1. 1 Clinical Research Management System (CRMS) IT Overview August 2011 Diana Gumas – Director of Clinical and Clinical Research IT

2. 2 CRMS Agenda Current Use Current Features Technology Highlights CRMS Strategic Objectives Q&A

3. 3 CRMS – Current Use Mandatory for all studies that could result in a patient bill Usage Statistics Reported Monthly – As of Aug 1, 2011: # StudiesCandidate Not CandidateConsentedEligibleEnrolled Not Eligible Total Participants Active1, 2811,7011,5921,26077027,5651,23134,119 Total4,6351,7791,7551,98384450,3312,18958,881

4. 4 CRMS – Features & Interfaces

5. 5 Technology Highlights Developed in partnership with Medical Decision Logics (MDLogix) Web-based application  Ruby on Rails front end  XSB Expert System for protocol / patient calendar  Microsoft SQL Server database 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

6. 6 CRMS Future Strategic Objectives 1. Facilitate Use by Affiliates & Clinical Research Network  Improved security for multi-site studies 2. Interface to new Epic EMR System  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. Expand interface to eIRB 4. Expand CRMS’ Utility for the Research Community  Additional Reports  Additional Interfaces  Sponsor billing via MDLogix Financial Module (?)

7. 7 Questions?