Clinical Research Regulatory Guidance
UPDATE: RESEARCH REGULATIONS AND COMPLIANCE IS NOW RESPONSIBLE FOR THE MANAGEMENT OF CLINICALTRIALS.GOV AT UTMB. PLEASE CONTACT VALERIE S. ROSEMOND AT VSROSEMO@UTMB.EDU
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
Request a new CT.gov account by contacting Valerie Rosemond. You will affiliate with UTexasGalveston as the organization.
Federal Regulatory Guidance
Federal Regulatory Guidance
Institutional Regulatory Guidance
Institutional Regulatory Guidance