AD0018 check in ADAE

July 25, 2017

Dear sir/madam,

I noticed in the ADaM 1.0.xml configuration file that validation rule AD0018 is not active for the ADAE domain .

Could you fix this by adding the rule in the upcoming version of the config files, cfr below?

<ItemGroupDef OID="IG.ADAE" Name="ADAE" Repeating="Yes" IsReferenceData="No" Purpose="Analysis" def:Structure="One record per subject per each AE recorded in SDTM AE domain" def:Class="ADAM OTHER" def:ArchiveLocationID="Location.ADAE">
        <TranslatedText xml:lang="en">Adverse Event Analysis Dataset</TranslatedText>
    <def:leaf ID="Location.ADAE" xlink:href="adae.xpt">
    <val:ValidationRuleRef RuleID="AD0018" Active="Yes"/>   
    <val:ValidationRuleRef RuleID="AD0037" Active="Yes"/>    

Jeroen Den Herder (SGS Life Sciences)


Hi Jeroen,

Thank you for reporting this issue! It brings our attention to other ADaM validation checks which are applicable to all analysis datasets, but for some reasons were not applied to ADAE.

Kind Regards,