What is the right thing to do once data has been transcribed into eCRFs – do we keep a paper copy of the data, or can it be destroyed?

Once original source records are transcribed into electronic format, they are required to be archived as per the Predicate rules 21 CFR 312.62(b) and 812.140(a)(3). In their FDA’s 2013 document Guidance for Industry – Electronic Source Data in Clinical Investigations, Section III(c) states: “…When data elements are transcribed from paper sources into an eCRF, the clinical investigator(s) must also retain the paper sources, or certified copies, for FDA review.”