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 OCRmail@uthscsa.edu on the submission to the IRB of Record. 

 

Download 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)