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Changes: Application

This page describes the ED/SBS IRB Change application in ARROW

The Change application has two parts: the Change Application and the Modified Application.

Change Application
This portion provides a clear description of the proposed changes.  The Change Application is essentially a cover letter summarizing the changes made in the Modified Application.

The first page of the Change Application provides instructions on completing the New Change.
  1. Complete the Change Application, which will describe the changes you wish to make to the study.
    **Do NOT upload any revised documents to the Change Application. 
  2. Revise the Modified Application to reflect the proposed changes to the study by clicking the Edit Modified App button in the Change workspace. 
  3. If any study documents are being revised as part of the change, the revised documents must be uploaded to the Modified Application.
    For example, if the change involves revisions to the consent documents, upload these in the Informed Consent section of the modified application. 
    • Use the Upload Revisions (not the Delete button) to upload revised documents to the Modified Application. Using the Upload Revisions button will automatically replace the prior approved version of the documents being revised with the new version. 
    • Revised documents must have all changes tracked (in Word format). 
Modified Application
When a new study is approved, a snapshot is taken of the entire application.  When a New Change is opened, that snapshot is made available - as the Modified Application - to actually make changes to the approved study.  When a New Change is approved, a new snapshot is taken of the Modified Application.  The new snapshot should reflect the status of the study at that point going forward (until another New Change is submitted).

Revised Documents
As noted in the instructions on the Change Application (and above), any revised documents should ONLY be uploaded in the appropriate location of the Modified Application with CHANGES TRACKED.  Only upload one version of the revised document, no duplicates; the system will accept the tracked changes in approved documents.

Changes to Study Team Members
Changes to the study team can be made in the New Change application, along with other proposed changes.  If the only proposed changes are to the study team (excluding the PI and non-UW personnel), a shorter Personnel Change application should be submitted.  Please note that if you are ONLY removing personnel (excluding PI and non-UW personnel), you can use the Remove Personnel activity in the main application workspace instead of submitting a Personnel Change.  A FAQ on the Remove Personnel activity can be found here

Changes to the PI can only be made via a New Change application.  The current PI of record will be required to submit the change; the proposed new PI can only submit applications once the change is approved.

Changes for an Exempt Study
Please see our Investigator Responsibilities for Exempt Human Subjects Research guidance document for the types of changes that need to be submitted for an exempt study. A Personnel Change (excluding the PI and non-UW personnel changes) is not required for an exempt study; however, if you would like to submit a personnel change for an exempt study, you are welcome to.   

Keywords:change, new change, modifying, approved study, Personnel, study team   Doc ID:43065
Owner:Casey P.Group:Education and Social/Behavioral Science IRB
Created:2014-08-21 13:16 CSTUpdated:2019-05-16 11:37 CST
Sites:Education and Social/Behavioral Science IRB, VCRGE and Graduate School
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