Amendments, continuing reviews, and reportable new information (RNI) should be submitted in ERMS for all IRB and External IRB submissions. Prompt reports are no longer submitted to REDCap and should be submitted as a RNI in ERMS. Additional resources are located within ERMS:
ERMS IRB : Contains FAQ’s and User Guides.
ERMS IRB : Contains forms, templates, guidance documents and policies.
Generally applicable to funded covered under an existing agreement or contract with a funding entity, study , or a .
Changes to the study plan, , , study team, funding source or participant payment plan often may require modification of the existing agreement, MOU or contract.
Contact OSP for modifications to grant funded .
Contact CTO for modifications to industry sponsored .
Change to Velos submit the CTMS Change Request form to CTMS-Support@uthscsa.edu
Billing Industry Sponsors
UT Health SA Billing
OCR has investigator services to assist with responsibilities and monitoring activities. Contact the OCR for assistance: IRBreliance@uthscsa.edu; 210-567-8555
To assist with maintaining sponsor required records and documenation the following Sponsor Investigator Templates are available:
Monitoring - Onsite and
/CRO requests for must be documented.
How monitors access subject records depends on the institutional requirements were the study is being conducted.
A. at UTHealthSA
The PI or study team are responsible for arranging space, meeting schedule, access to study records.
For visits of more than three (3) consecutive days, study staff must ensure the monitor obtains a POI “person of interest” designation and criminal background check.
For more information see the Handbook of Operating Procedures (HOP) policy for obtaining a POI designation and criminal background check at .
B. Cancer Related : Access to Health Records (UTHealthSA EPIC) and Regulatory Documents (Complion)
Submit the "" form to the Mays Cancer Center Monitoring Administrator.
Questions regarding monitor access?
Mays Cancer Center - Mays-CC-Monitoring@uthscsa.edu
C. Non-Cancer Related : Access to Health Records (UTHealthSA EPIC)
Submit the "" form to the VPR CTO Monitoring Administrator.
Questions regarding monitor access to Epic?
Non-Cancer - VPRCTO@uthscsa.edu
Access to regulatory documents in Complion for noncancer studies are controlled by the study team.
D. Monitoring at University Health
Institutional Office of Compliance and Audits
The Institutional Office of Compliance and conducts periodic audits of IRB-approved conducted by UT Health San Antonio researchers. The goal is to achieve and maintain compliance with organizational policies and applicable laws, regulations, codes and guidance. Through periodic compliance reviews and other activities, the Compliance program evaluates and makes recommended improvements to increase compliance, when necessary.
Learn more about the Institutional Office of Compliance and Privacy Auditing Program
strives to create a climate that promotes adherence to high ethical standards without inhibiting the productivity and creativity of persons involved in research.
If you have concerns regarding Misconduct (i.e., , or ) you should contact the Research Integrity Officer (RIO), Babatunde Oyajobi, M.D., Ph.D., M.B.A. at oyajobi@uthscsa.edu .
Learn more about the
OIRB: IRB@uthscsa.edu; 210-567-8250 or IRBreliance@uthscsa.edu; 210-567-8555
