DD0150 - Missing expected Standard, advise how to make the generator include the SDTMIG 3.3 def:Standard entry automatically?

Pinnacle 21 Support
1

Hi Certara/P21 Support,

We are using Pinnacle 21 Community to generate a Define-XML 2.1 file for an SDTM study configured as SDTM-IG 3.3.

The generated Define-XML is identified as SDTM-IG 3.3 in the ODM/FileOID and MetaDataVersion OID, for example:

FileOID="...SDTM-IG.3.3"

and:

def:DefineVersion="2.1.0"

However, in the generated <def:Standards> section, P21 only creates the controlled terminology standard:

<def:Standard OID="STD.SDTM 2023-03-31" Name="CDISC/NCI" Type="CT" Version="2023-03-31" PublishingSet="SDTM" Status="FINAL"/>

It does not generate the expected implementation guide standard:

<def:Standard OID="STD.SDTMIG.3.3" Name="SDTMIG" Type="IG" Version="3.3" Status="FINAL"/>

As a result, when validating the Define-XML in P21 Validator, we get:

DD0150 - Missing expected Standard

We tried adding a new Standards tab to the P21 Excel specification, but the generator appears to ignore that tab and still outputs only the CT standard.

Could you please confirm whether this is a known issue or limitation in the P21 Define.xml Generator/specification template, and advise how to make the generator include the SDTMIG 3.3 def:Standard entry automatically?

Thanks,
José

2

Hi José,

To get the SDTMIG 3.3 entry in your def:Standards section, you need to populate the “Standard” column (column G) on the Datasets tab of the Excel spec with SDTMIG 3.3 for each dataset.

One important note: make sure there is no hyphen (-), use SDTMIG 3.3, instead of SDTM-IG 3.3.
Once that’s in place, the generator will include the expected <def:Standard Type=“IG”> entry and DD0150 should no longer fire. Let us know if that helps!

Kind regards,
Lili

1 Like
3

Thanks a lot. it works.

cheeers.

Jose.