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EMA Explains How To Use Electronic Devices For Direct Trial Data Capture

 
• By Vibha Sharma

In response to a proposal by Novartis, the European Medicines Agency has outlined the broad characteristics of electronic systems used for directly capturing clinical trial data by investigator staff.

Clinical trial
EMA Outlines Ideal Characteristics Of Systems For Direct Data Entry • Source: Shutterstock

The European Medicines Agency has issued guidance on the regulatory acceptability of using apps or electronic devices to directly capture clinical trial source data at the point of care by investigator site staff.

The guideline explains how some of the data captured through apps or electronic devices such as tablets can be identified as “case report form” (CRF) data for clinical trial purposes....

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