Reportable Events Guidance for WIRB Submissions

Guidance regarding reportable events (promptly reportable information)

Due to the nature of these events, research teams submit unanticipated problem reports (promptly reportable information) directly to WIRB via the WIRB Connexus portal.  WIRB will provide notice to the UW WIRB Gateway Team of any significant reports.

Submitting Promptly Reportable Information to WIRB:

The Promptly Reportable Information is uploaded directly by the study team to WIRB through WIRB Connexus.

Keywords:AE, unanticipated problems, SAE, adverse events, serious adverse events, promptly reportable information reportable events   Doc ID:33896
Owner:Brandy S.Group:Western Institutional Review Boards
Created:2013-09-23 15:43 CSTUpdated:2017-10-05 10:17 CST
Sites:Western Institutional Review Boards
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