Clinical Trials Resource Center (Regulatory Assistance)

Information and education on regulatory determinations regarding clinical investigations involving drugs and devices and ClinicalTrials.gov registration.

Our main website: https://www.uth.edu/ctrc/

Director and Contact person: Sujatha Sridhar, MBBS, MCE - clinicaltrials@uth.tmc.edu - 713-500-3622
Regulatory Specialists: Elizabeth Gendal, PhD; Shwetha Pazhoo, MS; Jessica Martinez, MPH. 

Investigators regularly identify achieving compliance with current regulatory requirements as one of the most challenging and frustrating aspects of clinical and translational research. Although these requirements are crucial to the protection of human subjects, difficulties with interpreting regulatory guidelines, the administrative time required for documentation, and the need to duplicate efforts across institutions present formidable challenges to the efficient translation of new knowledge to the clinic. 

The CTRC helps facilitate compliance with applicable regulatory requirements. CTRC staff help provide guidance for pre-IND application meetings with the FDA and consultations on requirements for IND/IDE applications and clinical trials registration. For more information contact us at clinicaltrials@uth.tmc.edu or visit https://www.uth.edu/ctrc/.