practicum presentation

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

2. 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

3. 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.

4. 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.

5. 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.

6. 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

7. 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

8. 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

9. Vision of CRMS

10. 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

11. 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.

12. CRMS Dash Board Feature

13. Budget Comparison tool

14. 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.

15. 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

16. 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.

17. CRMS
 Many Thanks To:
 Ed Finerty- NC TraCS Project Manager
 Dr. Javed Mostafa
 Brian Moynihan
 Heather

18. CRMS
 Questions