In June 2021, the European Medicines Agency (EMA) released a new draft guidance document for public consultation entitled Guideline on computerised systems and electronic data in clinical trials. This draft guidance is slated as being the replacement for the Reflection paper on expectations for electronic source data and data transcribed to electronic data collection tools in clinical trials that was published in 2010.
By
Paul Fenton |
Oct 28, 2021 4:54:43 PM |
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Regulations & Standards
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