Prompt Report

Reporting for UTHSA IRB Studies

Submit UT Health San Antonio Prompt Report form
(REDCap Survey)

Need help deciding what to report?

• Decision Tree - Evaluating Departures
• Noncompliance definition
• Noncompliance Policy
• Deviations/Violations Policy
• Help Determining whether an AE is an Unanticipated problem
• Help Determining whether a non AE is an Unanticipated problem
• UPIRSO definition
• UADE definition
• Unanticipated Problems Involving Risk to Subjects
  or Others (UPIRSO) And Unanticipated Adverse Device Effects (UADE) Policy

Reporting for External IRB Studies

Submit to the IRB of record using their policies/procedures and process.

Copy IRBreliance@uthscsa.edu on the submission.

OCR will process the submission in REDCap for the
study team and send the study team an OCR review letter when complete.

Institutional Only Reporting

For UTHSA or External IRB (not requiring IRB
reporting):

Submit the local UT Health San Antonio Prompt
Report form for OCR Review.

Submit UT Health San Antonio Prompt Report form
(REDCap Survey)

Need help deciding what to report?

• Quick guide on sensitive issues which require prompt reporting to the institution
• Institutional Review Policy and Procedure