Data and Safety Monitoring Committee

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

DSMC Safety Officer:

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

Protocol Administrator:

Gary Rick, MSW
Location: 11510 PFP
Ph: 319-353-7846
Fax: 319-356-0471
gary-rick@uiowa.edu

Protocol Administrator:

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

  • screen all patients entering HCCC investigator-initiated, interventional trials for protocol-specified eligibility,
  • review accrual to 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 Gary Rick, Protocol Administrator at 319-353-7846 or Marilyn Rosenquist, DSMC 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
  • Ali Naderi, MD, Associate 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
  • Safety Officer: Marilyn Rosenquist, MS
  • Protocol Administrator: Gary Rick, MSW
  • Protocol Administrator: Cena Jones-Bitterman, MPP, CIP

DSMP Information