OpenCDISC Validator 1.4.1 - User Define Formats

Hi Ashok, First of all, we

Hi Ashok, 

First of all, we always recommend a usage the most recent version of OpenCDISC validator.

There are two types of checks for Extensible CT.

1. SD0037 is a metadata check to ensure that your define.xml file describes data correctly.

2. CTxxxx are CT checks to report all custom terms added to standard CT codelist.

Those two sets of checks are independent.

An approach used in v1.3 is outdated. Please be sure to utilize the most recent versions of validator to avoid problems with clients and Regulatory Agencies.

Kind Regards, 

Sergiy

CTxxxx Codelist extensible

Thanks Sergiy for your response.

Example : As per CT Codelist the values in "UNIT" are extensible and moreover in the Lab data we will have different units which are outside the CT codelist, in this situation we add the user define codelist in define.xml inorder to avoid the warning in validator report.

My understanding is this is one of the reason we add the user define codelist in define.xml, but in the latest verions the purpose is not served as still we have the warnings after running the SAS xpt's with define.xml.

My request is to handle this as the with the current situation we should add many explantions in the data guide, ideally there should be minimum explantions in the data guide.

Thanks & Regards

Ashok

Hi! CTxxxx checks are needed

Hi!

CTxxxx checks are needed because many users still have incorrect understanding what is an "Extensible" codelist.

New terms can be added as long as they are not duplicates, synonyms or subsets of existing standard terms. E.g., "10^3/mL" is a synonym of "10^6/L", "LEFT ARM" is a subset of "ARM".

Based on our experience LB units are about 98% CDISC CT compliant when correct mapping is done. All real new terms should be submitted to CDISC CT team to be included into the next release of Terminology standard.

Kind Regards,

Sergiy