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 鈥減erson of interest鈥 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 亚洲无码 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