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 - Modifications and Continuing Reviews 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.
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.
For all local Continuing Reviews, the latest version of each Informed Consent in myIRB will be attached. For all local Modifications, the latest Protocol and Consent Documents in myIRB will be attached only if the review resulted in a modification to the document. 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.
- From the Menu, navigate to Protocols > PC Console and enter the protocol number in the Select Protocol search field.
- Click the Reviews vertical tab, and then the IRB horizontal tab.
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.
This will bring up the Review Information. In the Details block for the document you wish to release, click the Release checkbox.
- Reconsent Required?: If a consent document was added, there will be a checkbox option in the Reconsent Required column.
- If the review caused changes to the consent form that require subjects to be reconsented, selecting this box will flag all applicable subject in the CRA Console with an RR superscript, indicating to clinical coordinators that reconsent is required. The RR superscript will remain until the new consent is entered for that subject.
- When this box is checked, a double arrow will appear next to it (image above). To narrow down which subjects the reconsent applies to, click the double arrows and a pop-up will appear listing subject statuses applicable to this protocol, including specific arms. Select only the statuses that require reconsent, and the RR superscript will only be applied to subjects currently in these statuses. All statuses will be selected by default.
- When this box is checked, a double arrow will appear next to it (image above). To narrow down which subjects the reconsent applies to, click the double arrows and a pop-up will appear listing subject statuses applicable to this protocol, including specific arms. Select only the statuses that require reconsent, and the RR superscript will only be applied to subjects currently in these statuses. All statuses will be selected by default.
Press Submit when you are finished.