Define.xml for ADaM

DEFINE.XML FOR ADAM

For define.xml version 1, I suggest you take a look at how this was done in the updated Version of SDTM/ADaM Pilot Submission Package (2013). See: http://www.cdisc.org/sdtm-adam-pilot-project This example contains Parameter Value Level Metadata, which has always been part of the define.xml, and never a separate file. Do notice that this example contains an extension for Analysis Results Metadata, which is not part of the define.xml version 1. Currently the ADaM metadata team, together with the CDISC XML technologies team is working on the Analysis Results Metadata extension based on define.xml version 2 (Define-XML v2.0). As far as support for Value Level Metadata for ADaM, you may want to take a look at SAS Clinical Standards Toolkit (CST), whose new version 1.5 will be released later this month. CST 1.5 support value Level Metadata for SDTM and ADaM in define.xml version 1. Lex Jansen Disclaimer: I am a SAS employee and developer of CST. Views expressed here are my own.

Define.xml for ADaM

Thanks for the answer,

 

I guess we are speacking here of two different thing. It is clear that value-level-metadata was always part of the define.xml.

My problem is, that in earlier CDISC documents the analysis-value-metadata.xls and analysis-variable-metadata.xls were described as two different files. Based on them it was ok to generate a define.xml. Now the actual CDISC Model Guideline, version 2.1, describes only one document analysis-variable-metadata which includes the analysis-value-metadata. Currently we do not have any ideas how based on this one document the define.xml should work. We had a look at the pilot project as well and did not find the description of the files which were the basis for the define.xml. It looks like two documents: value-metadata and variable-metadata were used, but we could not find where it is exactly stated.

Thanks,

Natalie

Define.xml for ADaM

Natalie, I'm not sure exactly which Excel spreadsheets you are describing (analysis-value-metadata.xls and analysis-variable-metadata.xls). I think what you are describing with "one document analysis-variable-metadata which includes the analysis-value-metadata" is table 5.2.2.1 in the ADaM 2.1 Model document. This table just illustrates how variable metadata and value metadata could be specified. It indeed mixes variable metadata and value level metadata in one table. This could also have been specified in 2 tables (which I personally would prefer). The define.xml will not have parameter values like "*DEFAULT*" and "*ALL*". Table 5.2.2.1 is not describing the actual define.xml, or even how the define.xml will be displayed. How you specify the metadata that forms the basis of the define.xml, and whether you combine value-metadata and variable-metadata in your specification, is not part of the define.xml standard. Some people will specify this in Excel spreadsheets, but others might have an MDR (MetaData Repository) for this kind of metadata. How this metadata is managed, and in what format, is part of your internal process. How this metadata will be stored in the define.xml is part of the define.xml standard. I hope this helps. Best, Lex

Define.xml for ADaM

Thank you for your answer.

Kind regards,

Natalie