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Services

About the Services the VCU CTO Provides

In addition to the VCU CTO educational programs and administrative efforts toward streamlining clinical trials processes, the VCU CTO has been identified by the Vice President for Research and the VCU Center for Clinical and Translational Research (CCTR) to provide key services in support of improved compliance and operations for all VCU clinical trials as part of the research submission process.

VCU's definition of a Clinical Trial

Learn VCU's definition of a clinical trial here.

Clinical Trial Routing Procedures

All clinical trials are routed to the VCU CTO for specific review features. In order to maximize efficiency, routing procedures differ based on submission type.

  • Industry-Sponsored, non-sponsored and all other trials with immediate start up
    • are routed through the VCU CTO prior to submission to the VCU OSP (as applicable).
  • Federally-sponsored and all other trials with start-up pending a competitive award process
      • are routed through the VCU CTO concurrently with electronic submission to the VCU OSP and as a part of the award notification process.

VCU Clinical Trials Office Service Profile

Download a printable version of the VCU CTO Service Profile

Descriptions of Services

  • Regulatory Review and Routing
    The CTO is required to review all clinical trials sponsor submission packages, in collaboration with the VCU OSP. Contact the VCU CTO at 804.628.2961, or email CTOAdmin@vcu.edu for more information.

  • Distributions of Clinical Trial Checks from Sponsors
    As checks are received and processed by Grants and Contracts Accounting (G&C), the CTO will distribute a scanned copy of checks and accompanying documentation received by clinical trial sponsoring agencies to the appropriate study team.  This is an automatic service and no action is required on the study team’s behalf.  A scanned copy of the check allows for easier reconciliation of study accounts.  Contact Jose M. Rodriguez at 804.628.2942 or email CTOAdmin@vcu.edu for more information.

  • Protocol Evaluation and Recruitment Planning
    The CTO provides training for study teams in evaluating proposed trials (overall study feasibility), as well as developing/refining research participant recruitment plans that engage our community and ensure compliance with regulations and best practices. Contact Tammy Anderson at 804.628.2959, or email CTOAdmin@vcu.edu for more information or to access this service.

  • Budget Development and Negotiation Services, including Fiscal Compliance Planning
    Review of the detailed study budget, including Medicare cost coverage analysis, start-up costs, appropriate reimbursement coverage of resource and procedure expenditures, effort allocation, review of space needs and incidental expenses, etc. To request budget development and negotiation services, contact Jose M. Rodriguez at 804.628.2942 or email CTOAdmin@vcu.edu.

  • Central Contact Point for Sponsor Placement of Clinical Trials at VCU
    The CTO is available to assist Sponsors with identifying Principal Investigators at VCU for all study indications to ensure the study is placed in a location acceptable to meet protocol requirements for enrollment. The CTO also advocates the establishment of master CDA and contract agreements with sponsors to shorten start-up .

  • Centralized Study Coordination Services
    This optional full service study coordination service is being piloted.  We look forward to defining and expanding these services to meet investigator needs while improving efficiency and decreasing departmental staffing cost. To request information about the use of centralized study coordination services, contact Susan Kornstein, MD or Tammy Anderson at 804.628.2959, or email CTOAdmin@vcu.edu.

  • Research Team Education and Training
    The VCU CTO offers comprehensive training options for research teams, including shadow opportunities for physicians interested in gaining clinical trial experience, certification-preparatory training for coordinators, and monthly lectures.  Please visit here to view training offered on an ongoing basis. Contact Susan Kornstein, MD or Tammy Anderson at 804.628.2959, or email CTOAdmin@vcu.edu. to learn more about this service.

  • Clinical Trials Outreach
    The VCU CTO has developed and currently maintains the first VCU comprehensive clinical trials website, listing all clinical trial opportunities at VCU.  In addition, we represent the VCU Center for Clinical and Translational Research by offering public seminars about clinical trial opportunities. To learn more, please visit www.clinicaltrials.vcu.edu and consider contacting the VCU CTO at 804-628-2961 or email CTOAdmin@vcu.edu.   The VCU CTO is eager to help community groups with identifying speakers who can provide information about clinical trials participation.

  • Quality Assurance
    Soon, the VCU CTO will begin incorporating ongoing quality assurance activities as part of our training program for research coordinators.  The vision is to utilize new coordinators to assist with the internal evaluation of study progress.  Not only will their knowledge be expanded, but our coordinators will be better prepared to ensure the highest quality data and work collaboratively with sponsors/monitors.