Kerstin Forsberg has written an article discussing a presentation she and Frederik Malfait gave regarding the use of semantic models for CDISC-based standard and metadata management, pointing to case studies at AstraZeneca and Roche. She writes, “In AstraZeneca we have a new program called Integrative Informatics (i2) establishing the components required to let a linked data cloud grow across R&D. A key component is the URI policy for how to make for example a Clinical Study linkable by giving it a URI, that is a Uniform Resource Identifier, e.g. This is an identifier for a clinical study with the study code D5890C00003 that should be persistent and not dependent on any system. In the same way we will give guidance on how to use URI:s to make other key entities such as Investigator and Lab linkable.”

She continues, “Frederik described the schema, content and architecture of Roche Biomedical MDR. And then he went through a demo using a RDF representation of a CDISC standard example and of an internal Roche standard (you will find the screenshots from the demo in the slides)… In the slides you can see that Frederik had to transform CDISC standards into RDF using a schema he developed for Roche and give them URI:s in a Roche namespace (e.g. for one of the data elements). This is not a ideal way, instead we would like CDISC to provide these. Hence the drive from our leadership in Roche and AstraZeneca for Frederik and myself to push back to CDISC. Below a draft list of proposals to CDISC.”

See the list of proposals here.

Image: Courtesy Kerstin Forsberg