Source Documents And Data Retention In Drug Safety

By Bart Cobert

In late November 2012, FDA released a new draft guidance entitled “Electronic Source Data in Clinical Investigations”.

Although this document does not address drug safety or pharmacovigilance directly, and although it does talk about source data in trials, it really is a review of some Good Documentation Practices.  We will look at in the context of drug safety.

The draft guidance discuses four aspects of source data: Data Capture, Data Review, Record Retention by Investigators and Data Access.  There are not too many surprises here for those who are aware of Good Document Practices.