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
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.
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