Rule DD0112 'Missing MedDRA definition' with no reason or resolution

l Lanjun

on June 26, 2023

Dear all,

When generating define.xml and using P21 Community validator, we found a quite interesting issue, DD0112 'Missing MedDRA definition':

There was information of MedDRA with a name and version in both variable's CT and External Dictionaries parts, however this issue still came out without more information about why and how this issue occurred or resolved.

Snapshot for MedDRA Information in variable CT information

Snapshot for MedDRA Information in External Codelist

Then we found the resolution was to change the CT Name from 'MedDRA DICTIONARY' to 'MedDRA'... very interesting, right?

So we would like to share this experience for any one else meeting this.

Forums: Define.xml

Lex

on June 26, 2023

In the Define-XML v2.1…

In the Define-XML v2.1 specification it is now explicitly stated for the ExternalCodeList Dictionary attribute:

CDISC Submission Value (=CodedValue) as listed in the NCI/CDISC Controlled Terminology, CodeList Dictionary Name, NCI Code C66788. This CodeList is extensible. Samples: COSTART, ICD, LOINC, MedDRA, SNOMED, WHOART, WHODD.

j Jozef

on June 26, 2023