Define.XML Generation and Mandatory paramter values

Define 1.0 Document Manadatory Description

Dear Open CDISC: Per SDTM 3.1.3 IG there are some DM variables that are define as expected. Per Define 1.0 it seems that Mandatory = "Yes" should be used for Req and Exp variables. Can you confirm please? Generated excerpt: From Section 2.1.2.3 Valid values are "Yes" and "No". "Yes", indicates that the clinical data for an instance of the containing item group is required or would be incomplete without an instance of this item. Thanks for your help Joyce

Mandatory

According to the ODM and Define-XML specification the Mandatory attribute should be "Yes" for Required variables. From the Define-XML v2 specification: "For SDTM based variables where Core is “Req” (Required), the value of Mandatory should be set to "Yes". For variables where Core is "Exp" (Expected) or “perm” (Permissible) and the sponsor does not require a more restrictive condition, Mandatory should be set to “No”. Variables where Mandatory="Yes" must not have a null value." Lex Jansen Disclaimer: The opinions expressed above are my personal thoughts and may not reflect the opinions of my employer (SAS) or CDISC.

Mandatory column for ADaM variables

What would be the value for the 'Mandatory' column when the variable in cond (conditionally required) in the case of ADaM?

It depends on your programming specifications

Hi Akhil, 

It depends on your programming specifications.If you expect to have non-missing value in this variable for all records in your dataset, then Mandatory attribute will be "Yes". Otherwise, "No".

"Cond" Core does not tell anything in this case and will not help you to make the decision.

Kind Regards,
Sergiy 

 

Mandatory column for ADaM variables

@Akhil - Interestingly that you speak about the "Mandatory" column in the define.xml.
However, define.xml does not have any columns, it is an XML structure.

It is only through the stylesheet that it DISPLAYS as a column in the browser.

You learn this and much more when you take a Define-XML training course from CDISC: https://www.cdisc.org/education/public-training

Best regards,
Jozef
CDISC Define-XML Instructor

As far as I understand the…

As far as I understand the purpose of "Mandatory" is to indicate whether a variable can be blank or not. For ADaM there is no direct relationship between values of the Core attribute and the emptiness of a variable.

Does it mean it is ok to set Mandatory="No" for all variables in an ADaM dataset? If a variable is Mandatory = "Yes" in SDTM, is it necessarily Mandatory = "Yes" in ADaM if copied as predecessor from SDTM (e.g. ADSL.SEX from DM.SEX)?

Mandatory

Mandatory=Yes means that the column must exist in the dataset, and that there must be a non-null (no-blank) value for all the rows in that column, i.e. the cell must always be filled.

In ADaM, must e.g. "STUDYID" not always be filled?

Whether when copied from SDTM, I can't say, that may depend on your specifications.

To understand how Define-XML works, the best thing you can do is to take a (1-day) Define-XML Training from CDISC.

Mandatory attribute

When you go back to the original definition in the Operational Data Model - which Define-XML is an extension to - the definition for the Mandatory attribute states: "The Mandatory flag indicates that the clinical data for an instance of the containing item group would be incomplete without an instance of this type of item. ODM clinical data files that are incomplete in this sense may be considered incomplete for study review and analysis purposes."

Although we can try to map the "Core" attribute in ADaM, SDTM, or SEND to the Mandatory attribute in ODM (or Define-XML), we need to make sure that the "Mandatory" attribute gets a meaningful and correct value. Just setting "Mandatory" = "No" for every AdaM variable does not mean that there are no variables in ADaM that do not require a value. The STUDYID variable that Jozef mentions, or the USUBJID variable are just some examples.

Btw, I always found it very problematic that in ADaM the concept of the Core destination of a 'Required Variable' has a completely different meaning than in SDTM. In ADaM it means that the variable needs to be included in the dataset, but in SDTM it also means that it can not be null for any record. 
The SDTM definition is consistent with the Mandatory = "Yes" definition in ODM.
It's a pity that in ADaM the definition of "Required Variable" was given a different meaning than what was defined in SDTM.

Best,
Lex