Each SDTM dataset starts as a specification in the ryze platform. Our dataset design tools contain the CDISC SDTM metadata as templates. So ryze builds your datasets using CDISC SDTM rules. The templated metadata is then extended using the selected CDISC NCI controlled terms, and any supplemental qualifiers, value level metadata etc. is added. And our CDISC validator makes checks as you work.
This specification document forms both the guidance for programming teams and also the Define-XML metadata for the dataset deliverable. The dataset specification is saved in ryze, alongside the EDC build documents. This gives a central place for all your study metadata. Once the basic SDTM dataset structure is agreed, additional programmer instructions are added to each variable, domain, etc. within the electronic specification. Any updates or clarifications are immediately captured in ryze, and the software generated programmer specifications (e.g. excel sheets) are automatically updated. And the same metadata is used for the submission Define-XML, which is automatically generated.
The SDTM Define-XML is independent of the clinical datasets (and data programmer). Therefore it can be used as a benchmark to check the dataset content against, to ensure compliance with the CDISC SDTM standard.
Remember, if the Define-XML metadata is extracted from the clinical datasets, this is not suitable for use as a validation specification. Any errors in the datasets will just be recreated in the Define-XML, removing the ability to provide an independent quality check.