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Dan L. Duncan Cancer Center

Houston, Texas

BCM has 25 departments and more than 90 research and patient-care centers.
Dan L. Duncan Cancer Center
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Clinical Trials Support Unit

Martha Mims, M.D., Ph.D., Director

The Clinical Trials Support Unit is a shared resource available to all members of the Dan L. Duncan 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.

CTSU Services

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

Protocol Initiation

  • Protocol and consent form development
  • Protocol template
  • Internal regulatory submissions
    - BCM IRB submissions (BRAIN)
    - Affiliate research offices: MEDVAMC, BTH/Harris Health System, SLEH, TMH
    - 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 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 DLDCC Investigators and staff

    • Distribute protocols to clinical treatment areas and study personnel

    • Prepare for and participate in audits

    General Regulatory Compliance

    • Investigator registrations and credentialing (NCI, cooperative groups, affiliate hospitals)

    • Site regulatory compliance, e.g. investigational pharmacies, clinical laboratories

    • Storage of 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 patient

    • 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

    • Accurate, timely and complete capture of study-required data

    • Completion of case report forms

    • 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 Data Management shared resource, the CTSU collects, organizes, and reports data to sponsors and regulatory agencies.

  • Maintenance of electronic database of cancer related clinical protocols and patient registry
  • 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

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

Standard Operating Procedures

  • CTSU SOPs are available to BCM personnel on the BCM intranet (ECA log-in required).

Personnel and Contact Information

To request additional information, investigators may contact the CTSU at:

General Information

CTSU Director
Martha Mims, M.D., Ph.D.

CTSU Associate Director, Pediatric/CCGT
Bambi Grilley, R.Ph.

CTSU Associate Director, Adult
Sarah McNees, Ph.D.

CTSU Manager, Pediatric/CCGT
Bridget Medina

Clinical Trials Available

View a list of current DLDCC available clinical trials.

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