Change Applications

How to create a Change in ARROW.

Completing a Change in ARROW requires study teams to provide information in different forms within the Change workspace. Please follow the steps below when completing a Change in ARROW:

Step 1: New Change 

To create a new Change, click the New Change button in the main study workspace for a study in the Approved state. This will open up the Change Application, which includes both substantive and administrative changes.

Step 2: Change Application

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. Revised documents will be uploaded in the Modified Application, as described in Step 5 below. Click Exit when the Change Application is complete.

Step 3: Change Workspace 

After clicking Exit in the Change Application, ARROW will prompt you to "Proceed" back to the Change workspace. On the left side of the Change workspace, you will then see a button labeled Edit Modified Application.

Step 4: Edit Modified Application 

Click the Edit Modified Application button. This will take you to a copy of the currently approved IRB application for this study. You must then revise the IRB application to reflect the changes you described in the Change Application.

Step 5: Revised Documents 

If any study documents are being revised as part of the Change, you must upload the revised documents when making your revisions to the Modified Application.

For example, if the Change involves a revised survey, you will upload the revised survey to the appropriate section of the Modified Application. Similarly, revised consent documents must be uploaded in the Informed Consent section of the Modified Application.

Tips for Completing Changes

*In order to submit a Change, the Change Application must be completed AND the Modified Application revised to reflect the changes described in the Change Application.

*Once a Change has been submitted in ARROW, a second Change for that study cannot be submitted until the first Change has been either approved or withdrawn.




Keywords:Change applications, ARROW, Modified application   Doc ID:26088
Owner:Casey P.Group:ED/SBS IRB - ARROW Help
Created:2012-08-26 14:02 CDTUpdated:2018-10-16 15:11 CDT
Sites:ED/SBS IRB - ARROW Help, VCRGE and Graduate School
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