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THE SUE AND RALPH STERN CENTER FOR CANCER CLINICAL TRIALS AND RESEARCH

The UC Irvine Chao Family Comprehensive Cancer Center's Stern Center for Cancer Clinical Trials & Research is composed of three units:

1. Clinical Trials Unit (CTU)
2. Protocol Review & Monitoring Unit (PRM)
3. Regulatory Affairs Unit (RA)

All three units provide a centralized mechanism to support cancer clinical research and enhance the ability of CFCCC members to conduct clinical studies in compliance with all federal and state regulatory requirements. The Stern Center directly facilitates and supports the conduct of cancer treatment clinical trials for the entire lifecycle of a research study, which includes development and implementation support, as well as quality control functions. In addition to assistance specifically related to the planning and conduct of study protocols, Stern Center staff work closely with the School of Medicine and with Clinical Informatics to team-manage the clinical trials management system, OnCore, which houses protocol-specific data necessary for planning, reporting, and internal oversight, as well as tracking of activities, workloads and other key metrics.

Clinical Trials Unit (CTU)

The CTU provides central management and oversight assistance for coordinating and facilitating the study management needs for cancer clinical trials for the CFCCC. Clinical research coordinators (CRCs) are assigned to one of three teams who each handle several disease sites. Accordingly, CRCs work with multiple Disease-Oriented Teams (DOTs) to aid in the organization and operations of the clinical research enterprise and to provide workflow consistency to the Investigators conducting the trials. CTU CRCs assist Investigators by coordinating and executing the following clinical trial activities:

1. Conduct pre-qualification site initiation visits
2. Screen and assist with the consenting of research subjects
3. Educate subjects regarding the trial
4. Register subjects to clinical trials
5. Collect and record study-related data
6. Complete case report forms
7. Coordinate specimens and samples
8. Coordinate and oversee monitoring visits
9. Monitor and report serious adverse events
10. Facilitate subject follow-up

Protocol Review & Monitoring Unit (PRM)

The Protocol Review & Monitoring Unit provides centralized management and oversight assistance for our review committees for cancer clinical trials. PRM coordinators manage the following administrative activities:

1. Intake and pre review of all submissions
2. Query the Investigator for additional information, if necessary
3. Write minutes for all committee and DOT meetings
4. Write formal correspondence of stipulations to Investigators
5. Manage and coordinate all DOT, Protocol Review & Monitoring Committee (PRMC), and Data & Safety Monitoring Board (DSMB) meetings
6. Create OnCore data entry upon receipt of initial protocol submission
7. Manage clinical trial registration with Clinical Trial Reporting Program and clinicaltrials.gov

Regulatory Affairs (RA)

The Regulatory Affairs Unit provides centralized assistance for regulatory affairs for cancer clinical trials by management of the following activities:

1. Prepare and submit all Institutional Review Board (IRB) applications
2. Prepare and submit ancillary committee applications as needed (e.g. conflict of interest, radiation safety, biosafety, etc.)
3. Create consent forms
4. Create and maintain regulatory binders
5. Track and process external safety reports
6. Update OnCore as new studies obtain approval and activate, etc