Clinical Research Management System
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Clinical Research Management System



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Clinical Research Management System  Clinical Research Management System Presentation Transcript

  • Layout of Presentation Background and Issues around Clinical Research What was done at UNC to help Clinical Research What recommendation is focus today Stakeholders for an administrative management system Specific goals for such a system Steps in evolution of such a system Vision of CRMS, version 1.0, 2.0 and 3.0 How CRMS adds value and What was specifically accomplished
  • Issues around Clinical Research Reduce the time it takes for laboratory discoveries to become treatments for patients. Engage communities in clinical research efforts. Critical need to train a new generation of clinical researchers. Tight budgets demand financial planning and management. Complex protocols require recruitment feasibility testing Other challenges with starting and conducting clinical trials. View slide
  • What was done at UNC to help clinical research NC TraCS Institute along with Office of Vice Chancellor of Research and Clinical Task Force came up with specific recommendations.  Changes to research support organizations, processes and tools.  Reorganization and expansion of the university’s Office of Clinical Trials.  Creation of UNC-NCRP (Network of Clinical Research Professionals).  Tools to help advertise studies for subject recruitment  Tools for managing research data. View slide
  • Our Focus for today We focus on tools for managing administrative tasks around research. Clinical Task force recommended a administrative research management system The goal was to streamline for researchers/teams the administration around research.
  • Stakeholders for an administrative management system NC TraCS(North Carolina Transactional and Clinical Sciences) Institute University Research Support offices- IRB, OCT,OSR,UNC Healthcare Research team  Principal Investigator  Research Coordinator  Budget Negotiators  Regulatory Specialist Department Administrators University Administrators Sponsors/Funders
  • Specific Goals for a new system Specifically address administrative barriers in executing research. Reduce duplicate data entry errors by using an automated online submission process. Provide budgeting tools and testing for feasibility of planned studies. Link campus research support offices through a common document repository. Facilitate decision-making. Speed the pre-study process that involves regulatory compliance. Improve both financial and administrative management
  • Steps in Evolution of the solution Home grown, custom built in collaboration with NC TraCS and ORIS. Leverage existing UNC campus infrastructure and research support tools. Understand pain points of research teams to develop a system to help them. Input from stakeholders. Based on SQL. Self serve model for research teams
  • Vision of CRMS
  • How it started-CRMS 1.0 The first version introduced in 2010. The main features were an online schedule of events A budget building tool with direct linkage to the hospital research fee schedule.  This enabled upfront calculation of the clinical costs required to complete the study. This first version also provided a tool to help research teams think through the subject recruitment process, estimating attrition rates, etc
  • What it does now-CRMS2.0 2nd version came out in December 2011. A major feature in this version was the ability to perform online submissions to OCT, IDS, and the Patient Accounts department. A dashboard, an auto feed from other online systems that tracks progress through various pre-study approvals through informative and visual swim lanes. An enhanced budget comparison tool to help look in detail at estimated costs versus a sponsor’s offer.
  • CRMS Dash Board Feature
  • Budget Comparison tool
  • The near future-CRMS 3.0 The next version CRMS 3.0 is slotted for deployment early 2013. It will include an integrated Clinical and Translational Research Center (CTRC) scheduler. Tracking of study visits and the associated expenses.
  • How CRMS adds value to Clinical Research at UNC? CRMS is one stop system for research teams for administrative management of clinical research. It acts as a  Budget tool  Recruitment tool  Feasibility tool  Online automated submission  Data Depository  Document repository  Links to other regulatory offices  Links to Hospital
  • What was achieved using CRMS CRMS currently offers  integration of isolated systems  automated paper processes  enrollment tracking,  study task management,  a transparent view of parallel processes,  and the ability to assess both financial and subject feasibility. CRMS is a UNC-built application whose capabilities will grow to include the entire study life cycle based on periodic feedback from users.
  • CRMS Many Thanks To: Ed Finerty- NC TraCS Project Manager Dr. Javed Mostafa Brian Moynihan Heather
  • CRMS Questions