Changes: Process

This page describes the ED/SBS IRB Change process

Change applications should be submitted as needed; do not wait for annual review or expiration dates to make changes to a study, as this will slow the review processes down.  Each study can only have one open Change application.  If the New Change button is not available for a given study, review the Change tab in the study workspace to look for an open Change.  

Once an ED/SBS IRB Change application has been filled out by the study team, the following steps should be performed:
  • Ensure the Change Application is complete AND the Modified Application reflects all of the proposed changes;
  • 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 Change 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 Change application workspace.
When an application is successfully submitted, an entry will be logged on the History tab 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 Change 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.

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

IRB Pre-Review
An ED/SBS IRB Staff Reviewer will be assigned to pre-review an ED/SBS Change 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.

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.

Keywords:pre-review, administrative review, addressing issues, reviewer notes, submit issues response, changes   Doc ID:43069
Owner:Casey P.Group:Education and Social/Behavioral Science IRB
Created:2014-08-21 13:32 CSTUpdated:2021-08-23 07:18 CST
Sites:Education and Social/Behavioral Science IRB, VCRGE and Graduate School
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