How to Complete Changes of Protocol

How to Complete Changes of Protocol

Completing a change of protocol in ARROW is similar to the current paper process, but requires study teams to provide information in different forms within the change of protocol workspace. Please follow the steps below when completing a change of protocol in ARROW:

STEP 1: To create a new change of protocol, click the New Change button in the main study workspace for a study in the Approved state. This will open up the change of protocol application, which includes both the full and expedited change of protocol applications.


STEP 2: Complete the change of protocol application, which will describe the changes you wish to make to the study. Do NOT upload any revised documents to the change of protocol application. Revised documents will be uploaded in the modified application, as described in Step 5 below. Click finish when the change application is complete.

STEP 3: After clicking finish in the change application, ARROW will take you to a new workspace for the change of protocol. On the left side of the change workspace, you will see a grey Edit Modified Application button.


STEP 4: Click the Edit Modified Application button. This will take you to a copy of the currently approved IRB application for this study. You must revise the IRB application to reflect the changes you described in the change of protocol application.

STEP 5: If any study documents are being revised as part of the change of protocol, you must upload the revised documents when making your revisions to the IRB application. For example, if the change of protocol involves a revised study protocol, you will upload the revised protocol in response to the first question in the Study Summary section of the application that asks for a copy of the study protocol. Similarly, revised consent or authorization documents must be uploaded in the Informed Consent or HIPAA section of the modified application. For additional guidance, see Working with Revisions to Study Related Documents in ARROW . NOTE: Revised documents uploaded to ARROW must have all changes tracked.

Tips for Completing Changes of Protocol

  • Do NOT upload revised documents in the change of protocol application. Any revised documents must be uploaded – with changes tracked - ONLY in the modified application
  • In order to submit a change of protocol, 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 of protocol for that study cannot be submitted until the first change has been either approved or withdrawn.

See Also:

Keywords:CP, change, expedited, full   Doc ID:17381
Owner:Faye L.Group:Health Sciences IRBs
Created:2011-03-21 19:00 CDTUpdated:2015-10-13 15:08 CDT
Sites:Health Sciences IRBs
Feedback:  12   4