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Safety Analytics

Webinar: Safety Analytics Webinar: Spotlight – Hepatotoxicity and Adverse Event Groupings

28 October at 9:00-10.30 (EDT) / 13:00-14:30 (GMT) / 14:00-15:30 (CET)

Info

Information and Registration

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Data Transparency

The /wiki/spaces/WEL/pages/220168194 within the Data Transparency Working Group has published a new response to a question regarding MHRA Clinical Trials Regulation Guidance. View the team's response to the following question here.  

'Please confirm instances that would define the OCCDS analysis dataset to be the Adverse Event sub-classification.'

Do you have a SDTM ADaM Implementation question? You can send your questions to the team by emailing workinggroups@phuse.global. 

Optimizing the Use of Data Standards

The SDTM ADaM Implementation FAQ project within the Optimizing the Use of Data Standards Working Group has published a new response to a question regarding SDTM/ADaM IG Nuances. View the team's response to the following question here

'Please confirm instances that would define the OCCDS analysis dataset to be the Adverse Event sub-classification.'

Do you have a SDTM ADaM Implementation question? You can send your questions to the team by emailing workinggroups@phuse.global. 

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