Invalid Standard Name value 'SDTM-IG'

Trevor

on June 23, 2022

P21

Amit,This rule (DD0021…

Amit,

This rule (DD0021-Invalid Standard Name value) algorithm is correct, but updating the Description was missed during our first pass at Define-XML 2.1 implementation. Thank you for pointing it out to us. I've created a ticket to have the rule description updated.

As for the algorithm, we have logic such that:

• For Define-XML 2.1, we look up values against the STDNAM (C170452) codelist defined in Define-CT
  • ADaMIG, SDTMIG, SDTMIG-AP, SDTMIG-MD, SENDIG, SENDIG-AR, SENDIG-DART
     
• For Define-XML 2.0, we look for values defined in the Define-XML 2.0 PDF document
  • SDTM-IG, ADaM-IG, SEND-IG
     
• For Define-XML 1.0, we look for values defined in the Define-XML 1.0 PDF document
  • CDISC SDTM, CDISC SEND, CDISC ADaM
     

To correct your issue and have DD0021 no longer appear in your validation results, update your Standard to be formatted properly (e.g. no hyphen).  This is discussed more here: https://www.pinnacle21.com/projects/validator/definexml-21-support

I hope this helps,

Trevor
Product Manager

P21 ID DD0127 'Invalid use of Alias'

Thank you so much for your quick turn around. The above error got resolved after updating your suggestion. However, I have got another issue with variable Label ECOCCUR which is populating while validating define.xml(This error is not populating while validating  .xpt). As per CDISC V3.3 it's is 'Occurrence' and P21 says 'Occurrence Indicator' which doesn't match SDTM IG Version3.3 . Can this be also be looked at your end to avoid the error to be populating for define.xml.

I have one more question regarding P21 ID DD0127 'Invalid use of Alias'. The rule says "An Alias must not be provided when the codelist is non-standard (i.e., code list is sponsor defined)." However I am getting error for most of the code list  e.g ACN,AESV,AGEU,FRQ,IECAT etc. 

Can you please help me to understand what exactly needs to be fixed to remove this error.

I look forward to hear your valuable response.

Thanks in advance!!

Sergiy

on June 27, 2022

P21

This bug will be fixed in the next release

Hi Amit, 

Thank you for reporting this bug! Its fix will be available in the next version of validation engine.

Kind Regards,
Sergiy

Thank you for looking into…

Thank you for looking into the bug. However , I have one more question regarding P21 ID DD0127 'Invalid use of Alias'. The rule says "An Alias must not be provided when the code list is non-standard (i.e., code list is sponsor defined)." However I am getting error for most of the code list  e.g ACN,AESV,AGEU,FRQ,IECAT etc. Attached is the screenshot for the same where correct code list ID has been used for standard code list value.

Can you please help me to understand what exactly needs to be fixed to remove this error. Or please confirm if this is bug from P21 as well.

I look forward to hear your valuable response.

Thanks in advance!!

Trevor

on June 29, 2022

P21

Amit, DD0127 is firing…

Amit,

DD0127 is firing because you specified C-codes for certain codelists, but did not specify the name of the terminology correctly (or at all).  What values are you populating on the Codelists tab under the Terminology column?  Any records with a codelist c-code needs to have a value under Terminology.

Thanks,

Trevor

Hi Trevor,Attached is the…

Hi Trevor,

Attached is the screenshot where i have mentioned correct CT code. What value should i give under Colum E(Terminology) which is introduced in the latest version. 

I tried removing attribute def:IsNonStandard="Yes"  from xml code manually however it's is giving some other errors in P21 validations.

look forward to hearing from you!!

Thanks,

Amit