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:
Gerald Clamon, MD
Professor Internal Medicine
5970 JPP
Ph: 319-356-1932
gerald-clamon@uiowa.edu
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
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 (and the PRMC) 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: Gerald Clamon, MD, Professor, Internal Medicine
- Thomas Carlisle, MD, PhD, Clinical Associate Professor
- Brian Smith, PhD, Assistant Professor, Biostatistics
- Gideon Zamba, PhD, Assistant Professor, Biostatistics
- Protocol Administrator: Gary Rick, MSW
- Safety Officer: Marilyn Rosenquist, MS
- Sarah Holstein, MD, Ph.D., Assistant Professor
- Susan Sorensen, Pharm.D. Clinical Pharmacy Specialist
- Shari Wood, Pharm.D. Clinical Pharmacy Specialist
- Taher Abu Hejleh, MBBS, Assistant Professor
DSMP Forms and Information