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Topic: Recent Audit Finding in an EMA-Audit which appears to be in contradiction to current CDISC rules 

Presenter: Andrea Rauch (gPO Clinical Data Standards, Boehringer Ingelheim Pharma GmbH & Co. KG)

Slide: 

IE_finding.pptx

Recording of the Session in German Language (Filesize ~155 MB):

https://my.hidrive.com/lnk/1puyxVS3

(Note: this is a link to an external german Filehoster due to the Wiki filesize restrictions of max 20 MB) 


As an outcome of the discussion the following questions were raised by the community:

  1. Are there any official 'communcation channels' between the CDISC/E3C organisation and the EMA (European Medical Agency)? This was asked in the context of whether such a topic (inconsistencies between EMA requirements and CDISC rules) could be addressed/discussed.
  2. Question to CDISC/E3C:
    Why there is no official feedback from CDISC to this topic? Our understanding is that CDISC should be a global standard and not only focus on FDA requirements. So why such requirements of an important regular authoritie as the EMA is not of interest for CDISC? Even if the EMA does not require the submission of RAW data, the EMA seems to have a clear understanding about rules for data capture and this should be covered by the CDASH Standards. However, the current version does not support this EMA request as described in the slides by Andrea Rauch.   





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