Possible false-positive DD0113 for AEBDSYCD MedDRA reference in Define-XML

Pinnacle 21 Support
1

Hello,

We are receiving the following Pinnacle 21 finding:



DD0113 - Missing MedDRA reference on AEBDSYCD variable

However, after reviewing the generated define.xml, the MedDRA references appear to be correctly defined.

For the variable AEBDSYCD, the ItemDef correctly points to the integer MedDRA dictionary:



<ItemDef OID="IT.AE.AEBDSYCD" Name="AEBDSYCD" DataType="integer" Length="8">
    ...
    <CodeListRef CodeListOID="CL.AEDICT_I"/>
</ItemDef>

The paired text variable AEBODSYS points to the text MedDRA dictionary as expected:



<ItemDef OID="IT.AE.AEBODSYS" Name="AEBODSYS" DataType="text">
    ...
    <CodeListRef CodeListOID="CL.AEDICT_T"/>
</ItemDef>

Both referenced codelists are also defined as external MedDRA dictionaries:



<CodeList OID="CL.AEDICT_I" Name="Adverse Event Dictionary Code" DataType="integer">
    <ExternalCodeList Dictionary="MEDDRA" Version="25.0"/>
</CodeList>

<CodeList OID="CL.AEDICT_T" Name="Adverse Event Dictionary Text" DataType="text">
    <ExternalCodeList Dictionary="MEDDRA" Version="25.0"/>
</CodeList>

Based on this, the Define-XML structure appears correct:



AEBODSYS  -> CL.AEDICT_T -> MEDDRA 25.0
AEBDSYCD  -> CL.AEDICT_I -> MEDDRA 25.0

We also confirmed that AEBDSYCD is defined as an integer variable and is linked to CL.AEDICT_I, while CL.AEDICT_I is defined with ExternalCodeList Dictionary="MEDDRA" Version="25.0".

Could you please help confirm why Pinnacle 21 is still reporting DD0113 for AEBDSYCD? This may be a false-positive or an issue with how the tool is interpreting the external dictionary reference.

Thank you.

2

Hi Jose,

It looks like a bug. P21 validator DD0113 check picks the first definition of MedDRA dictionary and ignores additional ones.

You can 2 basic options until this bug fix.

  1. Explain DD0113 reported validation issues in Reviewers Guide as false-positive findings due to P21 known bug.
  2. Do not provide MedDRA reference to *CD (AELLTCD, …) variables. This is current common practice in the industry.

Sorry for inconvenience.

Kind Regards,
Sergiy

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