ReGI Submission Tips

Use the tips below to troubleshoot common questions about submitting and managing studies in Research Gateway IRB (ReGI). If you don't see your question here, please submit your question via Ask Andy. 

1. Exempt Studies: Frequently Asked Questions
2. How do I submit my study? Why don't I see the submit button? How do I know if my submission was received?
3. Uploading Revised Documents vs. New Documents
4. Where can I find my study documents and approved consent forms?
5. Two Steps That Keep Your Modification Moving

1. Exempt Studies

2. How do I know my submission was received?

• Check the orange highlight on your workspace flowchart to see your current study status. The orange highlight indicates where the submission is in the workflow.

• Clicking Finish on the form only saves your work. Your study is not submitted to the IRB until the PI or a PI Proxy clicks Submit from the left-side menu of the workspace.

• If you do not see the Submit button, confirm that you are assigned as a PI Proxy or that you are listed as the PI on the study. Only the PI and assigned PI Proxies have permission to submit a study.

• Refer to the applicable user guide on the IRB Training & User Guides section for step-by-step instructions on how to submit the study. 

Pre-Submission
The submission is still with the study team. It has not been submitted yet. To fix: The PI or PI Proxy must click the 'Submit' button on the left menu.

Pre-Review

Success! The submission has been received by the IRB.

3. Uploading Revised Documents vs. New Documents

Please see the ReGI user guides for more detailed instructions. 

Revised Document	Navigate to the field in the submission SmartForm where you originally uploaded the document.   Click the Update button next to the document and then upload the revised document. ⚠️ Remember to enable tracked changes when revising a previously submitted Word document.
New Document (never previously submitted to the IRB)	Navigate to the field in the submission SmartForm where you need to upload the new document.   Click Add and follow the prompts to upload the file.

4. Finding Study Documents, Including the Approved, Stamped Consent Forms 

In the Documents tab on the study workspace, ReGI maintains draft and final versions of documents.

Draft Version:	The draft document is the working copy that study teams can update during a modification or when responding to clarification requests. Click on the draft document to download a copy to your computer for editing. Remember to turn on tracked changes when editing Word documents.
Final Version:	When the submission is approved, the draft becomes the new final version.  For consent forms, the final version is the IRB-stamped PDF. If you do not see the final version, it means the document has not been approved yet.

5. Two Steps That Keep Your Modification Moving

We want to help you avoid two issues we've seen come up often in modification submissions over the past few weeks. A quick check before you submit can save you a round of back-and-forth.

Note: These tips are specific to modifications that involve changes other than adding or removing non-PI study team members.

#1: Update the IRB Application (Word Document)

You will likely need to update the IRB Application document to reflect the proposed modifications, then attach the document to your ReGI submission.
 

#2: Use tracked changes

Use Track Changes when modifying Word attachments (IRB Application, consent forms, recruitment materials, etc.) and upload them to ReGI with tracked changes visible. Submissions without visible tracked changes may be returned. ⚠️

Instructions about how and when to use tracked changes are included in the following guides:

• 1st Modification for a Migrated Study
• Modifications for Non-Migrated Studies or Migrated Studies With an Approved IRB Application Document
• Respond to IRB Requests