Office of Clinical Research (OCR)

Training Requirements and Opportunities

Note: See also Scope of Practice
 
Required Training:
for all individuals conducting human subject research
Human Subjects Training
  COI training
 
REQUIRED for all personnel conducting NIH sponsored Clinical Trials and highly recommended for all personnel conducting Clinical Trials: 
GCP training
 
Additional Training, as applicable:
Sponsor Investigator Training
IATA Training
Participant Payment Training
 
 
Recommended Training:
for researchers conducting clinical trials requiring Good Clinical Practice training
AND
for all NEW investigators and research coordinators
ACRP Training

 

Please contact OCR (210-567-8555 or OCRMail@uthscsa.edu) to schedule individual training in any of the following areas:

  • Overview of Sponsor-Investigator (IND/IDE holder) regulatory responsibility
  • Overview of record keeping requirements for Sponsor-Investigators
  • Review of reporting requirements including safety reports and annual report
  • Review of federal regulations governing IND/IDE studies providing tools/checklists to ensure regulatory compliance
  • IND and IDE applicability assessments
  • Overview of the FDA IND/IDE application process