Regulatory Guidance on Source Data in EDC Trials

When we move toward the clinical studies using electronic data capture, the ‘source data’ or ‘source document’ has been an issue. Unlike the paper-CRF (case report form) based study, the source data in EDC study can be confusing and sometimes vague. If the data was directly entered into EDC system, the EDC system is the direct source and there is no another source to be verified against. This could be worrisome to some people. In a 2008 article, I talked about this issue.

Recently, both FDA and EMEA published the guidance on this issue. FDA’s guidance "Electronic Source Documentation in Clinical Investigations" was issued in December, 2010. EMEA issued its guidance last June and the guidance titled “Reflection paper on expectations for electronic source data and data transcribed to electronic data collection tools in clinical trials”.

The guidance titles seem to suggest that they are written for the data management functions, however, the discussions in these two guidelines are more relevant to the clinical sites and study monitors. Switching the clinical study from paper CRF to EDC is not just about the shift of the data entry from data management group to the clinical sites, it actually has impact on how the entire study is operated.