Sentinel Data Quality Assurance Practices

Project Title Sentinel Data Quality Assurance Practices
Date Posted
Thursday, March 23, 2017

The Food and Drug Administration (FDA) set forth its current recommendations for data quality assurance (QA) in the following document: “Guidance for Industry and FDA Staff: Best Practices for Conducting and Reporting Pharmacoepidemiologic Safety Studies Using Electronic Healthcare Data” (Guidance), section IV.E “Best Practices – Data Sources: Quality Assurance (QA) and Quality Control (QC),” in May 2013. This Guidance describes best practices that particularly apply to observational studies designed to assess the risk associated with a drug exposure using electronic healthcare data.

The Sentinel Operations Center has drafted a document describing the ways in which Sentinel data quality assurance procedures align with FDA’s guidance.

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