EMA: Guideline on computerised systems and electronic data in clinical trials [BE/BA News]

posted by Helmut Homepage – Vienna, Austria, 2021-06-30 10:41 (110 d 11:27 ago) – Posting: # 22442
Views: 632

Dear all,

the EMA’s Good Clinical Practice Inspectors Working Group published a draft guideline (end of consultation 17 December 2021), which will replace the ‘Reflection paper on expectations for electronic source data and data transcribed to electronic data collection tools in clinical trials’ of 2010.

Dif-tor heh smusma 🖖
Helmut Schütz
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