Clinical Research

Vanderbilt University Medical Center has a long history of excellence in conducting clinical research and clinical trials. For faculty members within the Division of Hematology and Oncology, the Vanderbilt-Ingram Cancer Center offers several resources to assist investigators in developing, activating and completing scientifically meritorious clinical trials in an efficient, cost-effective and technically sound manner. Below are a list and short summary of available resources.

  • The roles and responsibilities of the IRB include:

    • Assures compliance with the Federalwide Assurance (FWA)

    • Assures Vanderbilt University and Vanderbilt University Medical Center’s policies and procedures are effectively applied in compliance with state and federal laws and regulations, the FWA, OHRP, FDA, NIH, OCR, and any other applicable federal agency.

    • Provides interpretation and application of federal regulations.

    • Develops, implements, and interprets HRPP policies and procedures.

    • Takes action on non-compliance according to HRPP policies and procedures, as necessary.

    • Ensures adequate resource allocation and annual review of resources.

    • Actively participates in the IRB Optimization Committee.

    • Supports and facilitates the IRB process.

    • Maintains ongoing educational programs (e.g., News You Can Use, Research Matters, IRB Essentials, etc.) for Investigators, key study personnel, IRB Committee members, and HRPP staff.

    • Participates in mandatory training, as well as other ongoing educational activities to keep abreast of current events.

    • Provides regular training and education to IRB Committee members and keeps the Committees abreast of current events.

    • Mentors and trains new staff as needed, including HRPP staff, Investigators, and key study personnel on human subject protections and the IRB process. Provides 3 and 6-month evaluations to the HRPP staff.

    • Performs and documents quality assurance activities to assure compliance.

    • Provides internal and external monitoring, which is designed to assess compliance and safety in human subjects research.

    • Performs directed audits and random compliance reviews. Formulates and implements, as needed, recommendations for the Investigator and his/her staff.

    Contact: (615) 322-2918

  • The Clinical Trials Office (CTO) in the Vanderbilt-Ingram Cancer Center provides services to assist cancer center investigators in developing, activating and completing scientifically meritorious clinical trials in an efficient, cost-effective and technically sound manner. The CTO provides services to assist investigators with:

    • Protocol development
    • Regulatory compliance
    • Study start-up
    • Data management
    • Research nursing
    • Auditing
    • Patient accrual through the V-ISTA program

    Manager: Catherine Gregor, M.B.A., CCRC, CCRP |

  • The Scientific Review Committee (SRC) ensures that all cancer clinical trials conducted under the auspices of the Vanderbilt-Ingram Cancer Center meet peer-reviewed standards of scientific design, including appropriate scientific rationale, specific aims, study endpoints, biostatistical analysis, and adequate ability to accrue patients. These criteria ensure that the study is conducted in accordance with the scientific principles and integrity maintained by the Vanderbilt-Ingram Cancer Center, that the scientific aims of the study can reasonably be met, and that cancer center resources used to support clinical investigation are appropriately and wisely used.

    Chair: Marta Crispens, MD |

  • The Data and Safety Monitoring Committee (DSMC) provides centralized review of adverse drug events and safety issues for investigator-initiated trials and NCI-funded trials. The DSMC also audits institutional trials to ensure that the conduct and integrity of the study are of the highest quality and that all trials adhere to the regulatory requirements. All therapeutic and device investigator-initiated and NIH/NCI-funded clinical trials are monitored for scientific progress, accrual, data completeness, and regulatory compliance.

    The purpose of the DSMC is to ensure:

    • The safety of clinical trial participants
    • The validity and integrity of data for all NIH-supported and investigator-initiated clinical trials
    • Compliance with NIH policy on data and safety monitoring for NIH-supported clinical trials

    Chair: Ingrid Mayer, MD, MSCI |

  • Innovative Translational Research Shared Resource (ITR) at the Vanderbilt-Ingram Cancer Center partners with oncologists and researchers to guide, manage, and facilitate pre-clinical and clinical trial laboratory discoveries. The ITR offers comprehensive support managing collaborations, workflow, budget, and timelines to achieve research goals in a timely manner.


    Lab Manager : Jamye O'Neal, BS, MLI  |
    Director:  Kim Dahlman, PhD |