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Learn @ Lunch – Clinical Research Systems. Diana Gumas – IT Director. What is clinical research?. So, how long does this all take?. 17 Years!. We want to change that, and we can!. Clinical Research Management System (CRMS). 1,054 Users 958 Active Studies (3330 Total) - PowerPoint PPT Presentation
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Learn @ Lunch – Clinical Research Systems
Diana Gumas – IT Director
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What is clinical research?
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17 YEARS!
SO, HOW LONG DOES THIS ALL TAKE?
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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)
• One Stop Shop for Study Management!– Study Registry– Participant Registry– Eligibility Checklist– Document Library– Reports– 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 Visits12.3M Documents, 6.8M Radiology Reports25.6M Lab Results1.5M Problems, 2.2M Medications, 140K Allergies
Planned in 2010• Bayview & JHCP data• ICD9 diagnosis codes and CPT chargesFuture• Death Registry• Blood Product Data for Transfusions• Eclipsys SCM Order data• HMED (ED), ORMIS, eADR/Medivision
FromEPR
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
https://cabig.nci.nih.gov/tools/catissuesuite
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For more information about Clinical Research @ Hopkins
http://www.clinicaltrials.gov/ http://trials.johnshopkins.edu/ http://www.hopkinsmedicine.org/quality/patients/clinical_trials/