UM Adverse Event Reporting

Use the information on this page to report adverse events that are "UM" events. These are events that involve subjects or others the UM investigator is responsible for and/or events for which a UM IRB has direct oversight. Please note that this guidance is for reporting to the IRB only and does not satisfy required reporting by an investigator to other internal or external oversight bodies or departments (e.g. the FDA, Sponsor, UMHS Compliance Office, DSMB, or Privacy Offices).

OTHER REPORTING TABLES: For external/non-UM events see the External AE Reporting page. Retrospective data analysis studies click here. Humanitarian Use Device (HUD) under a Humanitarian Device Exemption (HDE) click here.For studies with an IRB approved Study Specific Reporting plan refer to your plan and the Study Specific Adverse Event (AE) Reporting Timetable.For events that are not adverse events (no harm occurred) or reports to or from and oversight bodies see the Other Reportable Information and Occurrences (ORIO) Timetable.

Step by step instructions to assist in applying this chart appear below.

UM Standard Timetable

All reference to number of days herein refers to 'calendar days' rather than 'working days.'

Please note that this guidance is for reporting to the IRB only and does not satisfy required reporting by an investigator to other internal or external oversight agencies or departments (e.g. the FDA, UMHS Compliance Office, DSMB, or Privacy Offices).

Event Type

Report Expected Event to IRBMED

Report Unexpected Event to IRBMED

S

E

R

I

O

U

S

ADVERSE EVENTS or REPORT OF SAEs

Any event reported to another oversight body or agency

Concurrently (in relation to reporting) Reporting should occur in parallel or no later than five (5) calendar days to all oversight bodies or agencies

Death occurring within 30 days of last study intervention

Within 7 days of the event (or notification of the event) regardless of relatedness

Death occurring after 30 days of last study intervention if subject is still on-study or study follows subjects long-term

Within 7 days of the event (or notification of the event) if related

At time of Scheduled Continuation Application if unlikely or definitely not related

 

Life Altering Event : In-patient hospitalization or prolongation of existing hospitalization, a persistent or significant disability or incapacity or a congenital anomaly or birth defect.

Severe Social or Psychological Trauma: Loss of job, insurance, benefits; criminal prosecution, stigmatization of community/group, destruction of familial/social relations.

Life Threatening or Other Serious Adverse Event: Any event creating a life-threatening situation for the subject or others, regardless of whether or not medical intervention was required (e.g. severe asthma attack, assault, battery; threats of physical violence, any incident requiring security measures) or other serious adverse events requiring further monitoring.

In summary format with submission of Scheduled Continuation Application regardless of relatedness

Within 7 days of the event (or notification of the event) if related

At time of Scheduled Continuation Application if unlikely or definitely not related

Abnormal Preclinical Finding: Animal Finding or Safety-Quality Testing suggesting a significant risk for human subjects or others.

Not applicable

Within 7 days of of the event or notification of the event

Serious or Non-Serious
Unanticipated Problem Involving Risks to Subjects or Others: Any harm 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. (If the problem involved risk of harm but not actual harm, report as an ORIO)
N/A

Within 7 days of the event (or notification of the event) if serious and related

Within 14 days of the event (or notification of the event) if non-serious and related

NON-SERIOUS

ADVERSE EVENTS

Emergency and/or Urgent Treatment : Emergency Room, physician or other provider visit required to treat physical injury and/or emotional trauma or distress.

In summary format with submission of Scheduled Continuation Application regardless of relatedness

Within 14 days of the event or notification of the event if related

At time of Scheduled Continuation Application if unlikely or definitely not related

NOTE : Includes expected events of unexpected magnitude, duration, or frequency

Social or Psychological Trauma: Moderate or temporary distress, significant embarrassment, stigmatization of individual or community/ group, disruption of familial/social relationships, nontrivial emotional distress or upset

Moderate Adverse Event: Any other event which causes discomfort and requires treatment, but does not pose any significant or permanent risk or harm to the subject or require in-patient hospitalization.

Mild Adverse Event: Examples include minor infection at the site of a blood draw requiring only antibiotic ointment to treat, dizziness, minor emotional upset.

Do not report

At time of Scheduled Continuation Application if related and unexpected (i.e. the frequency, magnitude, or duration is greater than expected in everyday life)

 

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.

The 'Study-Specific' AE Reporting Option

Instead of using the timetable above, investigators can propose a plan designed for their study. A study-specific plan is encouraged for minimal to moderate risk studies that are not under FDA oversight. Many sponsored studies include an AE reporting plan. Know your options!.

Click here for more information.

Review Step 1 Follow these steps if you are reporting an UM Event.

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 when 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 to which part of the therapy the event should be attributed. If the PI and sponsor disagree on the assessment, so note in the report.

Step 5 In the Timetable above:
  • Find the general description under the heading "Event Type " that most closely describes or categorizes the AE to be reported
  • Scan right to expectedness as determined in Step 3
  • Timing of report based on association/relatedness as determined in Step 4

 

Back to top

Updated 3/6/12