Reportable Events: Application

This page describes the ED/SBS IRB Reportable Event application in ARROW.

The Reportable Event application should provide a concise explanation of the event, including: relevant dates, how the person reporting obtained the information, and any corrective action being proposed by the Study Team.

Event Type
On the first page of the application, select the type of event being reported.

  • Noncompliance:  Any failure by the study team to follow (1) federal regulations, state laws, or institutional policies relevant to human participants research, OR (2) the determinations of the reviewing IRB as documented in the approved IRB application and supporting materials.
See the campus Noncompliance policy and Deviations (minor deviations that do not require reporting to the IRB)
  • Unanticipated Problem:  An event that is reasonably related to the research and unexpected (in terms of nature, severity, or frequency) given the research procedures that are described in the study-related documents.
See the campus Unanticipated Problems policy
  • New Information:  Though seldom applicable to minimal risk research, New Information reports include notifying the IRB of new risk information and a related forthcoming change of protocol.  For example, a change in the local political or cultural norms at a international site that impacts the risk level, or a Principal Investigator's long-term absence from campus (which may or may not also require a PI change).

Complete the Reportable Event Application
As part of the review process for Noncompliance and Unanticipated Problems, the IRB will review proposed corrective actions to prevent the event from occurring again.  Explain if a Change of Protocol will be required in order to update consent documents, instruments, or other parts of the ARROW file.

Keywords:unanticipated problem, noncompliance, new information   Doc ID:67610
Owner:Kamie L.Group:Education and Social/Behavioral Science IRB
Created:2016-10-06 12:11 CSTUpdated:2019-04-16 12:14 CST
Sites:Education and Social/Behavioral Science IRB, VCRGE and Graduate School
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