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 4. External IRB Reviews - Modifications and , Continuing Reviews, Closure page.
- 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.
- Click Reviews in the vertical toolbar and click IRB in the horizontal toolbar.
- 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.
- Confirm that the information in the Review Information block is accurate and add any missing information as needed.
Review Expires: This setting enables or disables the Expiration Date field for an IRB review.
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.
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.
- indicate when Reconsent is Required by selecting the Reconsent Required? checkbox along with applicable subject statuses
- When an External IRB is used:
- The Regulatory Coordinator for the protocol is responsible for uploading 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.
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