Operational Services
UT Southwestern provides robust operational services to comprehensively support clinical research across our institution.
Protocol and Grant Support
Clinical departments employ grant specialists to support research teams with the goal of improving quality and reducing the time from study concept to final protocol for investigator-initiated clinical research. Supporting services include:
Human Research Protection Program (HRPP)
The Human Research Protection Program (HRPP) Department houses the Institutional Review Board (IRB), Regulatory Support Office (RSO), and Quality Assurance and Monitoring (QAM) Offices.
- UTSW IRBs are charged with the responsibility of reviewing and approving, prior to initiation, research involving human participants. This review is primarily concerned with ensuring the rights, safety, welfare, and privacy of human participants are protected.
- The RSO supports investigators with meeting ClinicalTrials.gov requirements. The RSO also supports IND or IDE holders (Sponsor Investigators) in meeting their obligations for the FDA. For both, the RSO assists with initiation/registration, updates, annual reports, and final closure/results reporting (as applicable).
- The QAM assists investigators before, during, and after external audits (e.g., FDA inspections), developing and carrying out monitoring plans to meet FDA and/or NIH requirements, and conducting monitoring of individual research studies (both for-cause and not-for-cause).
Sponsored Programs Administration (SPA)
Sponsored Programs Administration (SPA) guides researchers through the funding award life-cycle process by assisting with contract negotiations, budget preparation, study activation and management, fiscal management and reconciliation, study closeout, and filing appropriate documents with study sponsors.
Office of Research Development
The Office of Research Development leads UT Southwestern's efforts to increase the number of large, program-project-style grant applications to federal and national funding sources, facilitates the development of large, complex research grant applications, and advises faculty on suitability and approach to large, multidisciplinary funding opportunities that capitalize on existing strengths and expertise. For more information about the Office of Research Development, wendy.pechero@utsouthwestern.edu Wendy Pechero.
Office for Technology Development
The Office for Technology Development protects, enhances, and advances UT Southwestern innovations to maximize benefits for community health and well-being by advancing research discoveries into innovative technologies for commercial application and cultivating collaborative relationships with our faculty, researchers, and external partners.