Overview on New Template of SDTM/ADaM Specification

Trevor

on June 6, 2022

P21

Sahil, These new columns…

Sahil,

These new columns tie in almost one-to-one with the new concepts described in the CDISC Define-XML v2.1 specification (https://www.cdisc.org/standards/data-exchange/define-xml).

There are a few instances where the columns are specific to P21E.  For instance, the "Assigned Value" column is something we use in Enterprise where we allow you to specify the assigned value of the variable and use this for validation.  This is not a feature in Community and therefore the "Assigned Value" column can be ignored.  Another example is "Common".  This is also a P21E specific field where we manage core/common variables in ADaM.  Again, can be ignored in Community.

Other fields like Standard, Has No Data, Source, Terminology..... these are all described in the CDISC Define-XML v2.1 specification.  I can provide more insight if you need -- let me know.

Thanks,

Trevor

Whereclauses tab seems to be missing in latest format of P21spec

Hi,

I am unable to find the whereclauses tab in latest format of the specification created out of P21 community version. can you please explain how should the VLM and whereclauses be completed now?

Where Clause Sheet

Hi Amit,

Where Clause sheet has been removed in Specifications excel template generated from updated p21 v4.0.1, you can find Where Clause column in Value Level Sheet and fill the value for '--ORRES' variable like '--TESTCD EQ TESTNAME' and for 'SUPPQVAL'  you can fill like 'QNAM EQ RACE1' etc....

Thanks,

Sahil Patel

Training or documentation available for P21 new specification?

Hi ,

Would like to know if there is any training or documentation available on how to use the new P21 specification template for Define 2.1 version? Looks like there has been some changes in the columns in different tabs .

Thanks,

Priyanka

Whereclause seems to be required to generate Define.xml

Hi,

I am aware that Whereclauses sheet is removed from 4.0, but when I try to generate Define.xml using the Pin21 style spec (without Whereclauses sheet), it gives me an error code 56. Then I tried to insert an empty Whereclauses sheet and it works but the information from VLM is missing from the Define.xml. Do you have any suggestions regarding this? Thank you!

Guangyong

Explain Source Column for define XML 2.1

Dear Trevor,

Thanks for helping 

Can I know about 'source' column in detail because its required for define XML v2.1 (i.e. which value we have to fill in source column located on 'variable' sheet as well 'value level' sheet).

Thanks,

Sahil Patel 

new SDTM spec template

Pls advise, how to download an empty SDTM spec template from P21.

Thanks,

Has NoData for Supplementary QNAMs

Is there a way to specify "No Data" present for a specific QNAM in supplementary domains? I was not able to find this information in Valuelevel sheet. Kindly assist.