4. Local IRB Initial Review

Owned by Former user (Deleted)
Last updated: Oct 14, 2023 by Sonya Izadi

Updating IRB Reviews

A system integration from myIRB to OnCore allows select IRB review details and documents to flow from myIRB into OnCore.  When a WashU IRB submission is approved, you may need to update and supplement some of these details. When an external/central IRB submission is approved, you will need to add the information. Please see the External IRB Reviews - Request to Rely Process page.

Please also keep in mind that the Workflow includes budgeting and calendar building pre-approval. If you receive an updated protocol between myIRB submission and initial approval by any committee, you should notify the Financial Coordinator and the WU Coverage Analyst listed on the Staff page.

  1. From the Menu, navigate to Protocols > PC Console and enter the Protocol No. in the Select Protocol field. Once you select the protocol, the protocol information will display in the banner.
  2. Click Reviews in the vertical toolbar and click IRB in the horizontal toolbar.
  3. In the appropriate study site block (e.g., Washington University), locate the review you need to update and click Edit on the right side of the review. 
  4. Confirm that the information in the Review Information block is accurate and add any missing information as needed.

    1. Review Expires: This setting enables or disables the Expiration Date field for an IRB review.

      1. When set to Yes, the date entered in the Expiration Date field will be used.  All reviews integrating from the myIRB system will default to Yes.

      2. For reviews that will not expire, change to No; the Expiration Date field is disabled and no date is saved for the IRB review. The expiration dates will display as N/A in fields, headers, exports, and document/consent related areas throughout OnCore. 

Adding IRB Approved Documents

Uploading Documents - Who is Responsible?

Documents should be uploaded within seven days of IRB Approval. This is consistent with current WashU IRB requirements to activate an approved modification.

  • When WashU is the IRB of Record
    • Protocol and Consent documents are now auto-added via the integration with myIRB. Prior to April 22, 2022, Clinical Research Billing Support manually uploaded documents.
    • The Regulatory Coordinator for the protocol will release any documents that should be available via the document search and (if not a Consent document) in the PC Console > Documents/Info > Attachments/Links page.
  • When an External IRB is used:
    • The Regulatory Coordinator for the protocol is responsible for uploading documents. CRBS will not have this information.
    • The Regulatory Coordinator for the protocol will release any documents that should be available via the document search and (if not a Consent document) in the PC Console > Documents/Info > Attachments/Links page.

For all local Initial Reviews, the latest Protocol and Consent Documents available in myIRB will be attached.  If these documents should be available in the document search and (if not a Consent document) on the PC Console > Documents/Info > Attachments/Links page, the Regulatory Coordinator will have to release these. 

  1. From the Menu, navigate to Protocols > PC Console and enter the protocol number in the Select Protocol search field.
  2. Click the Reviews vertical tab, and then the IRB horizontal tab.

  3. In the appropriate study site block (e.g., Washington University), locate the Approved Initial Review that has been populated from myIRB and click the Edit hyperlink on the right.



  4. This will bring up the Review Information.  In the Details block for the document you wish to release, click the Release checkbox. 



  5. Press Submit when you are finished.

Need more help? Contact the OnCore Support Team: oncore@wustl.edu