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University of Colorado Cancer Center

University of Colorado Cancer Center, A National Cancer Institute-designated Comprehensive Cancer Center
 

Data and Safety Monitoring Committee

The University of Colorado Cancer Center’s Data and Safety Monitoring Plans help ensure safety and ethical treatment of all human subjects participating in research and verify that all collected data is accurate, complete, valid and has integrity.

The CU Cancer Center Data and Safety Monitoring Committee (DSMC):

  • Oversees all aspects of QA/DSM within the Clinical Investigations Shared Resource
  • Reports to the CU Cancer Center Executive Committee and the Colorado Multiple Institutional Review Board (COMIRB)
  • Oversees reporting of adverse events and SAEs to sponsors and federal agencies such as NCI AdEERs.
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    The DSM Committee identifies, develops and offers a variety of instructional activities to CISR staff, Principal Investigators and Co-Investigators to improve knowledge of and compliance with clinical trials management standards.

    Collaboration

    CISR collaborates with COMIRB, CU Denver Associate Vice Chancellor for Compliance, the School of Medicine Clinical Trials Advisory Committee, University of Colorado Hospital Research Review Committee and others to make the clinical trials process more efficient and accurate.

    Committee Members

    Name Titile Expertise
    Jennifer Diamond, MD Chair Medical Oncology
    Astrid Elder, PhD Senior Regulatory Analyst COMIRB
    Anthony Elias, MD Medical Oncology
    Christine Fisher, MD Radiation Oncology
    Lia Gore, MD Pediatric Oncology
    Colleen Kellackey, RN Clinical Operations Manager CISR
    Elaine Lam, MD Medical Oncology
    Stephen Leong, MD Medical Oncology
    Jan Lettieri, RN, BSN DSMC Manager DSM
    Adam Poust, PharmD Investigational Pharmacy
    Zung Vu Tran, PhD Biostatistics
    Amanda Vyn, RN, BSN, MPH DSMC Monitor DSM