FDA Draft Guidance: Using EHR Data In Clinical Trials | Pharma Industry Regulation | Scoop.it

The FDA [recently] released a new draft guidance document called Use of Electronic Health Record Data in Clinical Investigations. The document provides readers with recommendations on:


  • Deciding whether and how to use EHRs as a source of data in clinical investigations
  • Using EHRs that are interoperable with electronic systems supporting clinical investigations
  • Ensuring the quality and the integrity of EHR data that are collected and used as electronic source data in clinical investigations


The draft guidance focuses heavily on interoperability: “the ability of two or more systems or components to exchange information and to use the information that has been exchanged.” Integrations between EHR systems and clinical data systems, such as electronic data capture (EDC) solutions, can increase patient safety and data accuracy, streamlining the overall clinical trial data collection and analysis process. For example, EHR data, such as demographics, medical history, and adverse events, can automatically populate electronic case report forms (eCRFs) in an EDC.