Transcript The New Audit Paradigm

Learn @ Lunch – Clinical Research Systems
Diana Gumas – IT Director
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What is clinical research?
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SO, HOW LONG DOES THIS ALL TAKE?
17 YEARS!
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WE WANT TO CHANGE THAT,
AND WE CAN!
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Clinical Research Management System
(CRMS)
•
•
•
1,054 Users
958 Active Studies (3330 Total)
16,076 Active Participants (46,216 Total)
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One Stop Shop for Study Management!
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Study Registry
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Participant Registry
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Eligibility Checklist
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Document Library
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Reports
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Automated reporting to IRB
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CRMS– Electronic Case Report Forms
Background: Case Report Forms (CRF) are used to capture study
data.
Today: Paper CRFs OR researchers invest precious study $$ in
individual electronic solutions.
Tomorrow: Electronic library of reusable CRFs which
automatically feed a database which can easily be queried and
turned into reports.
Status: Enterprise deployment starting October 1, 2010.
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CRMS Reports
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CRMS Sponsor Billing
Evaluating a CRMS add-on to facilitate sponsor billing
• Interface to patient calendar
• Reconciles initial budget against actual study costs
• Determine cost/subject
• Project costs based on anticipated accrual
• Print invoice to send to sponsor
• Track payment
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EPR2020 Data for Researchers
4.2M Patients, 23.4M Visits
12.3M Documents, 6.8M Radiology Reports
25.6M Lab Results
1.5M Problems, 2.2M Medications, 140K Allergies
Planned in 2010
• Bayview & JHCP data
• ICD9 diagnosis codes and CPT charges
Future
• Death Registry
• Blood Product Data for Transfusions
• Eclipsys SCM Order data
• HMED (ED), ORMIS, eADR/Medivision
From
EPR
Today
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Cohort Discovery using EPR2020
A JHM investigator wants to find and enroll diabetic patients
aged 45-65 years
with hemoglobin A1C between 7 and 9%
serum creatinine < 2 mg/dl
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My Participant’s Lab Data
Reliable.
Driven by the CRMS Participant Registry.
Exportable.
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Patient Safety
A patient arrives in the emergency department,
incoherent and with difficulty breathing.
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Lab Value Alert
A renal research team wants to know whenever one
of its participants has serum K+ >5.5.
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Tracking Specimens
Knowledge acceleration
Successful pilots by 3
JHM tissue repositories
Securing funding for
enterprise deployment
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https://cabig.nci.nih.gov/tools/catissuesuite
For more information
about Clinical Research @ Hopkins
http://www.clinicaltrials.gov/
http://trials.johnshopkins.edu/
http://www.hopkinsmedicine.org/quality/patients/clinical_trials/
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