Clinical Research Services
The Center for Clinical and Translational Research at Virginia Commonwealth University established the Clinical Research Services.
Our mission is to augment, cultivate, facilitate and refine high-quality, subject-oriented clinical research. Our primary customers include investigators, research and administrative staff and funding organizations. We also partner with the VCU Health System, Office of Sponsored Programs, the IRB and other university and hospital service providers to standardize, streamline and support clinical research.
The safety and support of research participants is paramount. We provide clinical research training, expertise and opportunities; enhance administrative, operational and resource efficiencies to support clinical research; and support the discovery of safe, effective and timely treatment options for the communities we serve.
While our mission is to provide mechanisms for quality clinical research, the overarching goal is to improve the overall health and wellness of our community.
CRS Notification to All Investigators and Clinical Research Teams- “Change in Recovery of Charges Associated with the Utilization of Clinical Research Services (CRS)”
May 15, 2014
Due to NIH expectations that CTSA's will transition from a GCRC model to a cost recovery model, CRS is now considered a Service Center. As a result, the previous practice of discounting or waiving charges for non-industry clinical research is being phased out. As of June 1, 2014, all grant proposal submissions, regardless of funding source, that will require the utilization of any CRS resources must be submitted using the CRS Intake Form. The CRS staff will then provide a pre-study cost assessment and/or a CRS service agreement that will outline the charges for use of specific CRS services and describe the responsibilities of CRS staff, Principal Investigator, and study team members. Charges for all industry sponsored clinical research, as well as charges associated with clinical research funded by NIH, other agencies or internal sources of funding will be expected to be paid based on the CRS service agreement. It should be expected that once the clinical research is funded, costs associated with utilization of CRS services will not be waived. For more details regarding timelines for changes in recovery of charges associated with CRS resources, please review the Clinical Research Services Notification . For grants funding clinical research submitted prior to June 1, 2014, where CRS was not involved in the budgeting process, recovery of charges associated with utilization of CRS resources will be evaluated on a case-by-case basis.
Special announcement: New federal mandate for clinical trial billing
Effective Jan. 1, 2014, the Centers for Medicare & Medicaid Services will require inclusion of the 8-digit National Clinical Trial Number on claims associated with clinical trial participation. Clinical trial related claims submitted to Medicare for dates of service on or after Jan. 1, 2014 will be returned to the provider if the clinical trial number is not present. For more information, please read our informational flier.
WIRB submissions in RAMS IRB and ICF injury clause review
All new WIRB submissions from VCU must be submitted to the VCU IRB and not directly to WIRB. Beginning Aug 1, 2013, all WIRB protocols will be submitted through RAMS-IRB. At that time, there are several procedural changes that will occur. Please click here to review the submission steps.
To request any Clinical Research Services, please complete the CRS Intake Survey. Following the survey submission, the CRS resources and services requested will be reviewed. If any additional information is needed, a CRS representative will contact you.
If you are a sponsor and would like to consider VCU as a site for a study, please contact Shirley Helm at (804) 628-2942, Sara Twombly at (804) 628-3221 or CRSAdmin@vcu.edu.