Helmut
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Vienna, Austria,
2021-06-30 10:41
(26 d 14:14 ago)

Posting: # 22442
Views: 255
 

 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.

Dif-tor heh smusma 🖖
Helmut Schütz
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mittyri
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Russia,
2021-06-30 16:26
(26 d 08:28 ago)

@ Helmut
Posting: # 22444
Views: 199
 

 Validation!

Hi Helmut,

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

Kind regards,
Mittyri
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