Office of the Vice President for Research - Research Administration

Clinical Trials Office

Welcome to the Clinical Trials Office, part of Research Administration.      

 

Clinical trials must be reviewed and cleared by the Clinical Trials Office (CTO) before the research application can be submitted to the IRB or OCR.

CTO pre-review is not applicable to human subjects research that does not meet the definition of a clinical trial.
CTO full-review applies to all studies in which patients are being compensated and/or a study has been identified as having a potential billing risk.
Clinical Trial Protocol Template Form
Use the template form for investigator initiated clinical trials
Learn more:
Frequently Asked Questions View Recorded Forums View the NIH Definition

Use the diagram below to guide you on which office you should submit first.

Clinical Trial Determination

 

 

Clinical Trial Review Process - UTHSA IRB is reviewing IRB

 

clinical trian review process

 

 

 

Clinical Trial Review Process - External IRB Requests

 

clinical trial review process

 

 

 

 

Mission

The Clinical Trials Office (CTO) serves as a central resource for investigators, study staff and departments involved in clinical trials research and for sponsors seeking to conduct clinical trials at UTHSCSA by:

  • Serving as the point of contact for questions or issues related to clinical trials
  • Assisting Principal Investigators with:
    • assessing the feasibility of conducting a clinical trial
    • developing a budget
    • reviewing and negotiating the budget section of contracts or other agreements with private industry and other entities
  • Developing and providing education and training on the Velos eResearch (Clinical Trials Management System)
  • Determine whether a study represents a billing risk, performing a coverage analysis and initiating the HSC’s tracking process to ensure accurate billing practices
  • Developing and implementing programs and initiatives, based on monitoring and assessment, to support compliance with applicable billing regulations
  • Administering the Participant Payment program, including the use of the ClinCard payment system