Clinical Research Services (CRS) is a clinical trials office located within Holden Comprehensive Cancer Center.
Clinical Research Services has a portfolio of over 400 therapeutic cancer clinical trials.
Clinical Research Services (CRS) serves as a dedicated clinical trials office inside the cancer center. CRS supports all phases of interventional treatment human research.
Support includes the following:
- Clinical trial or protocol feasibility assessment: Involves obtaining protocol or synopsis to assess patient need and investigator-interest to open the study and operational feasibility of the trial. It also involves review of study by multidisciplinary oncology group leader endorsement.
- Regulatory management: Includes submission of IND, submission of study documents to either institutional review board (IRB) or central IRB, maintaining regulatory binders, etc.
- Clinical trial coordination: Includes patient recruitment, visit coordination, data collection and management, lab processing etc.
- Financial management Include budget development, invoicing and managing billing compliance
- Quality control and assurance activities
- Education for investigators and research staff
Clinical Research Services Resources
- Clinical Research Leadership
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- Mo Milhem, Associate Director of Clinical Research
- Muhammad Furqan, MD, Medical Director
- Jered Sieren, MPP, Assistant Director of Compliance and Informatics
- Mimi McKay, MPH, RN, Assistant Director of Clinical Coordination
- Mary Schall, BSN, RN, Quality Assurance Officer
- Cena Jones-Bitterman, MPH, Director of Compliance and Informatics
- Jessica Gallagher, MBA, Assistant Director of Finance
- Protocol and consent writing (for investigator-initiated trials)
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Interventional studies utilizing cancer center resources or enrolling cancer center patients require review and approval by the PRMC. PRMC submission typically requires a separate written protocol document which is reviewed by scientific, biostatistician, and Pharmacy and Therapeutics reviewers. Protocol development and navigation assistance are available within HCCC’s Clinical Research Services (CRS). To request protocol development assistance, please complete the survey.
- Monitoring for safety and compliance (for investigator-initiated trials)
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New research protocols involving cancer patients are reviewed by the Cancer Center’s Protocol Review and Monitoring Committee (PRMC). This committee is charged with the review of the scientific merit (hypothesis, objectives, design, sample size, biostatistics), prioritization with existing studies, and the adequacy of provisions for monitoring the safety of subjects via the data and safety monitoring plan.
The Data and Safety Monitoring Committee (DSMC) has a separate and distinct function from the PRMC and IRB. Its primary tasks are to:
- Review the eligibility of patients entering HCCC interventional investigator-initiated trials
- Assess subject safety by reviewing adverse and serious adverse event (AE/SAE) reports and ensure timely and appropriate reporting to oversight bodies,
- Monitor clinical trial activity as well as data integrity via routine monitoring
- Provide consultation and education to investigators regarding issues of subject safety and the development of acceptable data and safety monitoring plans
- Informatics Resources for Oncology Clinical Trials
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The Iowa Clinical Trials Management System (I-CTMS) is an enterprise-wide, software application system that supports the management of clinical trial data including protocol details, participants, data collection forms, calendars, financials, and billing. Resources are available to support your learning and engagement with the I-CTMS.