Clinical Research Regulatory Guidance


Office of Clinical Research

The Office of Clinical Research (OCR) provides regulatory guidance to Principal Investigators and their research personnel. Guidance is available for a host of regulatory concerns including:

  • IND/IDE requirements
  • Informed consent document requirements
  • IRB and FDA submission requirements
  • Adverse event and unanticipated problem reporting requirements
  • Regulatory binder maintenance requirements
  • CT.Gov Database Access and guidance

Request a new CT.gov account by contacting Lori Simon. You will affiliate with UTexasGalveston as the organization.


Federal Regulatory Guidance


Institutional Regulatory Guidance



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