Data and Safety Monitoring Committee

Protocol Development and Monitoring, Administrative Office; 11510 PFP

DSMC Chair:

Daniel Berg, MD
Associate Professor, Hematology, Oncology and Blood & Marrow Transplantation
Director, Hematology and Medical Oncology Fellowship Program
Internal Medicine, C32-M GH
Ph: 319-353-7800
daniel-j-berg@uiowa.edu

DSMC Co-Chair:

To Be Named

Clinical Trials Research Manager:

Cena Jones-Bitterman, MPP, CIP
Location: 11510 PFP
Ph: 319-353-7846
Fax: 319-356-0471
cena-jones@uiowa.edu

Clinical Research Safety Officer:

Marilyn Rosenquist, MS
Location: 11510 PFP
Ph: 319-353-7899
Fax: 319-356-0471
marilyn-rosenquist@uiowa.edu

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 DSMPĀ  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 all patients entering HCCC 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 severe adverse events and ensure timely and appropriate reporting to oversight agencies (e.g. NCI, FDA),
  • review audits of selected high-risk trials, conducted by the safety officer, for data veracity, protocol compliance, and subject safety.

If you have any questions regarding the committee, contact Cena Jones-Bitterman, Clinical Trials Research Manager, at 319-353-7846 or Marilyn Rosenquist, Clinical Research Safety Officer, at 319-353-7899.

DSMC Members

  • Chair: Daniel Berg, MD, Associate Professor, Hematology, Oncology and Blood & Marrow Transplantation
  • Co-Chair: To Be Named
  • Brian Smith, PhD, Associate Professor, Biostatistics
  • Gideon Zamba, PhD, Associate Professor, Biostatistics
  • Susan Sorensen, PharmD, Clinical Pharmacy Specialist, College of Pharmacy
  • Shari Wood, PharmD, Clinical Pharmacy Specialist, College of Pharmacy
  • Taher Abu Hejleh, MBBS, Assistant Professor, Internal Medicine, Hematology, Oncology and Blood & Marrow Transplantation
  • Bryan Allen, MD, PhD, Assistant Professor, Radiation Oncology
  • William McGinnis, MD, Visiting Associate Professor Radiation Oncology
  • M. Sue O'Dorisio, MD, PhD, Professor Pediatrics, Hematology Oncology
  • Clinical Research Safety Officer: Marilyn Rosenquist, MS
  • Clinical Trials Research Manager: Cena Jones-Bitterman, MPP, CIP

DSMP Information