Modify/Update External IRB Studies

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Table of Contents

Before You Begin

What updates does HSD need for external IRB studies?

HSD requires limited ongoing information about externally reviewed studies. For more information:

Required Changes for External IRB Studies:聽

Change How to Initiate
Update UW PI Review Change Study PI Instructions
Update Zipline Application Access Review Update Study Team Instructions
Change Reviewing IRB Contact hsdrely@uw.edu to initiate
Planning to Implement E-Consent Multi-site External Studies:

  1. Update Study Details to provide revised External IRB Review Request Form. If the original External IRB Review request form did not include questions about E-Consent, upload the REQUEST External IRB Addendum eConsent.
  2. Create Site Modification (required if you need to add or revise the Other REDCap Installation supplement or Other E-Consent Tools Attestation Letter)

Single-site External Studies:

  1. Update Study Details
Report Study Closure Contact hsdrely@uw.edu to initiate

Steps for Updating Study Details

  • In the study workspace, click Update Study Details

screenshot of the update study details button

  • Provide a summary of the update (for example, adding e-consent)

screenshot of the study update information smartform in Zipline

You are now in a draft version of the study SmartForm and should be on the Basic Study Information page. Update the draft version of the study to reflect any changes being made by making all needed revisions to the SmartForms.

ADDING E-CONSENT:

To Add a Document:

  • Click Add
  • Select the new document from your computer
  • Click OK in the Edit Attachment window

screenshot of the add document button in Zipline

To Update a Document:

  • If needed, click the ellipsis by the document
  • Click Upload Revision or Update
  • Select the revised file from your computer
  • Click OK in the Edit Attachment window

screenshot of clicking the ellipsis to upload a revision of the external IRB request form

To Remove a Document:

  • Click the X by the document

screenshot of the delete document button in Zipline

Click Save and Exit out of the draft SmartForm once your changes are complete

鈥� HSD staff will finalize the update after your change has been assessed.

Steps for Site Modifications

This activity is only available for multi-site external studies

  • In the study workspace, click Create Site Modification

screenshot of the create site modification button in Zipline

  • Indicate that the purpose of the submission is Modification/Update
  • Indicate the modification scope (can select both options)
    • UPDATING ZIPLINE ACCESS: See Update Study Team for detailed instructions
    • ADDING E-CONSENT: Select 鈥淥ther Parts of the Site鈥�

screenshot of the modification purpose scope in Zipline

  • Add a summary of the changes

screenshot of the site modification summary smartform in Zipline

You are now in a draft version of the site SmartForm and should be on the Basic Local Site Information page. Update the draft version of the site to reflect any changes being made by making all needed revisions to the SmartForms.

ADDING E-CONSENT:

  • A site modification is only required if you need to upload the Other REDCap Installation Supplement or the Other E-Consent Tools Attestation Letter to the Local Site Documents page.
  • If not already done, update Study Details with the revised External IRB Review Request on the External IRB SmartForm page

To Add a Document:

  • Click Add
  • Select the new document from your computer
  • Click OK in the Edit Attachment window

screenshot of the add document button in Zipline

 

To Update a Document:

  • If needed, click the ellipsis by the document
  • Click Upload Revision or Update
  • Select the revised file from your computer
  • Click OK in the Edit Attachment window

screenshot of the update document button in Zipline

 

To Remove a Document:

  • Click the X by the document

screenshot of the delete document button in Zipline

  • Click Save and Exit/Finish to exit the SmartForm

  • Complete the Submit activity to send the modification to HSD for review

screenshot of the submit site modification button in Zipline

What to Expect After Submitting

Study Updates

An HSD staff member will be assigned to the study update as the IRB coordinator. They will communicate with you as needed about the update.

You may check the status at any time in the update workspace in Zipline. Once the update is finalized, the status will change to Updates Complete in Zipline.

Site Modifications

An HSD staff member will be assigned to the site modification as the IRB coordinator. The PI, any PI proxies, and the primary contact will receive email notifications:

  • If HSD staff need additional information or changes to authorize the modification
  • When your modification has been authorized

You may check the status at any time in the modification workspace in Zipline. Once the modification is authorized, the study status will change to Pending sIRB Review in Zipline.

screenshot of Pending sIRB Review state