FDA Finalizes Widely Anticipated Guidance on Use of Electronic Source Data in Clinical Investigations

Regulatory Affairs Professionals Society: September 19, 2013

US Food and Drug Administration (FDA) officials have finalized a November 2012 draft guidance on the use of electronic source data in clinical investigations, calling for its greater use to promote the reliability, quality, integrity and traceability of clinical data.

Background

The guidance, Electronic Source Data in Clinical Investigations, was first released in January 2012, but after FDA received a deluge of comments—42 in all—it revised and re-released the draft guidance on 19 November 2012. At the time, FDA said it was intended to be used by members of industry, as well as clinical research organizations (CROs), data management centers and clinical investigators.

The premise of the guidance is relatively simple: It’s better for all parties involved to capture clinical data in electronic form. Why? FDA believes it eliminates unnecessary duplication of data, reduces transcription errors, encourages timely reporting of data (i.e. at the time of the patient’s visit), eliminates transcribing errors between non-electronic and electronic systems, promotes real-time review of trials and ensures data collected is both accurate and complete. Read more