Clinical Research Forum IT Roundtable

1
Clinical Research Management System

• Diana Gumas
• Director of Clinical and Clinical Research
  Information Systems

2
Background Build versus Buy

• In 2002 Dr. Mike Klag, then Vice Dean for
  Clinical Investigation, formed a Committee on
  Information Systems to Support Clinical
  Investigation (CISSCI)
• Faculty, administration and IT leaders
• Reviewed faculty needs
• Reviewed available vendors offerings
• Determined there were no existing products that
  would meet our clinical research and billing
  compliance needs

3
Background Choice of MDLogix

• Oncology Center renewal drawing near. Needed to
  improve clinical research information systems
• We were familiar with MDLogix work on several
  other projects including the National Autism
  network
• Spring of 2005 Dr. Mike Klag and Stephanie Reel
  recommended that the Oncology Center work with
  MDLogix for a solution
• Summer of 2006 MDLogix registry and study
  calendar prototype was impressive
• MDLogix solution recommended for development into
  a JHM-wide application by an outside consultant
  (Huron), Dr. Dan Ford, and Stephanie Reel.

4
Background Initial Project Governance

• Project Kickoff - July 2005
• Deployment Team
• Led by Sidney Kimmel Cancer Center Clinical
  Research Office
• Strong involvement/partnership with vendor
• Focused team of 9 expert users in weekly 3 hour
  meetings
• User-centered, iterative development
• Clinical Research Information Systems Project
  (CRISP) Committee
• Led by Ian Flinn, M.D., Ph.D.
• Composed of faculty
• Monthly Mtg to review progress approve work
  plan

5
Background Project Goal

• To deploy a comprehensive clinical research
  management system that integrates
• Research Programs
• Research Cores
• NCI (caBIG Standards)
• Critical requirement Interface with Existing
  Data Systems
• Johns Hopkins Authentication (JHED)
• Single Sign on (Siteminder)
• Electronic Patient Record (EPR)
• Pathology System (test results)
• Cancer Research Office protocol library
• eIRB

6
Background Readiness Assessment as of June 2007

• Successes
• Patient and Study Registry developed
• Integrated with Johns Hopkins Single Sign on
  system
• Test Interfaces to Electronic Patient Record and
  eIRB
• Challenges
• Lack strong project leadership
• Manage user requests for feature enhancements
• Interface with Johns Hopkins IT Department
• Non-development activities like Help Desk,
  Training, etc.
• Concerns about privacy and security of data
• Rollout beyond Oncology

7
Current State

• Director of Clinical Research IT put in place
  October 2007
• Reframe working relationship with MDLogix
• Adopt IT Best Practices
• Governance CISSCI Committee, Development Team
• CRMS Version 1.0 March 15, 2008
• Study and Participant Registry
• Interface to Electronic Patient Record
  (demographic data)
• Interface to eIRB (study data)
• Rolled out to 50 of Oncology, will be fully
  rolled out by April 30th
• Help Desk Support, well-supported servers, formal
  spec process
• Pilots on non-Oncology Studies (GI)

8
Current State

• CRMS Version 1.1 July 1, 2008
• Use on all new studies submitted to IRB after
  July 1st
• Billing compliance needs are driving adoption
• Will be concurrent process changes for billing
  compliance
• Use existing Research Coordinator Brown Bag
  Seminars to drive standardization of processes
• Software being developed now
• Support for Multi-Departments beyond Oncology
• Security Improvements
• Web training
• Use proven Support Pool model, Quick Reference
  Cards

9
Clinical Research IT Roadmap
Currently In Use
Key
Work In Progress
Future Functionality
10
Near-Term Future Plans

• Evaluate and Deploy Schema-Builder/Study Calendar
• Will receive software this month
• Critical for billing compliance
• Evaluate and Pilot the Forms Module
• Will receive software in June 2008
• Develop improvements for Prospective
  Reimbursement Analysis , Insurance Clearance, and
  Document Management
• Critical for billing compliance
• Specification effort underway
• Using Six Sigma techniques for process improvement