What the European Medicines Agency’s qualification opinion means for electronic clinical data capture

The European Medicines Agency (EMA) issued a qualification opinion following a request concerning proprietary eSource DDC (Direct Data Capture) technology. This technology allows the capture of clinical study source data electronically by investigator site staff at the point of care. In its opinion, EMA’s Committee for Medicinal Products for Human Use (CHMP) does not identify or support any specific, proprietary system. The Committee rather discusses and gives responses in relation to some of the characteristics a system for direct data entry should present. The general principles outlined in the opinion could be applied to different scenarios and to other eSource DDC technologies. Specific characteristics of different systems may require specific evaluation.

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