Take Action at UI Cancer Center
The UI Cancer Center Protocol Review and Monitoring System ensures that all studies performed at University of Illinois Cancer Center are safe, appropriate for the population we serve, and aligned with our research priorities.
Disease teams are expected components of the protocol review and monitoring system within NCI-designated cancer centers. Their function is to ensure cancer-related, hypothesis-driven, patient-oriented clinical research studies are vetted for:
- Appropriateness given the UI Cancer Center’s patient population and the current study portfolio (i.e., to ensure no overlapping studies)
- Clinical operational feasibility for activation and implementation
- Meeting UI Cancer Center’s clinical research priorities
Disease teams are also responsible for continuous evaluation of low accruing studies to determine the potential for closure.
All cancer-related, hypothesis-driven, patient-oriented clinical research studies conducted by the UI Cancer Center must be reviewed and approved by an appropriate disease team — or the CTO Medical Director, should an applicable disease team not be constituted. This must be completed prior to submission to the Protocol Review Committee (PRC) and Institutional Review Board (IRB) review.
To submit a study for disease team review, please email the study protocol to the disease team coordinator.
If you are unsure about which disease team is appropriate, email the study protocol to the CTO Regulatory Manager, Erin Vidra, at firstname.lastname@example.org.
Disease Team Resources
Protocol Review Committee (PRC) and OnCore Clinical Trials Management System
A comprehensive scientific review or determination of exemption from review is required for all new UI cancer-related protocols prior to IRB review.
The Cancer Center Protocol Review Committee (PRC), in cooperation with the UIC Office of the Vice Chancellor for Research and the Office for the Protection of Research Subjects, provides for the scientific review of all UI cancer-related protocols. Over 20 individuals from multiple oncology and health care disciplines serve as members of the committee. This diverse composition assures a multidisciplinary approach to scientific review.
The PRC meets every 2 weeks.
Contact the PRC
For more information about protocol review or OnCore, please contact the PRC Manager, Michelle Uriostigue Preza at email@example.com or 312-996-9146.
- PRC Policies and Procedures *Version 1.6 Date 8.29.20*
- PRC Submission Instructions – Initial Review
- PRC Data & Safety Monitoring Plan for Interventional Studies Form
- PRC Continuation Review PDF Form *Revised 5.15.2019*
- PRC Amendment Review PDF Form *Revised 2.25.2020*
- UI Cancer Center Protocol Review and Monitoring System (PRMS) Process
Submitting Your Study to the PRC
Studies are submitted to the PRC via the OnCore Clinical Trials Management System.
OnCore Clinical Trials Management System is an online software system to manage UI cancer related studies. This is intended to be a tool for all faculty doing cancer clinical research. It can be customized based on the needs of your research studies, and its functions include protocol management, subject management, data management, and financial management. Use of OnCore is required, at a minimum, for all cancer related study submission to the UI Cancer Center Protocol Review Committee (PRC), and to track participant enrollment and status for required NCI reporting and Data and Safety Monitoring Committee (DSMC) oversight.
Data Safety Monitoring Committee (DSMC)
Cancer Center Data Safety Monitoring Committee (DSMC), in cooperation with the UIC Office of the Vice Chancellor for Research and the Office for the Protection of Research Subjects, provides for the safety review of selective cancer-related protocols annually. Individuals from multiple oncology and health care disciplines serve as members of the committee. This diverse composition assures a multidisciplinary approach to safety review.
The DSMC provides review of UI investigator initiated cancer clinical trials at a frequency determined by the UI Cancer Center Protocol Review Committee (PRC). The frequency of trial DSMC review ranges from quarterly to annually, according to the level of risk assigned to the study by the PRC.
DSMC review specifically focuses on review of the safety monitoring plan of a protocol to ensure the safety of participants and the validity and integrity of the data. The DSMC meets monthly. Depending on the needs of the studies under the DSMC’s purview, additional ad hoc DSMC meetings may occur.
As of August 14, 2020, Version 7 of the Data Safety Monitoring Plan (DSMP) is effective and released.