The Perot Foundation Neuroscience Translational Research Center (PNTRC), part of the O’Donnell Brain Institute, was established in 2012 as a comprehensive translational research center working with bench and clinical researchers. The PNTRC participates in clinical trials that deliver novel drug and device discoveries to patients. The dedicated work of our team combines the expertise and successes of bench researchers with clinical trialists to maximize the outcomes for adult and pediatric patients who choose to participate in clinical research trials.
The PNTRC is comprised of a University Core, the Neuroscience Clinical Research Unit (NCRU), in addition to a compliance and quality assurance program, regulatory services, contracting and budgeting support, and data analytics. We provide services at UT Southwestern Medical Center and its affiliated hospitals.
Our experienced team assists with feasibility questionnaire completion, managing new study planning logistics, and providing ongoing coordinator support through the completion of your project. Our specialized services include a dedicated regulatory specialist who manages IRB submissions and Performance Site Reviews. Our Compliance Manager helps researchers navigate to the required trainings required to participate in clinical research, assists with research credentialing, performs quality assurance audits, and assists the NCRU team with preparation for HRPP and sponsor audits.
The PNTRC currently provides services for clinical research projects in the Departments of Neurosurgery, Pediatrics, Physical Medicine and Rehabilitation, and Radiology.
Neuroscience Clinical Research Unit
The Neuroscience Clinical Research unit (NCRU) is a University Core of skilled and experienced clinical research staff who specialize in research performed in the neurosciences for adult and pediatric patients. This experienced team performs study startup tasks, organization and planning of study visits, data collection and entry, phlebotomy, ECGs, neuropsychological assessments, and more. The NCRU employs licensed registered nurses who perform clinical procedures that include intravenous placements, injections, and administer investigational products. We manage studies conducted at UT Southwestern outpatient clinics and the university hospitals as well as Parkland and Children's Health. To utilize our NCRU services, a survey request in RedCAP is required and an active iLab Organizer (corefacilities.org) account is necessary before services may begin.
- Several Certified Clinical Research Coordinator (CCRC) and Certified Clinical Research Professional (CCRP) credentialed research nurses and study coordinators, including some board members of local chapters.
- Many team members with more than a decade of employment history at UTSW and Children’s Health.
- Our team are members of the following organizations: Association of Clinical Research Professionals, Society of Clinical Research Associates, Association of Child Neurology Nurses, American Heart Association, and disease specific organizations.
- Several of our team members serve on steering committees with institutional research teams around campus.
- Contracts Management: creates, develops, and plans the implementation of research projects by providing contractual support. Services include budget creation and negotiations for clinical trials; submission of Clinical Trial Coverage Analyses, financial feasibility surveys, direct correspondence with sponsors, billing for services to sponsors, and submissions to Sponsored Programs and Contracts Management offices.
- Regulatory Services: dedicated resource to assist investigators with regulatory preparation and IRB submissions for new studies, as well as ongoing support that includes modifications to the protocol and annual reviews.
Compliance and Quality Program: oversees the onboarding and research education for new staff, ensures initial and ongoing competencies of staff training requirements, assists with audit preparations and study monitor visits, ensures compliance with study protocols, as well as institutional, state, and federal guidelines.