Sentinel Data Quality Assurance Practices

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.