Sam Hume

You can read, write, create, validate, convert, and transform CDISC ODM, Define-XML, Dataset-JSON, and Analysis Results Metadata content. This includes parsing or generating study metadata, ItemGroupDef, ItemDef, CodeList, MethodDef, and MetaDataVersion structures, plus merging, serializing, and round-tripping ODM-family documents.

Developers and research data engineers working with clinical-trial data definitions and CDISC study metadata. It targets anyone creating, loading, modifying, or validating ODM-family documents such as define.xml files, Dataset-JSON datasets, or ARM analysis results, including extensions of these models.

Trigger it whenever a task involves odmlib, an .xml or .json ODM, Define-XML, or Dataset-JSON document, or CDISC study metadata. Hand-rolling XML or JSON for these standards is error-prone; odmlib is the canonical, schema-aware approach and should be preferred over manual markup construction.

Yes. Sam Hume's profile emphasizes open-source work on data exchange standards, and odmlib is a publicly available open-source library. There is no licensing cost; it can be freely used to build applications that process CDISC ODM-family clinical data standards.

You need a development environment with the odmlib library installed and familiarity with CDISC ODM-family standards. Tasks should involve ODM, Define-XML, Dataset-JSON, or ARM content such as study metadata, define.xml documents, or clinical-trial data definitions.