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Closing a Protocol

A study may be closed when all of the following apply:

  • All subject recruitment and enrollment is complete (i.e., no new subject recruitment or enrollment are ongoing)
  • All subject specimens, records, data have been obtained (i.e., no further collection of data/information from or about living individuals will be obtained)
  • No further contact with subjects is necessary (i.e., all interactions or interventions are complete and no further contact with enrolled subjects is necessary)
  • Analysis of subject identifiable data, records, specimens are complete (i.e., use or access to subject identifiable data is no longer necessary. Note: this includes review of source documents by study sponsors.

In order to close an IRB protocol officially, submission of a Closing Report is required.

Once the closing report has been received by the IRB, a confirming e-mail will be sent to the Lead Researcher (LR), and "cc:" to the Administrative Contact and Faculty Sponsor (if applicable), to document protocol closure.

Note: The official retention period for UCI's IRB records begins on the date a closing report is submitted to the IRB by the LR. For more information about the LR's IRB record retention responsibilities, please see Lead Researcher Recordkeeping Responsibilities and Preparation and Maintenance of a Research Audit File.

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