Spec:
Vlm:
Acrf:
Vlm是什么?
是define.xml里的一种用于表示CDISC标准中独立定义的变量之间关系的实施方法。
什么时候考虑使用vlm?
Define-XML 2.0 Specification:
•Used where the dataset variable metadata does not provide sufficient detail to support data review and analysis
•Value Level Metadata should be provided when there is a need to describe differing metadata attributes for subsets of cells within a column
使用Vlm好处是什么?
Value level = Row level,每条记录提供的细节可以support clear, unambiguous documentation.
对于Reviewer:提供研究数据相关的有用的信息。
对于programmer:描述某些变量该如何编程。
Vlm和CT应该是预先根据crf就决定好的,如果数据中出现了unexpected values or new concepts,那么就可以进一步检查Vlm和CT。
可以发现出有问题的值,然后再做进一步的检查。
Define-XML 2.0 Specification:
•Value Level Metadata should be applied when it provides information useful for interpreting study data. It need not be applied in all cases.
•It is left to the discretion of the creator when it is useful to provide Value Level Metadata and when it is not.
哪里使用VLM?
Standard Use Cases(从下图总结,可结合我文末链接文章阅读。)
1.Findings Test Codes note: IE exception
2.Supplemental Qualifiers(QVAL)系统自动生成
3.Multiple Origins
Define-XML 2.0 Specification / Phuse guidance:
•When deciding whether or not to define VLM, a good rule of thumb is that if providing VLM for a variable would mean each value has a codelist containing only one CodeList Item, it is probably more appropriate to define a codelist rather than a valuelist. [ This is the case with --TEST and --TESTCD Variables]
比如LBTEST只需要给codelist,而LBORRES就要给vlm。
Note:
如果是一些很重要的数据,比如一些Role为topic变量也可以为其提供vlm,不仅仅是限制于findingsdomains的result变量。比如interventions的cmtrt。
一般来说finding类的最重要的变量就是orres,即result,当我们在描述result的时候通常使用TESTCD,但是比如lborres往往会有上百条testcd。为了简洁,其余变量无需重复使用vlm。但是一些变量如果有特别的需求也可以使用,比如表达lborres数据来源。
拓展:
Codelist:
When a variable has value-level specified and value-level items have different codelists associated with them, the codelists should be provided on the value-level definition.
Define-XML 2.0 Specification:
When a variable has value-level metadata specified and all value-level definitions have the same codelist associated with them, the codelist should be provided on the variable-level.