EMA Reflection Paper on the Use of Electronic Data in Clinical Trials published

The final Reflection Paper on expectations for electronic source data and data transcribed to electronic data collection tools in clinical trials has been published. It outlines the current opinion of the EU GCP Inspectors Working Group on the use of electronic data capture in clinical trials and on related inspections.

The GCP Inspectors Working Group has noted the CDISC (Clinical Data Interchange Standards Consortium) e-SDI Group publication on standards and electronic source data within clinical trials from November 2006. In particular the CDISC publication includes a set of user requirements for source data, irrespective of the media or technology used to hold the data. These requirements describe a group of high-level principles, which, when they are adhered to, provide a good basis for the acceptability of source data. These principles should be internationally applicable - an important consideration given the global nature of clinical trials.

The EU GCP Inspectors Working Group has, therefore, chosen to centre this reflection paper on these user requirements, knowing also that they have been prepared on the basis of the ICH GCP1 and other requirements. In this context the reflection paper has categorised the requirements into five topics and discusses issues relating to each:

  • Creation and modification of systems
  • Creation, modification and transfer of data
  • Control
  • Copying
  • Storage

(this does not imply endorsement of other concepts or details in the CDISC publication, which contains an extensive discussion of the issues involved, although they could also apply).

The Reflection Paper outlines the current expectations of GCP inspectors. Any departure from this paper would need to be justified. The GCP Inspectors Working Group considers that a reflection paper on the issues is appropriate at this stage.

Compiled by
Wolfgang Schmitt
On behalf of the European Compliance Academy (ECA)

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