All research protocols involving outpatient or inpatient hospital procedures require approval from the St. Louis University Hospital Research Compliance Office prior to study initiation.  This process is designed to facilitate compliance with state and federal regulations as they pertain to research conduct and clinical research billing. The Principal Investigator is required to follow the guidelines below when submitting a new study protocol:  

I.  Hospital Approval Requirements:  

Complete a Research Compliance Application Form.    Once the application has been completed, the PI/Study Coordinator submits this document along with the following documents to the Research Compliance Office.   Documents should be submitted concurrently with IRB submission:  

a.     A completed Research Compliance Application form

b.     Treatment calendar (or schedule of research events)

c.     IRB application/protocol and consent form

d.     Sponsor’s protocol (for government and industry sponsored studies only)

e.     List of CPT codes for research procedures

f.      Draft of clinical trial agreement (for government and industry sponsored studies only)   

Upon receipt of the above documents, the request for approval for performance of clinical research will undergo review by the Saint Louis University Hospital Research Compliance Office and the Research Review Committee (RRC).   

Final study approval requires IRB full approval.  Please note: It is the responsibility of study investigators to submit the IRB full approval letter, stamped consent form and final draft of clinical trial agreement to the Research Compliance Office upon receipt. The Principal Investigator will receive electronic and written notification of study approval.  

II. Post-Approval Requirements:  

The submission of a Research Encounter Ticket is required for all patients placed on study:                  

For Inpatients:   The PI or Study Coordinator must submit a Research Encounter Ticket to the                 Research Compliance Office within 24 hours of placing a patient on protocol.                    

For Outpatients:  The patient is required to present a Research Encounter Ticket to the hospital registration area and email a copy to the Research Compliance Office.     

Research Encounter Tickets should be emailed to:  sluh.research@tenethealth.com  

You may access the Research Encounter Ticket here. 

Instructions on how to complete the ticket can be downloaded here.   

Contact Information:  

Saint Louis University Hospital

Research Compliance Office

West Pavilion, Ste 100

3635 Vista Ave.

St. Louis, MO  63110

(314) 577-8113 (office)