Reportable Event Submission Instructions

Please note, these instructions pertain to protocols not yet approved in ARROW

For protocols in ARROW please refer to How to Complete Reportable Events .

Protocols submitted without the applicable materials below or accompanied by an incomplete or unsigned form will be returned and NOT scheduled for review.

Please submit the following documents to the Health Sciences Institutional Review Board Office, Suite 105 University Bay Office Building (UBOB) 800 University Bay Drive

Please provide:
  • The completed reportable event form signed by the Principal Investigator
  • Any supporting materials, such as a Data Safety Monitoring Board Report, Action Letter, journal article of audit report
  • If subjects will be informed of the reportable event related to this research study via letter, submit one (1) copy of the proposed correspondence for review
  • If a protocol amendment accompanies the report indicate this on the reportable event form and submit a Change of Protocol form that describes the changes to this document
  • If corrective action is necessary
    • Re-consenting subjects or revisions to the consent, provide one (1) copy of the revised consent form(s) with changes highlighted and one (1) copy of the revised consent form(s)
    • Changes to the protocol, provide one (1) copy of the revised protocol and one (1) copy of the revised initial review application

Keywords:unanticipated problem, adverse event, new information, noncompliance, protocol exception, deviation reporting   Doc ID:18310
Owner:Monica E.Group:Health Sciences IRBs
Created:2011-04-25 19:00 CDTUpdated:2015-10-13 15:13 CDT
Sites:Health Sciences IRBs
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