Clinical Trials

The Office of Clinical Trials Management (OCTM) ensures the sites at which clinical research is performed comply with protocol and regulatory requirements and have the technical, operational, equipment, infrastructure, and staff required for the safe and compliant conduct of the clinical trial.

Activities and services of the OCTM include:

• Overseeing the UTSW Performance Site Approval Process
  • Ensuring the appropriate level of research credentialing for study personnel
  • Inventorying resources required for submitted protocols
  • Determining protocol feasibility for subject population and facility resources
  • Coordinating the review of resource utilization across departments/service lines/sites
• Facilitating Study Implementation and Conduct
  • Creating research study calendars and order sets
  • Assisting the Billing Office in correctly invoicing study activities
  • Facilitating communication and education across stakeholders involved in the conduct of the study
  • Reviewing serious adverse events (SAE) and unanticipated problems involving risks to subjects or others (UPIRSO) and creating remediation/prevention plans
  • Observing study phases, including study closeout
• Supporting Study Teams
  • Analyzing project-specific institutional resources
  • Reviewing feasibility of proposed interventions and evaluations
  • Providing guidance during the approval processes
  • Reviewing study budget

Need assistance? OCTM@UTSouthwestern.edu

The Clinical and Translational Science Award (CTSA) Program website at UT Southwestern provides information on a variety of clinical research services to investigators at each stage of their research including:

• Project Development
• Project Implementation
• Project Closeout and Dissemination

Aston Facilities are institutional resources, located on U7 and U9 floors of Aston Ambulatory Clinic Building on South Campus, supported and managed by Office of Clinical Research (OCR), which provide exam rooms, infusion chairs, DEXA scans, sample processing and storage facilities, procedure rooms, specialized research equipment rooms, and trained clinical research personnel to handle all aspects of a study.

The Clinical Research Unit (CRU) provides a controlled environment with trained research staff to support a broad range of research trials. All stages of investigators, from early to experienced, can access CRU services for patient-facing activities including examinations, consultations, infusions, and physiologic testing and can complement or expand the capacity and capabilities of their research teams with nurses, coordinators, pharmacists, and dietitians.

Clinical Research Units include:

• Surgery Research Administration
• Perot Foundation Neuroscience Translational Research Center
• Harold C. Simmons Comprehensive Cancer Center
• Internal Medicine Cardiology Research
• Division of Infectious Diseases and Geographic Medicine

The Investigational Drug Service (IDS) [within Pharmacy Services] provides full research pharmacy services to support clinical trials, including:

• Consulting services to develop pharmacy-related aspects of a protocol
• Secured location for drug storage and dispensing
• Interactive Voice Response System (IVRS)
• Subject randomization and blinding
• Protocol adherence, such as drug counseling and drug accountability
• Initial receipt and inventory of investigational agents
• Preparation and maintenance of drug accountability records
• Meetings with investigators and study monitors
• Preparation of protocol and drug information for pharmacy and study personnel
• Inventory control and accountability audits
• Ordering and maintaining drug stock
• Monitoring visits
• Storage and maintenance of returned drugs
• Reconciliation of drug accountability records, drug return, and maintenance of discontinued study pharmacy products upon study termination

The IDS is staffed by full-time research pharmacists and pharmacy technicians who are available to directly assist investigators. The IDS unit features a clean room, or a low-pollutant environment, for the storage and preparation of medication for clinical trials, where air quality is constantly controlled. An anteroom annex is connected to the clean room. The IDS also stores a limited number of study binders and is equipped to facilitate study monitor visits with advance notice.

Recruitment of clinical research volunteers can be one of the most challenging and time-consuming parts of a research study. The Research Recruitment Office works with study teams to develop and implement innovative recruitment strategies to recruit research volunteers.

Services

• Feasibility assessments
• Assistance developing a recruitment plan
• Cohort identification
• Assistance developing electronic health record-based feasibility queries
• Training on informatics tools for recruitment (e.g., i2b2, TriNetX, and SlicerDicer)
• Recruiting UTSW patients through MyChart
• Recruitment consultations during project startup, after funding, or to increase recruitment when traditional methods need supplementing

The Research Recruitment Office and Information Resources are developing a novel recruitment dashboard that will allow study teams to sort and prioritize potentially eligible participants based on clinical characteristics and/or when and where they will next be seen in the Health System.

Need assistance? ResearchRegistry@utsouthwestern.edu