Study Specific Timetable

Event or Report of Event

UM adverse event or unanticipated problem reported to an oversight body

(Reports from the investigator to the FDA, DSMB/DSC, OBA, sponsor or others)

Concurrently with report to other oversight body or sooner as required immediately below

eResearch : UM Serious Adverse Event Reporting Form or UM non-serious Event Reporting Form based on the seriousness of the event

IRBMED Legacy: Previously Approved Project Application sections 1-3 and 6.

UM event of any severity designated in the AE Reporting Plan, DSMP, or IRB appapplication as reportable to the UM-IRB

(i.e. Some IRB approved plans either allow the investigator additional time to report to the IRB after reporting to another oversight body OR require reporting to the IRB sooner than to other oversight bodies. You must refer to and follow the IRB approved plan)

As required by the study AE Reporting Plan/ DSMP

eResearch : UM Serious Adverse Event Reporting Form or UM non-serious Event Reporting Form based on the seriousness of the event

IRBMED Legacy: Previously Approved Project Application sections 1-3 and 6.

URGENT DSMB/DSC , Sponsor, OBA , or other report where one or more of the following applies:

• an unanticipated problem is identified
• a change to the research is required
• the risk/ benefit ratio of the study is negatively impacted
• subjects' willingness to participate is or would be affected

(These are reports received by the investigator from the outside source)

Within 7 days of PI receipt

eResearch : Use ORIO Form: "Report(s) to or from oversight entity"

IRBMED Legacy: Previously Approved Project Application sections 1-3 and

NON-URGENT DSMB/DSC , Sponsor, OBA , or other report where none of the criteria bulleted in the cell above applies.

(These are reports received by the investigator from the outside source)

In summary format prior to submission of Scheduled Continuation Application (IRB renewal)

eResearch: Use ORIO Form: "Report(s) to or from oversight entity"

IRBMED Legacy: Use the Previously Approved Project Application sections 1-3 and 10 (NOTE, can be submitted WITH the renewal)

Additional Considerations: To report social, psychological, or non-physiological events see number two below.

Any other UM adverse events that the DSMP may not explicitly require be reported to an oversight body should be reported to IRBMED if they occur with unexpected magnitude, duration, or frequency . Report with the study renewal (the Scheduled Continuation Application ) unless otherwise warranted.