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Clinical Trial Support Services (CTSS)

Request Clinical Research Services

The goal of Clinical Trial Support Services (CTSS) is to interact closely with UCSD investigators to provide quality services that support the planning, implementation, and completion of your clinical trials and clinical research studies.
We have an experienced team that can provide the following guidance, services, and support:

Regulatory Affairs

  • Determination of product classification
  • FDA IND/IDE/510K Guidance and Support
  • Protocol development assistance
  • Assistance with IND/IDE applications

Project Management – General and Study Specific

  • Coordination of multi-site research
  • Assist in preparation of annual reports
  • Clinical Trial Feasibility Assessment
  • Site Qualification Preparation and Support
  • Complete Research Account Forms in Velos
  • Study Start-up Coordination
  • Develop and maintain study metrics
  • Develop reports/tools to track enrollment
  • Create data capture processes/systems

Regulatory Support

  • Prepare IRB submissions including for non-UCSD IRBs – New applications, amendments, renewals, and reportable events
  • Informed Consent development
  • Coordination with Ancillary Committees – including Conflict of Interest, Human Exposure Review, and Institutional Biosafety
  • Collaboration with Office of Clinical Trial Agreements and Office of Coverage Analysis Administration via Kuali Research
  • Work with Sponsors and Clinical Research Organizations
  • Partner with ACTRI Research Coordinators

For more detailed information or to discuss how we can assist you, please contact us at actri-ctss@health.ucsd.edu

Our rates are available here.

To request our services, please submit the ACTRI Services Request form. You will be asked to complete and sign a Service Agreement prior to service initiation.