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Clinical Trials Resource Center

Regulatory Assistance

Information and education on FDA applications and federal, state and local regulations

Director and Contact person: Sujatha Sridhar, MBBS, MCE clinicaltrials@uth.tmc.edu 713-500-3622
Regulatory Specialists: Catrina Coverdale, BS, CCRC; Liz Gendal, PhD

The goal of the Clinical Trials Resource Center (CTRC) is to promote excellence in clinical trial management through education and to help facilitate effective and timely clinical trial initiation by improving institutional processes and developing clinical trial management tools.

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. These burdens can be so overwhelming that they inhibit potential researchers from proposing studies with human subjects.

The CTRC helps facilitate compliance and insure that all CCTS activity meets applicable internal and external regulatory requirements. Through its expertise in academic and pharmaceutical research, the legal aspects of clinical studies, and administrative systems, the CTRC advises and educates investigators on the regulatory aspects of clinical and translational research.

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/