Clinical Research Management System- CRMS TAR HEEL SOLUTION TO RESEARCH ADMINISTRATION MANAGEMENT PRACTICUM PRESENTATION ANSHU J GUPTA FALL 2012
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.
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.
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
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.
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