How to Complete Changes of Protocol

Completing a change of protocol involves a few different steps. This process is the same for both full and expedited changes of protocol. For information on submitting personnel changes, see Personnel Change Guidance

  1. Create a change.

    Click the New Change button in the main study workspace. This will open up the change of protocol application.
NewChange_NewUI.PNG
  1. Complete the change application.

    Describe the changes you wish to make to the study. Any documents being revised as part of the change will be uploaded in the modified application, as described below. When the change application is complete, click "Exit" in the upper right-hand corner to return to the change workspace.
ChangeExit_NewUI.PNG
  1. Edit the modified application.

    After completing the change form, the IRB-approved version of the application will need to be revised to reflect the changes you wish to make to the study. To revise the application, click on the Edit Modified Application button on the left-hand side of the change workspace.
ChangeinPre-Submission_NewUI_EDITMODAPP.PNG
  1. Upload revised documents, if applicable.

    If any study documents are being revised as part of the change of protocol, they will need to be added to the modified application. To do so, ONLY use the Upload Revision button; do NOT use the delete button to provide revised documents. Other things to keep in mind when revising study documents:

    • Always use track changes when revising study documents.
    • If you are revising a document with a version date or number, please update the version date or number when making your revisions.
Uploadrevision_NewUI.PNG
  1. Submit the change to the IRB.

    Click Exit at the top of the screen. That will bring you back to the change workspace. If you are ready to submit your change, please click “SUBMIT” under My Activities on the left hand side of the screen.
ChangeinPre-Submission_NewUI_SUBMIT.PNG
  1. Respond to reviewer notes.

    Once the change has been received by the IRB Office, it will be assigned to a staff reviewer for pre-review. Staff reviewers assigned to changes may have notes in both places, and when a change is sent back to a study team, ARROW will specify the question location.
ModificationsRequested_NewUI.PNG

Return to top



Keywords:CP, change, expedited, full   Doc ID:17381
Owner:Faye L.Group:Health Sciences IRBs
Created:2011-03-21 19:00 CDTUpdated:2018-05-30 21:51 CDT
Sites:Health Sciences IRBs
Feedback:  12   5