Sentinel routine querying tools are SAS programs designed to run against the Sentinel Common Data Model (SCDM). They allow rapid implementation of standard queries across the Sentinel Distributed Database (SDD). The programs can be customized using various input parameters that define medical product exposures, outcomes, covariates, diagnoses, date ranges, age ranges, and other implementation details. Tools can perform simple cohort characterization and descriptive analyses, but may also be used to perform more complex adjustment for confounding and support prospective surveillance activities.
The Cohort Identification and Descriptive Analysis (CIDA) program is the foundation of the routine querying system. CIDA is responsible for identifying, extracting, and characterizing cohorts of interest from the SDD based on the specification of a number of requester-defined options (e.g., continuous enrollment requirements, incidence criteria, inclusion/exclusion criteria).
This report contains the rates of the 10 leading causes of death in the United States and the proportional mortality of these causes.
This project was a one-time assessment of the association between influenza vaccination and birth outcomes (cleft lip without cleft palate, cleft palate without cleft lip, or cleft lip with cleft palate).
The authors conducted a plasmode simulation to compare relative performance of 5 methods involving propensity score (PS) matching for subgroup analysis, including methods frequently used in applied literature whose performance has not been previously directly compared.
This report contains estimated numbers of idelalisib users and idelalisib users with concomitant use of several anti-cancer agents as well as cancer diagnoses around the time of idelalisib use.
The FDA, Sentinel Operations Center, and Collaborating Institutions have developed Principles and Policies to govern participation in the activities of the Sentinel Initiative. The Sentinel System Principles and Policies are currently under review by Collaborating Institutions and are now available on the Sentinel Initiative website.
This query investigated use of tumor necrosis factor (TNF) alpha inhibitor drugs, granulocyte colony-stimulating factor (GC-SF) drugs, and intravenous iron.
The purpose of this paper is to help regulatory scientists develop and refine recommendations about which drug safety questions are most amenable to sequential surveillance.
These reports contain the estimated rates of inpatient rhabdomyolysis and/or creatine kinase (CK) laboratory results following new use of statins or angiotensin-converting enzyme (ACE) inhibitors.
The Sentinel Data Quality Review and Characterization Programs are used by the Sentinel Operations Center (SOC) for data quality review and characterization of the Sentinel Distributed Database (SDD). To create the SDD, each Data Partner transformed local source data into the Sentinel Common Data Model (SCDM) format. The SOC created a set of data quality review and characterization programs to ensure that the SDD meets reasonable standards for data transformation consistency and quality and that the SDD data meets expectations needed for a distributed health data network.
The Sentinel Operations Center (SOC) coordinates the network of Sentinel Data Partners and leads development of the Sentinel Common Data Model (SCDM), a standard data structure that allows Data Partners to quickly execute distributed programs against local data.