"Repeating", "Reference" and "Mandatory" in define.xml for ADaM

Repeating", "Reference" and "Mandatory"

Dear Christelle,

This is all well explained in the Define-XML Standard specification (https://www.cdisc.org/standards/data-exchange/define-xml). Please read it.
Repeating=Yes: It is expected that there can be more than 1 record per subject (i.e. per USUBJID). This usually means that besides USUBJID there are one or more additional keys for the dataset (provided by the KeySequence attribute in the ItemGroupDef/ItemRef).
Repeating=No. There may only be one record per subject (i.e. per USUBJID). This also means that there is only 1 key defined which is USUBJID.
Mandatory=Yes: There must be at least one record per subject for the given variable.
Mandatory=No: It can be that there are no records for the given variable for a subject.
As explained in the Define-XML specification (and also well explained at CDISC trainings), "Expected" translates to Mandatory=No in the define.xml. Mandatory=Yes is only set for "Required".
A sponsor can however always "promote" this. For example, if the ADaM or SDTM or SEND-IG states that a variable is "Expected", the sponsor is free to promote it to "Required", and than set the variable to Mandatory=Yes in the define.xml. The other way around (demoting) is of course not allowed.

With best regards,
Jozef Aerts
CDISC-Define-XML Team and Define-XML Trainer

Hi Jozef,we also have the…

Hi Jozef,

We also have the same question about this, according to your description "there are one or more additional keys for the dataset (provided by the KeySequence attribute in the ItemGroupDef/ItemRef)"  is the 'one key' except "STUDYID"? in example of DM dataset of the Define-XML Standard specification, it contains 2 keys (STUYID and USUBJID), please find attached snapshot.

Besides for TRIAL DESIGN domains, all of datasets should be Repeating=No, but some of their key variable is more than one (i.e. TA, key with STUDYID,ARMCD,TAETORD), this will also against the 'one key' rule.

Best regards,

Amparo

"Repeating", "Reference" and "Mandatory" in define.xml

Yes, the first key usually is STUDYID. This is meant for the case that all metadata for different studies is stored into a (relational) database.
So, for DM, usually, one has KeySequence=1 for STUDYID, KeySequence=2 for USUBJID.
The choice of the keys is entirely your choice (but it must of course be correct to guarantee uniqueness), so you could also choose to only have 1 key for DM (which would then be USUBJID). But in the examples, we preferred to (also) have STUDYID as the first key, for the use case of setting up a cross-study database.

Hope this helps.

Best,
Jozef

VLM Mandatory attibute

Hi, Jozef:

      In the case of VLM for expected/perm variable, what is the rule to define 'Yes'/'No' value for mandatory? for example, VSORRES where VSTESTCD eq 'WEIGHT' with ItemOID="IT.VS.VSORRES.WEIGHT".

      Thanks,

      Xinhua

VLM Mandatory attibute

Think about it as a transpose, i.e. a "WEIGHT" column is created. If Mandatory="Yes", it is then expected that there is a value (at least one) for "WEIGHT" for each subject.
Does this help?