Study Set-Up

Velos Clinical Trials Management System (CTMS)

WCG Velos eResearch is a comprehensive CTMS available for automating administrative, financial, and research activities. Designed to promote productivity and efficiency, Velos eResearch simplifies the management of the entire clinical research portfolio by linking study status, patient enrollment, calendars, budgets, electronic data capture and more. eResearch will also be used for submission to UMMC's IRBs.

All UMMC clinical research studies must be housed in Velos. Starting March 1, 2021, all new studies will be built in Velos by the OCT.
The Office of Clinical Trials (OCT) will create records for new clinical research studies in Velos at the outset of the activation process. Velos records for all prospective clinical research studies that start the activation process on or after March 1, 2021 will include a study calendar and budget. The OCT will also handle invoicing for those studies that are industry-sponsored.
During the activation period, study team members can view current status and relevant documents in Velos. Once the study is activated, the relevant clinical research coordinator (CRC) will conduct patient management in Velos, which will then feed into the Epic electronic health record system. CRCs will also log administrative, invoiced items such as monitoring visits, Institutional Review Board (IRB) amendments, audits, etc. into the system. The relevant OCT Project Manager will then invoice the sponsor/clinical research organization based on the CRCs' Velos input, as well as track collections in the system.
Investigators, business administrators, and division and department chairs will be able to run reports on particular studies and their clinical research study portfolios.

All initial submissions to the IRB should be submitted via Velos eResearch. Amendments, continuing reviews, problem reports, and closeouts for initial submissions approved in Velos should be submitted in Velos.
Beginning June 1, 2021, continuing reviews for existing studies (initial applications approved in Ideate or RedCap) should be submitted via Velos eResearch.
Beginning July 1, 2021, amendments for existing studies should be submitted via Velos eResearch
Decision Tree for IRB Submissions

**Learning Resources**
Topic	JobAid	Video
General
Changing the Home Page/Changing Your eSignature	Changing the Home Page/eSignature	Video (1:16)
IRB
Creating an Initial Submission	Creating an Initial Submission	Video (8:54)
Submitting a Continuing Review, Amendment, Problem Report, or Closeout	Submitting a Continuing Review	Video (2:17)
Checking Your IRB Status	Checking Your IRB Status	Video (2:39)
Updating Your CITI Training Expiration Date		Video (1:16)
Study/Patient Management
Adding a Participant	Adding a Participant	Video \| eResearch View (3:13) Video \| Study Patient Roster View (1:29)
Updating a Participant Status	Updating Participant Status	Video (1:44)
Patient Management Summary	Patient Management Summary	Video \| eResearch View (2:53) Video \| Study Patient Roster View (1:45)
Search for an Existing Study	Search for an Existing Study
Updating Schedules and Visits	Updating Schedules and Visits	Video \| Updating Schedule (eResearch View) (1:39) Video \| Updating Schedule (Study Patient Roster View) (1:26) Video \| Adding an Unscheduled Visit (eResearch View) (1:43) Video \| Adding an Unscheduled Visit (Study Patient Roster View) (1:46)

In order to receive a Velos account, UMMC personnel must complete Velos training.

To request CTMS training, email Kyle Bennett.

To complete IRB training, enroll in the WCG Velos eResearch - Introduction to IRB Submission course in Healthstream.