Transcript The New Audit Paradigm

Clinical Research
Management System
(CRMS) IT Overview
August 2011
Diana Gumas – Director of Clinical and Clinical Research IT
1
CRMS Agenda
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Current Use
Current Features
Technology Highlights
CRMS Strategic Objectives
Q&A
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CRMS – Current Use
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Mandatory for all studies that could result in a patient bill
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Usage Statistics Reported Monthly – As of Aug 1, 2011:
#
Studies
Active
Total
Enrolled
Not
Eligible
Total
Participants
770
27,565
1,231
34,119
844
50,331
2,189
58,881
Candidate
Not
Candidate
Consented
Eligible
1, 281
1,701
1,592
1,260
4,635
1,779
1,755
1,983
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CRMS – Features & Interfaces
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Technology Highlights
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Developed in partnership with Medical Decision Logics (MDLogix)
Web-based application
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Ruby on Rails front end
 XSB Expert System for protocol / patient calendar
 Microsoft SQL Server database
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Hopkins-developed Reporting Server
Hopkins-developed Interfaces
Login via Johns Hopkins enterprise logins or Shibboleth
Servers hosted at Johns Hopkins Data Center
Hopkins IT staffing: 1 project manager and 1 database administrator
Leverage Central IT processes and support groups
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CRMS Future Strategic Objectives
1.
Facilitate Use by Affiliates & Clinical Research Network
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2.
Improved security for multi-site studies
Interface to new Epic EMR System
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Studies & Patients on Study to Epic
 Test results for study patients from Epic to CRMS Case Report Forms
 Easier ability to see future appointments
3.
4.
Expand interface to eIRB
Expand CRMS’ Utility for the Research Community
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Additional Reports
 Additional Interfaces
 Sponsor billing via MDLogix Financial Module (?)
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Questions?
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