The SOC has drafted a document describing the ways in which SOC data quality assurance procedures align with FDA’s standards.
Summary table assessment of the use of all new molecular entities (NMEs) approved in 2013 and 2014 in the Sentinel Distributed Database.
This day-long seminar will provide an overview of Sentinel capabilities, including:
An individually randomized trial of a practice and patient level educational intervention to increase anticoagulant use for individuals with atrial fibrillation and increased risk of stroke (i.e. CHA2DS2-VASc score ≥2). This project is a proof of concept effort, the first trial conducted using Sentinel Infrastructure, and will inform future interventional studies that are designed to utilize existing healthcare data as part of their design.
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.
This activity will investigate the feasibility of conducting outcome-based TreeScan analyses within the Mini-Sentinel Distributed Database (MSDD) using angioedema and Achilles tendon rupture (ATR) as test examples. This activity will assess whether TreeScan is able detect known associations at the specific drug and class level.
This protocol describes the PRISM program’s efforts to develop a large database to be used for retrospective studies of potential adverse events following vaccination in pregnant women by linking mothers with infants and by incorporating an additional data source, specifically birth certificate data.
Sentinel modular programs (MPs) allow rapid implementation of standard queries across the Sentinel Distributed Database (SDD). MPs are designed to run against the Sentinel Common Data Model (SCDM). They are written in SAS and can be customized using various parameter settings that define exposures, outcomes, covariates, inclusion/exclusion criteria, date ranges, age ranges, and other implementation details.
The Office of Generic Drugs (OGD) at the Center for Drug Evaluation and Research (CDER) is interested in exploring the potential for the Sentinel System to support investigations of manufacturer-level product switching. The aims of this project are:
Modular program-based one-time assessment of incident use of two influenza antiviral drugs during the five previous influenza seasons. The query was run against the Sentinel Distributed Database (SDD) for the time period of January 1, 2010 through December 31, 2015.