IRBMED - UMMS

Standard AE Reporting

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 documents include a detailed plan (e.g. a Data Safety Monitoring Plan [DSMP]) with a specific timetable or time schedule for AE reporting?
	YES, Follow Study Specific AE Reporting	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 Grant application or study agreement Protocol or procedures for this study Investigators' brochure or equivalent (for FDA regulated drugs or devices) DSMB/DSC Reports Published literature Other (if documentation has not been submitted to the IRB previously it should be included in the AE submission)
	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 ): definitely related probably related possibly related unlikely to be related definitely not related (unrelated) 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 below: 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
Step 6	Refer to the Reporting Procedures below the Timetable.

Standard Timetable
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	Concurrently with report to other oversight body or sooner as required below
	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 definitely, probably, or possibly related. With 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 definitely, probably, or possibly related. With Scheduled Continuation Application if unlikely or definitely not related
0 T H E R ADVERSE EVENTS or REPORT OF AEs	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 15 days of the event or notification of the event if definitely, probably, or possibly related With 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.
	Abnormal Preclinical Finding: Animal Finding or Safety-Quality Testing suggesting a significant risk for human subjects or others.	Not applicable	Within 15 days of of the event or notification of the event
	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	With submission of Scheduled Continuation Application if the frequency or duration is greater than expected in everyday life

Reporting Procedures

For studies in Legacy (IRBMED paper-based application system):

For studies in eResearch (IRB web-based application system):

Report to the IRBMED on a Previously-Approved Project Application. Follow the instructions provided for section 1-3 and 6. If you are submitting a Follow-Up Report for an adverse event previously submitted, fill out sections 1, 2, 3 and 10 (not 6).

Include section 8 if the event necessitates an amendment to the protocol. If the event obliges the investigator to inform previously enrolled subjects, include in section 8 the mechanism by which this will be done. For example, if a letter will be sent to all previously enrolled subjects, submit the letter and section 8.
Include section 11 if the event necessitates a change in the informed consent document.

Note that the "acknowledgement fax number(s)" are the only numbers to which the IRBMED Office will send an official acknowledgement of any adverse events you report.

Click on AE/ORIO function tab in the left column of the study' s work-space ( which looks like the screen shot shown to the here).

Instructions for submitting an AE are at http://www.umich.edu/~eresinfo/docs/ae.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.