By now, many of you have heard about the CDISC SHARE project. For those of you that haven’t, this new initiative seeks to develop multi-dimensional, machine-readable clinical study metadata that is based on ISO data standards and the BRIDG model. In short we want to change the way we develop standards to an approach that focuses on precise definitions, terminology and metadata (BRIDG, datatypes, variable names, etc.) to take a date element/concept from the clinical protocol, through collection, analysis and submission. To quote Dave Iberson-Hurst, CDISC is, “moving from the implicit world of data standards to the explicit world of data standards”.
Briefly, the project is divided into two teams, team 1 - Content alignment team and team 2 - Metadata Model, Governance and Requirements. Team 1 is focused on semantic alignment of SDTM and CDASH. We are working to ensure that definitions used are the same for a given variable in both standards. To do this, the team has created a bridging spreadsheet with which to compare and discuss each variable and data collection field. The intention is that harmonized SDTM and CDASH safety content will be the first content included in the CDISC SHARE Library. Team 2 is focused on the development and testing of a metadata model (MM) and from this work the creation of governance for the inclusion and maintenance of metadata. During the F2F meeting held earlier this month, a major project milestone was met when the team reviewed and tested a draft MM.
NCI has agreed to partner with CDISC in the development of CDISC SHARE Library. To facilitate this both CDISC SHARE teams will contribute system/tool requirements to NCI who will include these in semantic infrastructure update project. An iterative approach will be adopted; wherein NCI incrementally releases new tools that the CDISC SHARE teams can test as they become available.
Where are we today?
- 2 active & productive teams are engaged in development.
- Learning about the project is now occurring at a faster rate. The teams are getting more comfortable with MM (i.e. layers, core model, templates).
- Harmonized safety content is coming along nicely.
- We now have a draft MM
- Requirements package 1 done and sent to NCI
- Requirements package 2 will flow from testing and refining the MM
- Foundational work is being done to ensure that the teams are ready when NCI incrementally releases new tools & functionality.
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