PROs and Data Collection: Regulatory Requirements

3. Electronic CRFs

3.1. Regulatory Requirements

The EMA issued a reflection paper in 2010 summarising what GCP inspectors will accept as electronic data capture. Read the complete document.

This document states, among many recommendations, that:

There must be criteria under which NCAs will consider electronic records and signatures to be trustworthy, reliable and generally equivalent to paper records and handwritten signatures executed on paper.
There must be a system validation to ensure accuracy, reliability, consistent intended performance (i.e. validation of the eCRF software), and the ability to discern invalid or altered records.

Likewise the FDA has issued very detailed and demanding rules under which conditions they accept electronic data capture. In a guidance for industry the FDA has explained how to use eCRFs in clinical trials. The Guidance for Industry recommends that:

The protocol should identify when a computerised system will be used to create, modify, maintain, archive, retrieve, or transmit data.
Documentation of software and hardware used should be kept with study records (in the Trial Master File (TMF)).
An electronic record is the source document if the original observation is entered directly into a computerised system.