Dan L Duncan Comprehensive Cancer Center

Clinical Trials Support Unit

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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.

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CTSU Services

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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, and Internal Quality Assurance and Quality Control.

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Protocol Initiation

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Forms

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Internal Regulatory Submissions

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External Regulatory and Administrative Coordination

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

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  • 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
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General Regulatory Compliance

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

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  • 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
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Clinical Trials Informatics

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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
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Internal Quality Assurance and Quality Control

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Recommend improvements and changes to the QA/QC program as dictated by changes in regulations

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Training of CTSU personnel

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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
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CTSU Personnel

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CTSU Associate Director
Sarah McNees, Ph.D.
(713) 798-8810

CTSU Associate Director
Bambi Grilley, RPh
(832) 824-3893

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CTSU SOPs

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CTSU Standard Operating Procedures are available to BCM personnel on the BCM intranet (ECA log-in required).