The University of Mississippi Medical Center (UMMC) utilizes WCG Velos eResearch ("Velos") for submission and management of all human subjects research protocols to its institutional review board (IRB). UMMC also uses Velos for clinical research management, including participant management, invoicing, and collections.
All contracts and awards for clinical research studies (those intended to add to medical knowledge related to the treatment, diagnosis, and prevention of diseases or conditions) are processed through the Office of Clinical Trials (OCT). As part of this process, the OCT will create a study record in Velos upon assignment, to include study details and relevant attachments.
IRB and Participant Management Decision Trees [PDF]
Study personnel do not need to create records in Velos for clinical research studies being processed through the OCT. In order to submit to the UMMC IRB, the study team will click on the “protocol” icon, review the initial details and attachments, and initiate the “check and submit” process.
Human subjects research studies that are not processed by the OCT will be created by study personnel in Velos and submitted by the study personnel to the UMMC IRB. Currently only initial IRB submissions are being processed through Velos. Amendments, continuing reviews, closeouts, and problem reports should be submitted via the RedCap IRB portal until further notice.
All active studies are being added to Velos so that the study personnel can easily submit amendments, continuing reviews, and close outs via Velos in the near future.
Prospective clinical research studies (where participants are enrolled for prospective observation or interventions according to a schedule of assessments), regardless of funding source or lack thereof, will be managed via Velos.
The specific study management requirements are set forth below.
All participants affiliated with prospective clinical research studies (where participants are enrolled for prospective observation or interventions in a study intended to add to medical knowledge related to the treatment, diagnosis, and prevention of diseases or conditions) must be enrolled in Velos, regardless of study funding source, location, or patient status.
Yes, Velos participant management is required for all prospective clinical research studies. Participant management will enable us to accurately capture study financials, secure timely payment, ensure Epic enrollment compliance, and yield robust reporting. It will also facilitate IRB reporting.
You’ll first search Epic via Velos for the participant. If he/she is not found, you’re able to create a new participant record. However, it is vital that you complete a thorough search first to prevent duplicate records.
UMMC has procured this system as a campus wide clinical trial management system. The system will standardize and centralize participant management. Depending on what you are using REDCap to capture, you may be able to use Velos in lieu of REDCap. The system has study and patient level forms that can be built to meet your study’s needs. You may also use Velos to capture potential participant screening.
There are several Epic interfaces. First, the OCT will send the study record from Velos to Epic. Second, Velos will search Epic for patient records when adding a participant to a study. Third, when a participant is enrolled in Velos, the participant will automatically be associated with the study in Epic. Lastly, the study’s Velos billing calendar and associated pricing and research designation will feed to Epic.
The OCT will create study record for all clinical research studies being processed through the Office, to include the study details, attachments, statuses, and study teams tab, upon assignment. If the study has a confidential disclosure agreement (CDA) the OCT will create the study record upon agreement execution. If there is no CDA, the OCT will create the record upon initial receipt of study-related documents.