SOM Clinical Trials Office
About
The CTO offers a variety of services including CRC mentoring, protocol development and preparation, continuing education, monitoring, and quality assurance. These consulting services are made available to SOM investigators and coordinators to promote the smooth and efficient conduct of their research studies.
News
Clinical Trials Unit
The School of Medicine is committed to offering investigators the support they need to conduct high-quality, human subject research. Watch this space as we develop a centralized and full-service infrastructure so that clinical research can be conducted in a methodologically sound, compliant, efficient, and cost-effective manner.
CRCONNECT 2.0
The School of Medicine CTO Office has been developing the newest version of CRConnect and have worked diligently to provide a more efficient and streamlined study start-up process. Here are some of the notable enhancements our team has made to the application:
- Studies are inputted into Protocol Builder first and it will automatically transfer to CRConnect 2.0.
- All personnel information is pulled automatically into CRConnect 2.0 and you can adjust notifications accordingly.
- If you need to edit a certain step, you have the ability to “Start Over” and make your edits without having to reach out to support to re-open a step.
- DocuSign is no longer used, the approvals are done within the system and documents are auto-generated with the approval.
- Studies are broken out into categories based on where they are in the study process. This can be seen on the main dashboard of your account.
- You can easily access all uploaded documents using the drawer on the side of the webpage.
We are very excited to bring this newest version of CRConnect to the School of Medicine and will provide details on the implementation plan once it is completed.
IRB Fees
As of July 1, 2023, the University of Virginia implemented a new fee structure for industry-sponsored clinical trials requiring full board IRB review. This new fee structure applies to all studies for which the Clinical Trial Agreement (CTA) is executed on or after July 1, 2023.
The fee will be charged for studies for which the UVA IRB HSR is the IRB of record as well as those studies that are being conducted under a non-UVA IRB.
The revised fee structure is as follows:
| Service | Charge |
| UVA-HSR as IRB of record: initial review | $3,500 |
| Reliance on an outside IRB: initial review | $3,500 |
| UVA-HSR as IRB of record: yearly fee (billed at annual continuation) | $2,000 |
| Reliance on an outside IRB: yearly fee (billed at annual
continuation) |
$1,000 |
| UVA-HSR serving as sIRB of record for non-UVA sites:
initial review |
$1,000 per site |
| UVA-HSR serving as sIRB of record for non-UVA sites:
yearly fee (billed at annual continuation) |
$500 per site |
| Study close-out | $2,500 |
Note: The fee is considered a direct cost and is subject to F&A. Information regarding F&A may be found on the Office of Sponsored Programs.
Questions regarding this fee may be referred to the School of Medicine Clinical Trials office at 434-924-8570.
Available Services
Contacts
Sponsor Visits
Mentoring
Registration and Results Reporting (Clinicaltrials.gov)
DocuSign
Continuing Education
Working with the Virginia Nurses’ Association to provide contact hours, the CTO offers training and education focusing on the various aspects of clinical trials. This education is designed to keep CRCs and PIs abreast of current trends in the conduct of clinical trials.
Contact hours are provided for:
- Annual continuing education series
- External audio conferences (certificates of attendance)
See more in the Education and Mentoring section.
CRC Resource Guide
This resource guide was developed by the Clinical Trials Office to help navigate some of the many resources available to our clinical research staff. While this guide contains a great deal of information, it is not a complete inventory of resources. We encourage you to return to this guide over time as content is updated in efforts to keep the information current.
CRConnect
Clinical Research Connect is a hub to help you get organized for the study start-up, with instructions and steps of what’s needed, and which systems are involved. CRConnect provides opportunities to collaborate within the study team, where everyone will know where steps are and have access to the most updated information. This system will also provide single data entry and a more streamlined process for many study start-up components.
The CRConnect link can be accessed here. Please feel free to reach out to CRConnect Support with any questions as you begin to work on your study start-up.
CRConnect 2 is currently in development and once the application is live, it can be accessed here.
The goals of implementing CRConnect across the School of Medicine are:
- The ability to capture study start-up data electronically
- Centralized, electronic submission & approval processes
- Auto-generation of documents and forms
- Automation of email notifications and process status
- Integrated electronic document signature process
- Clear visibility as to:
- What compliance requirements and approvals the study requires and the approval status of each
- The status of HSR/IRB Submission
- The status of HSR/IRB Approval
- The study “Open for Enrollment” status
Email: CRConnectSupport@uvahealth.org
Phone: 434.297.5757, Option 2
OnCore
Online Collaborative Research Environment (OnCore) is a web based, comprehensive clinical trial management system (CTMS). OnCore will support our investigators and research coordinators as a centralized place to manage all of their study protocols and subjects.
The goals of implementing OnCore across the School of Medicine are:
- To improve day to day workflows
- To improve subject safety
- To improve budget and financial management
- To have more robust strategic planning within departments and as an institution
- To increase transparency and institutional oversight
The website address for OnCore is https://uva-oncore-prod.advarra.app. New users will have to complete OnCore training before having access.
Academic research centers, health care systems and cancer centers across the country use OnCore for managing their clinical trial information. Notably, OnCore is used at other large research institutions including Yale University, Indiana University, University of California – San Francisco and Virginia Commonwealth University, to name a few.
Email: oncoresupport@uvahealth.org
(note: please do not include PHI in communications to OnCore support account)
Phone: 434.297.5757 Option #1