Guided Notes

Clinical Research Informatics

Clinical trial systems (CTMS, EDC), cohort discovery (i2b2), common data models (OMOP, PCORnet), real-world data and evidence, data standards (CDISC) and research privacy.

Systems in clinical research

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SystemPurpose
CTMS (clinical trial management system)Studies, sites, enrollment, budgets, visits
EDC (electronic data capture)Case report forms for trial data (e.g. REDCap, Medidata Rave)
eConsentElectronic informed consent
Cohort discovery tools (e.g. i2b2, TriNetX)Count eligible patients from EHR data before a study
Biobank/LIMSSpecimens linked to data
Research data warehousesDe-identified or limited data for analysis
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