OD0080 for AE Coding Variables

Hi Ana,

This is a current limitation of define.xml standard. OD0080 check will have an exception for MedDRA coding in the next release.

Thanks,

Sergiy

Hi

Using the Define v2.0 validation for the define.xml and we are getting the errors



//ItemDef[@OID=‘IT.AE.AELLTCD’]



@DataType



integer, text



OD0080



ItemDef/CodeList ‘DataType’ mismatch



//ItemDef[@OID=‘IT.AE.AEPTCD’]



@DataType



integer, text



OD0080



ItemDef/CodeList ‘DataType’ mismatch



//ItemDef[@OID=‘IT.AE.AEHLTCD’]



@DataType



integer, text



OD0080



ItemDef/CodeList ‘DataType’ mismatch



//ItemDef[@OID=‘IT.AE.AEHLGTCD’]



@DataType



integer, text



OD0080



ItemDef/CodeList ‘DataType’ mismatch



//ItemDef[@OID=‘IT.AE.AEBDSYCD’]



@DataType



integer, text



OD0080



ItemDef/CodeList ‘DataType’ mismatch



//ItemDef[@OID=‘IT.AE.AESOCCD’]



@DataType



integer, text



OD0080



ItemDef/CodeList ‘DataType’ mismatch

The variables for AE all defined as number in the SDTM IG and also they have attached the codelist of MedDRA. We attach the MedDRA dictionary name as an external code list in our define.xml. How do we solve getting rid of this error.

Thanks

Ana