From the beginning, NCI CBIIT has played an instrumental role in supporting the clinical trial process both within NCI, and with other agencies and groups in NIH and other collaborating organizations and companies. A significant part of this role is in providing a foundational basis for these stakeholders to leverage standard terminologies and metadata, and a standards-based framework, in defining semantic entities related to clinical trials such as forms, protocols, eligibility criteria etc. Semantic Infrastructure 2.0 will expand on these use cases, in order to both facilitate data collection within clinical trials, and enable the information collected to interoperate with other modalities in caBIG® such as the life sciences domain, to advance knowledge in disease processes and treatments. NCI CBIIT also plays a leading role in the BRIDG project, which will form a significant basis for the layered approach to metadata and terminology we will adopt in the Semantic Infrastructure 2.0.
As a starting point, requirements specific to the clinical trials domain will be collected from the recent Semantic Infrastructure Requirements Elicitation effort, from the NCI CBIIT in-house terminology and metadata curation teams, and from related projects at NCI CBIIT such as the CTRP, caBIG® Clinical Information Suite, caBIG® Clinical Trial Suite, Janus, and other projects. We are also collecting requirements from external stakeholders including government agencies, standard development organizations (SDOs), organizations and companies, such as CDISC (especially the SHARE project) and HL7. Community input based on this roadmap documents, and the forms and modeling workgroup in the Semantic Infrastructure 2.0 Inception effort, will form another significant source of requirements from this domain.
