EMA eSource Direct Data Capture (DDC) qualification opinion issued

the regulatory acceptability to use an eSource Direct Data Capture in Clinical Trials

This Qualification Opinion is intended to give information about the regulatory acceptability to use an eSource Direct Data Capture (DDC, or simply eSource in this document) in clinical trials conducted to support a Marketing Authorization Application for a medicine.

In the context of this Qualification Opinion, the general term “eSource DDC” refers to an electronic application and/or device that allows direct entry of source data, and to directly identify some of these data as CRF (Case Report Form) data, for clinical trial purposes at the point of care by investigator site staff, for example via an electronic tablet. It is not intended to identify or support a specific, proprietary system, but to discuss some of the characteristics a system for direct data entry should present. It should also be noted that guidance on Electronic Systems is currently under development at EMA, and once into force it would constitute the definitive guidance.

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