FDA to clarify electronic data guidance?

Big pharma has called for the FDA to clarify the scope and purpose of its draft electronic source documentation guidance.

The US Food and Drug Administration (FDA) published draft guidance in January to improve handling of electronic data in clinical trials . However, many respondents have questioned the scope and purpose of the document.

“The title of the document is misleading since the title is about ‘Electronic Source Documentation’ whereas the document content is very much focused on the eCRF (electronic case report forms)”, said Boehringer Ingelheim.

A number of other biopharm companies made similar points. GlaxoSmithKline (GSK) summarised these concerns by asking the FDA to make a clear distinction between practices for eSource data and those for eCRF in general.

Tech, standardisation

Sanofi-aventis said lack of standardisation means it is currently difficult to transfer data directly into the eCRF from various electronic sources. Different devices from different manufacturers may lack a common standard.

Following this model would necessitate the programming of interfaces to electronic medical records and devices at each site. This exceeds the capabilities of even big pharma, said Sanofi, and most investigators lack the skills to oversee this work, as recommended in other guidance.

Investigator burden

Sanofi is also concerned about how the data transfer model shifts responsibilities onto investigators. Transferring data directly into the eCRF makes the investigator responsible for “adequacy and accuracy, which is beyond the investigator’s control”.

Boehringer said the draft recommends multiple signoffs by the investigator, adding to workload and delaying data review. Also, recommending investigators generate write-protected copies of data places an additional burden on them, said GSK.

“We encourage the agency to carefully consider whether this guidance is intended to significantly disrupt current industry practices by shifting all operational responsibilities of electronic data capture, review and archival onto clinical investigators”, said Eli Lilly.


The need for harmonisation of terminology and with other regulatory agencies was a common comment. In particular, harmonisation with the Reflection Paper on Expectations for Electronic Source Data from the European Medicines Agency (EMA) was called for by companies.

“Since most clinical trials in Phase III are multinational, it would be preferable, if FDA could harmonise this guidance with the EMA and agree on common principles for eCRF. At a minimum, please ensure that there are no conflicting requirements in these two guidances”, said Sanofi.

Bayer, Sanofi, Lilly, GSK, AstraZeneca, Novartis, MedImmune and Boehringer are among the sponsors that have responded to the draft . A number of other trade groups and contract research organisations (CRO) have also given feedback.