This study is being conducted due the Food and Drug Administration’s (FDA) interest in using Real World Evidence from electronic health records (EHRs). The purpose of this study is to establish a routine Sentinel querying capability within a network of electronic health record databases. The network specifically being queried for this study is the Patient-Centered Outcomes Research Center (PCORnet) Network. SAS® query packages that have been developed by the PCORnet Coordinating Center in collaboration with the FDA and Sentinel Operations Center (SOC) will be run by select PCORnet Network Partner organizations.
This practice will be used to detect and define cohorts of patients as requested by the FDA. The query packages sent out will include preexisting PCORnet reusable tools which includes PCORnet Modular Programs (PMPs) and Menu Driven Queries (MDQs). Queries sent out will likely assess essential baseline, covariate, and vital characteristics data within each organization’s application of the PCORnet Common Data Model(CDM). Pediatrics (including neonatal intensive care unit), pregnancy/birth outcomes, cancer, death and cause of death data, and demonstrated ability to link EHR data to claims are the deliberate areas of interest held by the FDA.These queries are considered to be public health surveillance activities, steered under the FDA’s public health authority. For this reason, the queries are not subject to the Common Rule. The final aggregated will be available to the public. No individual-level data will be sent to the investigator for this project.
Please follow this link for more information on the Sentinel Initiative: https://www.sentinelinitiative.org/