Note that the SDTM-MSG indicates that the datasets should be displayed in the following Class order: * TRIAL DESIGN * SPECIAL PURPOSE - Subject-Level * INTERVENTIONS * EVENTS * FINDINGS * FINDINGS ABOUT – not yet added to the NCI/CDISC Controlled Terminology as of the time of writing this document * RELATIONSHIP
The latest CT still does not have "FINDINGS ABOUT" as an observation class, so stating def:Class="FINDINGS ABOUT" raises a validation message. What policy should be followed in this case:
1) Accept the message, and explain it by referring to the define-XML specification
2) Report FA with def:Class="FINDINGS", but in this case the rule for alphabetical order of findings domains does not place it at the end.
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Hi,
The define-XML specification version 2.0 states:
Note that the SDTM-MSG indicates that the datasets should be displayed in the following Class order:
* TRIAL DESIGN
* SPECIAL PURPOSE - Subject-Level
* INTERVENTIONS
* EVENTS
* FINDINGS
* FINDINGS ABOUT – not yet added to the NCI/CDISC Controlled Terminology as of the time of writing this document
* RELATIONSHIP
The latest CT still does not have "FINDINGS ABOUT" as an observation class, so stating def:Class="FINDINGS ABOUT" raises a validation message. What policy should be followed in this case:
1) Accept the message, and explain it by referring to the define-XML specification
2) Report FA with def:Class="FINDINGS", but in this case the rule for alphabetical order of findings domains does not place it at the end.
Thanks,
-- Thierry