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Updating IRB Reviews

A system integration from myIRB to OnCore allows select IRB review information and status to flow from myIRB into OnCore.  When a WashU IRB submission is approved, you will 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.

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
    • Clinical Research Billing Support will upload 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.

The Clinical Research Billing Support (CRBS) office will upload the protocol and approved Informed Consent for studies utilizing MyIRB and have answered the MyIRB Application question 4.6 "yes" indicating a possible billing risk, which allows them to access the study in MyIRB.  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.

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