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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/