t Thierry
on

 

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

Forums: Troubleshooting and Problems

l Lex
on December 15, 2015

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

 

Want a demo?

Let’s Talk.

We're eager to share and ready to listen.

Cookie Policy

Pinnacle 21 uses cookies to make our site easier for you to use. By continuing to use this website, you agree to our use of cookies. For more info visit our Privacy Policy.