360i: Metadata mapping for SDTM define-xml specification generation
Sam Hume shume@cdisc.org https://www.linkedin.com/in/sam-hume-dsc
SDTM define-xml subteam task framework
- As-Is Metadata Mapping
- the way folks generate Define-XML today to provide a baseline
- To-Be Metadata Mapping
- 360i way of generating today’s artifacts with USDM + BCs + DSS
- Create the recipe for the cookbook and create software to automate
- Long-Term Data Transfer Agreement
- this will be its own standard from the Data Exchange Standards team
- the DTA will provide the base model for Define-JSON
Why are we doing the metadata mapping?
- to create common Define-XML generation software
- to represent a Define-XML recipe for others to create software tools
- to better understand how Define-XML metadata is sourced today
- to identify the metadata gaps limiting Define-XML automation opportunities
Previously demonstrated generating a define-xml
- generated a Define-XML using USDM + BCs + DSS
- but also used Dataset-JSON metadata to specify all datasets and columns
- where do we source the basic Define-XML metadata from?
Tentative resolution
- create define-xml metadata templates for exemplar studies
- use the templates as the basis for automating define-xml spec generation
- provide the means for sponsors to create their own templates
- make the templates available via the CDISC Library API
Dataset metadata partial example
| Attribute | As-Is Source | To-Be Source | Example | Comments |
|---|---|---|---|---|
| OID | Autogenerated | Metadata template | IG.AE | Could also be autogenerated |
| Dataset | IG/Manual | Metadata template | AE | Prespecified list with ability to create X-domains |
| Description | IG/Manual | Metaadata template | Adverse Events | Prespecified domains taken from IG, otherwise manually |
Next steps
- complete the initial mapping draft
- refine define-xml generation software to use mapping
- create a draft metadata template
- continue to review and refine the DTA work
