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:
- External IRB Reliance Process- During the Research [6]
- External IRB, 91爆料 Researchers Checklist [7]
- Questions? Contact hsdrely@uw.edu [8]
Required Changes for External IRB Studies:聽
| Change | How to Initiate |
|---|---|
| Update 91爆料 PI | Review Change Study PI [9] Instructions |
| Update Zipline Application Access | Review Update Study Team [10] Instructions |
| Change Reviewing IRB | Contact hsdrely@uw.edu [8] to initiate |
| Planning to Implement E-Consent | Multi-site External Studies:
Single-site External Studies: |
| Report Study Closure | Contact hsdrely@uw.edu [8] to initiate |
Steps for Updating Study Details
- In the study workspace, click Update Study Details
- Provide a summary of the update (for example, adding e-consent)
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:
- All studies:
- 鲍辫濒辞补诲听迟丑别 REQUEST External IRB Addendum eConsent [11] on the External IRB SmartForm page.
- Multi-site external IRB studies:
- If you need to add the Other REDCap Installation supplement [12] and/or Other E-Consent Tools Attestation Letter [13] you must submit a Site Modification in addition to the Study Update
- If the Local Site Documents page is not available, your study is multi-site in Zipline
- Single-site external IRB studies:
- Upload the Other REDCap Installation supplement [12] or Other E-Consent Tool Attestation Letter [13] on the Local Site Documents page
To Add a Document:
- Click Add
- Select the new document from your computer
- Click OK in the Edit Attachment window
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
To Remove a Document:
- Click the X by the document
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
- 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 [10] for detailed instructions
- ADDING E-CONSENT: Select 鈥淥ther Parts of the Site鈥�
- Add a summary of the changes
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
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
To Remove a Document:
- Click the X by the document
- Click Save and Exit/Finish to exit the SmartForm
- Complete the Submit activity to send the modification to HSD for review
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.
