It is the mission of the Seton Research Enterprise to promote high quality clinical research and ensure good clinical practice in the conduct of research in our network.

Use the Seton Research Roadmap document as a guide to navigate conducting a research study at Seton. Use the Where to Get Help document to identify which department to contact for many research-related tasks.

All studies being conducted at Seton facilities and/or using Seton data will require the Principal Investigator to obtain site approval prior to study commencement using the Site Approval Tool. The tool will ask a series of questions and use branching logic to assist the Principal Investigator and Study Team in navigating through the approval process.

Site approval must be obtained PRIOR to conducting research activities and includes the following assessments:

  1. Research Privileges
  2. Human Subjects Protection
  3. Budget
  4. Contract
  5. Operational Impact

All required fields must be addressed and any required documents must be uploaded. Partially completed submissions may cause processing delays. Please expect 14 to 30 days for a final determination.

In order to minimize risk, Clinical Trial Agreements for Industry Sponsored Clinical Trials (e.g. drug or device) that take place in Seton facilities and involve Seton patients will be negotiated by Seton (Ascension), regardless of PI employment or affiliation status. Grant Agreements for PIs with UT Faculty appointments will be administered by Sponsored Projects Awards Administration.

Begin this process once all study-related documents are obtained from the Sponsor (or created, for Investigator-initiated studies). Be sure to have all relevant materials available for reference and uploading before you begin. Final Site Approval is contingent on IRB Approval and may be initiated in parallel.

Questions?

Email the Site Approval Team: siteapproval@seton.org