Findings About Observation Class

Pinnacle 21 Support Troubleshooting and Problems
1

See: http://www.opencdisc.org/forum/dd0055-invalid-class-value-community-21

2

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