not apply to sponsor required reporting--refer to sponsor protocol and agreement.)
  • Protocol or procedures for this study
  • Investigators' brochure or equivalent (for FDA regulated drugs or devices)
  • DSMB/DSC Reports (IRB only, not applicable to FDA reporting and may not apply to sponsor required reporting--refer to sponsor protocol and agreement.)
  • Published literature (IRB only, not applicable to FDA reporting and may not apply to sponsor required reporting--refer to sponsor protocol and agreement.)
  • Characteristics of the study population (IRB only, not applicable to FDA reporting and may not apply to sponsor required reporting--refer to sponsor protocol and agreement.)
  • Other (if documentation has not been submitted to the IRB previously it should be included in the AE submission) (IRB only, not applicable to FDA reporting and may not apply to sponsor required reporting--refer to sponsor protocol and agreement.)

YES the AE to be reported is EXPECTED

No the AE to be reported is UNEXPECTED

Step 4 Determine the association of the AE to be reported with the test article or test procedure (the interaction or intervention ):                                  

 

 

 

RELATEDNESS refers to the cause of the adverse event. Investigators should assess whether the event is attributable, in whole or in part, to the study intervention/agent.

If the investigator judges the event as being PROBABLY related to a concurrent standard therapy, but POSSIBLY related to the investigational therapy, report the event as "possibly related." Indicate on the reporting form the UM PI judgment regarding which part of the therapy the event should be attributed to. If the PI and sponsor disagree on the assessment, so note in the report.

Step 5 Based on the event's relatedness and expectedness, report it within the timeframe indicated on the Standard Adverse Event Reporting chart above.

 

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Updated July 22, 2015