On November 20, FDA announced the availability of draft guidance for industry entitled “Electronic Source Data in Clinical Investigations.” The document, which revises and updates previous FDA draft guidance, provides guidance to sponsors, contract research organizations (CROs), data management centers, clinical investigators, and other stakeholders involved in capturing, reviewing, and archiving electronic source data in FDA-regulated clinical investigations.

FDA defines “source data” as information found in original records of clinical findings, observations, or other activities in a clinical investigation that are used for the reconstruction and evaluation of the trial. Due to the widespread use of computerized systems to capture clinical study data, it is now common to find source data recorded electronically, such as clinical data that is recorded in electronic health records, electronic lab reports, and electronic device images.

The latest draft guidance is intended to promote the collection of electronic source data and assist in ensuring its reliability, quality, integrity, and traceability. According to FDA, an increase in the capture of such source data electronically will help to:

  • Eliminate unnecessary duplication of data;
  • Reduce the risk of transcription errors;
  • Encourage source data entry at the time of a patient’s visit;
  • Promote real-time data access for review; and
  • Ensure the accuracy and completeness of the data.

Interested stakeholders can submit comments (electronic or written) to FDA regarding the draft guidance until January 22, 2013.