FDA posts final guidance on electronic source data

When the FDA published draft guidance on electronic source data in clinical trials back in January 2012, it sparked a widespread debate, some of which was critical of the proposals. Now, after a reworked draft was received more favorably by the industry, the administration has published its final guidance on the topic.

The final version is broadly in line with the second draft the FDA released in November, but has been tweaked in a few areas to cut the risk of the document being misinterpreted. RAPS notes the electronic data capture section has undergone the most extensive rewrite, with the FDA making changes to address concerns raised by PhRMA. The guidance now states that paper-based documents should be kept only if they were part of the original data-reporting process.

Clarification of such points cuts the risk of a company inadvertently failing to comply with guidance, or maintaining inefficient practices in the belief they are required by FDA. While the clinical trial industry was relatively slow to use electronic formats for data capture and other aspects of studies, the processes and technologies are now well established. FDA therefore focused its guidance on compliance, best practices and--where possible--harmonization, giving the industry a framework for reaping the benefits of electronic source data.

Having everyone capture results electronically cuts duplication of data, transcription mistakes and other shortcomings of paper-based and hybrid systems. Recognition of these benefits has driven demand for eClinical technologies in recent years, creating business for Medidata ($MDSO), Oracle ($ORCL) and a host of smaller companies.

- read the guidance (PDF)
- check out RAPS' take