1. University of Pittsburgh Department of Biomedical Informatics Healthcare institutions have established local clinical data research repositories to enable cohort discovery and provide electronic health record (EHR) data for clinical research. Clinical data research networks (CDRNs) are being established to support large scale cohort discovery, enable accrual for clinical trials, share data, and facilitate clinical research across multiple healthcare institutions by linking local data repositories. However, major challenges arise due to variability in the source EHR systems, in semantic interoperability and consistency of data elements, and in governance and regulatory policies across institutions. FUNDING ACKNOWLEDGEMENTs: This work was supported through a Patient-Centered Outcomes Research Institute (PCORI) Award (CDRN-1306- 04912) and through a CTSA NCATS Supplement Award (3UL1TR000005-09S1). PaTH Network (Phase 1)ACT Network (Phase 1) Network sites Four academic health centers in the Mid-Atlantic region 21 CTSA sites across the country Project duration 18 months (March 2014 – September 2015) 12 months (July 2014 – June 2015) Goal Identification, recruitment, and data collection from three targeted disease cohorts plus an unselected disease-agnostic longitudinal cohort Rapid identification of patients for accrual to the nation’s highest priority clinical trials across 21 CTSA institutions Infrastructure i2b2 and SHRINE i2b2 mostly plus a few non i2b2 sites, and SHRINE Data model PCORnet Common Data Model that specifies the variables and the relational tables to be implemented in the local data repository ACT Ontology and Data Dictionary that specifies the common data domains and elements and the common SHRINE ontology Data EHRs plus claims-based data and patient-reported outcomes to provide a comprehensive record of a patient’s healthcare history Minimum of three years of EHR data on the selected data elements to enable cohort identification CDRNs Background Acknowledgements ACT Data Elements The Department of Biomedical Informatics at the University of Pittsburgh is centrally involved in both CDRNs. It also leads the Data Harmonization Working Group for ACT. Since the ACT initiative began 6 months later, ACT selected data domains and data elements from the PCORnet Common Data Model. ACT implemented the ontologies and classifications in SHRINE, and to a large extent these have been adopted by PaTH. ACT and PaTH have also been informed each other in developing governance and regulatory polices. Demographics birth date, sex, Hispanic status, race, vital status, death date Diagnosis diagnosis (ICD-9, ICD-10 compatible), diagnosis date, diagnosis source (admit, discharge), diagnosis priority (primary, secondary) Procedures procedure (ICD-9, ICD-10 compatible, CPT-4 compatible), procedure date Visit Details admit date, discharge date, visit type (inpatient, ambulatory, ED) Medications medication code (RxNorm), medication classification (NDF-RT), order date, order type (inpatient, ambulatory) Laboratory Test Results lab test code (LOINC), lab test classification (LOINC parts), specimen date, result location (lab, point of care), result, units Discussion The PaTH network includes University of Pittsburgh/UPMC, Penn State, Temple University and John Hopkins University, and is funded by the Patient Centered Outcomes Research Institute (PCORI). The goal of Phase 1 is to identify and share data on three targeted disease cohorts (idiopathic pulmonary fibrosis, atrial fibrillation and obesity) and an unselected disease-agnostic longitudinal cohort across four institutions. The ACT network (Accrual of patients to Clinical Trials) includes 21 CTSA sites, and is funded by the National Clinical and Translational Science (NCATS) Award. The goal of Phase 1 is to enable rapid identification of patients for accrual to the nation’s highest priority clinical trials across 21 CTSA institutions. PaTH versus ACT Networks