EMA - Guideline on computerised systems and electronic data in clinical trials

22nd March 2023

EMA

Guideline on computerised systems and electronic data in clinical trials, 9th March 2023.

This guideline replaces the 'Reflection paper on expectations for electronic source data and data
transcribed to electronic data collection tools in clinical trials' (EMA/INS/GCP/454280/2010).

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