The Committee’s Charge

All principal investigators of cancer clinical trials at the Holden Comprehensive Cancer Center are required to include a Data and Safety Monitoring Plan (DSMP) in their institutional research protocols.

The DSMP must be prospectively reviewed and approved by the Data and Safety Monitoring Committee prior to enrolling patients on the trial.

The Data and Safety Monitoring Committee has a separate and distinct function from the PRMC or IRB. Its primary tasks are to:

• review patients entering Holden investigator-initiated, interventional trials for protocol-specified eligibility,
• review adverse events on these trials, make recommendations for closure to the PRMC,
• assess safety by reviewing all serious adverse events and ensure timely and appropriate reporting to oversight agencies (e.g., NCI, FDA),
• monitor trials for data veracity, protocol compliance, and subject safety.

If you have any questions regarding the committee, contact Cena Jones-Bitterman, Assistant Director, Compliance and Informatics, at 1-319-353-4596 or Jill Wegmann, Protocol Development and Monitoring Manager, at 1‐319‐335‐3013.

DSMC Members

• Chair: Carryn Anderson, MD, Clinical Professor, Radiation Oncology
• Co-Chair: Naomi Fei, MD, MS, Clinical Assistant Professor, Hematology, Oncology and Stem Cell Transplant and Cellular Therapy Program
• Douglas E. Laux, MD, Clinical Associate Professor, Hematology, Oncology and Stem Cell Transplant and Cellular Therapy Program
• Brian Smith, PhD, Professor, Biostatistics
• Gideon Zamba, PhD, Professor, Biostatistics
• Zachary Less, PharmD, Clinical Pharmacy Specialist, College of Pharmacy
• Daniel Vaena, MD, Visiting Professor, Hematology Oncology
• Christopher Strouse, MD, Clinical Assistant Professor, Hematology, Oncology and Stem Cell Transplant and Cellular Therapy Program
• Kellie Bodeker, MSHS, PhD; Associate Director, Theranostics Research
• Melanie Frees, BSN, Clinical Research Specialist
• Sneha Phadke, DO, MPH, Clinical Associate Professor, Hematology, Oncology and Stem Cell Transplant and Cellular Therapy Program
• Protocol Development and Monitoring Manager: Jill Wegmann, RN, BSN, CCRP
• Compliance Specialist: Jeri Sieren, RN
• Compliance Specialist: Janan Geick, RN, BSN
• Senior Compliance Coordinator: Amanda Farmer, BS
• Senior Application Developer: Jill Kuennen, MA
• Assistant Director, Compliance and Informatics: Cena Jones-Bitterman, MPP, CIP, CCRP