Cancer Center Clinical Trials Support Unit

• Associate Director for Clinical Research: Helen Heslop, M.D.
• Associate Director for Clinical Research: Martha Mims, M.D., Ph.D.

The Clinical Trials Support Unit is available to all members of the Dan L Duncan Comprehensive Cancer Center at Baylor College of Medicine affiliated hospitals and ambulatory care centers. The purpose of the CTSU is to promote high-quality, regulatory-compliant cancer clinical research by providing centralized oversight and management.

The CTSU offers all aspects of clinical research services to DLDCCC members, including:

• Protocol Initiation
• Protocol Administration
• General Regulatory Compliance
• Protocol Coordination
• Clinical Trials Informatics
• Internal Quality Assurance and Quality Control

Protocol Initiation

Forms

• Protocol and consent form development
• Protocol template
   

Internal Regulatory Submissions

• BCM IRB submissions (BRAIN)
• Affiliate research offices including MEDVAMC, Harris Health System, and Baylor St. Luke's Medical Center
• Protocol Review and Monitoring Committee
   

External Regulatory and Administrative Coordination

• Pharmaceutical sponsors
• NCI and/or other sponsors or regulatory agencies
• Other participating sites
   

Protocol Administration

• Create and maintain regulatory files
• Process and submit renewals and amendments to the IRB and other regulatory agencies
• Report adverse events to the IRB and other regulatory agencies
• Monitor study accrual
• Promote awareness of active clinical trials to DLDCCC Investigators and staff
• Distribute protocols to clinical treatment areas and study personnel
• Prepare for and participate in audits

General Regulatory Compliance

• Coordinate investigator registrations and credentialing (NCI Co-operative Groups)
• Ensure site regulatory compliance, e.g. investigational pharmacies, clinical laboratories
• Maintain and store research records

Protocol Coordination - Research Nurses / Coordinators

• Screen patients to identify possible participants
• Assist with informed consent process
• Ensure patient eligibility prior to enrollment
• Register patients
• Assure compliance with protocol-required tests and procedures
• Assist with preparation of study-specific order sets for chemotherapy
• Serve as liaison with the research pharmacy to ensure investigational drugs are ordered
• Ensure patient follow-up and continuity of care during study participation
• Completion and submission of case report forms in an accurate, timely manner
• Maintain ongoing communication with Investigators to ensure safe and compliant study conduct
• Evaluate and report adverse events per protocol guidelines

Clinical Trials Informatics

In collaboration with the Biostatistics and Informatics shared resource, the CTSU collects, organizes, and reports data to sponsors and regulatory agencies.

• Maintenance of electronic database of cancer related clinical protocols and subject registrations
• Training of personnel in the use of clinical trials software for cancer center reporting
• Development of study specific databases for data collection and reporting
• Reporting of clinical data as required by study sponsor

Internal Quality Assurance and Quality Control

• Recommend improvements and changes to the QA/QC program as dictated by changes in regulations
• Training of CTSU personnel
• Conduct internal audits of DLDCCC cancer clinical research
• Ensure integrity of research data collection
• Evaluate regulatory processes and compliance
• Develop corrective actions following audit responses