Office of Clinical Research (OCR)

External IRB - Prompt Reporting


Submission of the prompt report form is only required for institutional items.  All non-institutional prompt reports should be submitted to the IRB of Record according to their policies and procedures.  If a report to the IRB of Record also includes institutional issues, copy on the submission to the IRB of Record. 


Use the UT Health San Antonio IRB Prompt Report form

Examples of institutional items requiring prompt reporting to OCR:

  • Personnel engaging in research activities without prior approval
  • Breach of confidentiality involving private, identifiable information
  • Any issues involving a HIPAA waiver/authorization
  • Any issues involving a conflict of interest (COI)
  • Any issues involving local safety committee approvals
  • Local research related deaths
  • Local FDA audits (email notification only)
  • Suspension or termination of site by Sponsor (email notification only)