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.
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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Dif-tor heh smusma 🖖🏼 Довге життя Україна!
![[image]](https://static.bebac.at/pics/Blue_and_yellow_ribbon_UA.png)
Helmut Schütz
![[image]](https://static.bebac.at/img/CC by.png)
The quality of responses received is directly proportional to the quality of the question asked. 🚮
Science Quotes
Complete thread:
- EMA: Guideline on computerised systems and electronic data in clinical trialsHelmut 2021-06-30 10:41 [BE/BA News]
- Validation! mittyri 2021-06-30 16:26