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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)

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Learn @ Lunch – Clinical Research Systems


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    1. Learn @ Lunch – Clinical Research Systems Diana Gumas – IT Director

    2. What is clinical research?

    3. So, how long does this all take? 17 Years!

    4. We want to change that, and we can!

    5. 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

    6. 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. CRMS– Electronic Case Report Forms

    7. CRMS Reports

    8. 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

    9. EPR2020 Data for Researchers From EPR Today 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

    10. 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

    11. My Participant’s Lab Data • Reliable. Driven by the CRMS Participant Registry. Exportable.

    12. Patient Safety A patient arrives in the emergency department, incoherent and with difficulty breathing.

    13. Lab Value Alert A renal research team wants to know whenever one of its participants has serum K+ >5.5.

    14. Tracking Specimens Knowledge acceleration Successful pilots by 3 JHM tissue repositories Securing funding for enterprise deployment https://cabig.nci.nih.gov/tools/catissuesuite

    15. For more information about Clinical Research @ Hopkins http://www.clinicaltrials.gov/ http://trials.johnshopkins.edu/ http://www.hopkinsmedicine.org/quality/patients/clinical_trials/