REGULATORY KNOWLEDGE AND SUPPORT

Director:   Sujatha Sridhar
Co-Director:  Madelene J Ottosen, RN, MSN, CCRC
Validation Manager: Patrick Curfman
Contact person:  Gena Monroe, Sr. Regulatory Affairs Specialist (713-500-7903-Gena.Monroe@uth.tmc.edu)

The goal of the Regulatory Knowledge and Support Component is to facilitate compliance and insure that all CCTS activity meets applicable internal and external regulatory requirements.

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 goal of the Regulatory Knowledge and Support Component is to 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 Regulatory Knowledge and Support Component advises and educates investigators on the regulatory aspects of clinical and translational research.  Training classes and individual consultations are offered, including guidance for pre-IND application meetings with the FDA and consultations on requirements for IND/IDE applications.  The Regulatory Knowledge and Support Component also offers various training courses for investigators and study teams of all levels. Please contact Madelene Ottosen, RN madelene.j.ottosen@uth.tmc.edu or Gena Monroe Gena.Monroe@uth.tmc.edu for details. 

Organizational Chart for Regulatory Knowledge and Support Unit