The WCG IRB tab is a feature available for both WCG Velos eResearch and WCG Velos eResearch eXpress that enables study teams to directly submit study documentation to the WCG IRB for approval. The WCG IRB tab streamlines the process of submitting documentation to WCG IRBs for the WCG IRB to perform ethical review of the submitted documents.
Note: The WCG IRB functionality is an opt-in feature, and therefore must be configured and turned on by the Velos team. For more information about this functionality, please contact Velos Support.
Before using the WCG IRB tab, the following items must be completed:
▪ Define a Principal Investigator for the study on the StudySummary tab
▪ Enter the Sponsor Protocol Number in the Sponsor Protocol Number field of the StudySummary tab
▪ Add all documents that need to be submitted for IRB review to the Attachments tab and place them in the Freeze status
The process workflow begins by adding your protocol / site documents to the Attachments tab within a study in WCG Velos eResearch. After adding your completed documents to the study, they then need to be placed in the Freeze status to enable them to be transmitted to the WCG IRB. Once the version has a Freeze status, documents can be added.
Warning: If you do not place your documents in the freeze status, they will not be available to submit for WCG IRB approval.
Once the documents are added, they can be transmitted via the WCG IRB tab within that study. As individual submissions are processed, their status will be updated to reflect their most recent processing state each time the study management>WCG IRB page is loaded. A high-level overview of this process is displayed below:
When this feature is enabled, an additional tab, WCG-IRB displays on the Study Management page:
