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, and Internal Quality Assurance and Quality Control.
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
- 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
OnCore® Clinical Trials Management System
The Dan L Duncan Comprehensive Cancer Center employs OnCore, a full-featured enterprise-grade clinical trials management system (CTMS), as its central data collection and management platform.
To fulfill National Cancer Institute reporting requirements, all NCI-reportable cancer-related clinical trials and accruals at DLDCCC must be entered into OnCore.
OnCore is available to all DLDCCC Investigators and staff who have been adequately trained. Training classes are offered based on User specific roles, such as Regulatory Coordinator or Clinical Research Coordinator.
Please contact email@example.com or see below for additional information.
- Complete protocol management: Enter and track protocols, including reviews and approvals; monitor overall study activity such as accruals.
- Subject management: Study calendars to track a subject’s study progress; electronic data capture to collect and report subject data.
- Financial management: Complete financial management including coverage analysis, budget development, protocol milestones, invoicing, and payment tracking.
- Standardized reporting for NCI CCSG (e.g., DT3 and DT4) and NCI CTRP requirements.
- Robust pre-built reports to assist the study team with stud management, plus the ability to create customized reports.
- Can assist Investigators with preparing ClinicalTrials.gov reports.
What Kinds of Studies Can Be Managed in OnCore?
- Interventional trials of all phases
- Non-interventional and observational trials
- Single-center or multi-center trials, including management of trials at non-DLDCCC sites
- Non-randomized and randomized
How Much Does It Cost?
- Basic protocol creation and patient registration are free
- Full built trials which include calendars, eCRF’s, financials, etc., are invoiced on a sliding scale, depending on study funding
Minimum Data Entry Requirements
Please reference these documents, regarding the minimum data required to be entered into OnCore for DLDCCC reporting.