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The Cancer Center

Houston, Texas

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Cancer Center
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Clinical Trials Support Unit (CTSU)

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

The Clinical Trials Support Unit (CTSU) is a shared resource available to all members of the Dan L. Duncan Cancer Center (DLDCC) at Baylor College of Medicine (BCM)-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 can provide the following services to DLDCC members:

Regulatory and Administrative Assistance

Protocol Initiation

  • Protocol and consent form development
  • Internal regulatory submissions
  • 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 Study Manager™ 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).

How do I obtain services from the CTSU?

Contact Information:

Clinical Trials Support Unit
Dan L. Duncan Cancer Center
One Baylor Plaza, 450A Cullen
Houston, TX, 77030
ctsu-dldcc@bcm.edu
713-798-2878