Vienna, Austria,
2021-06-30 12:41
(971 d 06:08 ago)

Posting: # 22442
Views: 1,578

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

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.

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Helmut Schütz

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2021-06-30 18:26
(971 d 00:23 ago)

@ Helmut
Posting: # 22444
Views: 1,151


Hi Helmut,

thank for sharing this one.
I like Annex 2 where Validation process is written in a detailed manner

Kind regards,
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