Continuing Review: Process

This page describes the ED/SBS Continuing Review Process

Pre-Submission
The ED/SBS IRB Continuing Review application should be done well in advance of a study's expiration date.  Ensure the information provided is complete and does not report or request any proposed changes to the study.  Change and Personnel Change applications should be submitted as the study evolves.  Do not wait to submit Change or Personnel Change applications until close to the expiration date or along with the Continuing Review, as this may result in a slower review process for the study.

Once an ED/SBS IRB Continuing Review application has been filled out by the study team, the following steps should be performed:
  • Select Hide/Show Errors at the top of the application to identify any omissions;
  • Select Finish on the Final Page or Save & Exit on any page to return to the study workspace;
  • Use the Record Human Subjects Training Snapshot activity, to ensure all study team members have the required training;
  • To submit the application to the ED/SBS IRB, the PI must review and click the Submit activity in the application workspace.
When an application is successfully submitted, an entry will be logged on the History tab in the application workspace, noting the date and time of submission, and the Current State moves from Pre-Submission to IRB Administrative Review.

IRB Administrative Review
Once an ED/SBS IRB Continuing Review application has moved into IRB Administrative Review state, the application is no longer editable by the study team.  The ED/SBS IRB Submission Manager will review the application to ensure the application is ready for pre-review.  If there are missing documents or information, the application will be returned to the study team to address.

See ARROW FAQ: Responding to Issues

IRB Administrative Review is typically done within 1-2 business days from submission.

When the Submission Manager has determined the application is ready for pre-review, it will be assigned to a Staff Reviewer and move into IRB Pre-Review state.

IRB Pre-Review
An ED/SBS IRB Staff Reviewer will be assigned to pre-review an ED/SBS Continuing Review application to assess the application and supporting documents to determine the level of review required.  

See ARROW FAQ: Questions During Review to identify the assigned Staff Reviewer

If the Staff Reviewer finds information or documents missing, or needs clarification to be able to determine the type of review, the application will be returned to the study team to address.

See ARROW FAQ: Responding to Issues

When the Staff Reviewer finds the application to be complete, it will be assigned to the determined review type.  IRB Pre-Review is typically done within 7-10 days from submission.

See Continuing Review: Review Types & Timing

Expired
ARROW sends out reminder notifications to the PI, POC(s), and all study team members listed with edit/email rights well in advance of a study expiration date.  The IRB highly recommends submitting a Continuing Review well in advance of expiration dates to ensure there is no lapse in approval, in which all research activities would need to be stopped.  If a study has expired, additional questions will be generated, to address the expiration and research activities.



Keywords:pre-review, administrative review, addressing issues, reviewer notes, submit issues response   Doc ID:42688
Owner:Casey P.Group:Education and Social/Behavioral Science IRB
Created:2014-08-11 11:38 CSTUpdated:2019-01-17 16:15 CST
Sites:Education and Social/Behavioral Science IRB, VCRGE and Graduate School
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