Office of the Institutional Review Board

New Clinical Trial Submission Process

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

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 process


Clinical Trial Review Process - UTHSA IRB is reviewing IRB

 

clinical trian review process

 

 

 

Clinical Trial Review Process - External IRB Requests

 

clinical trial review process