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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. Requirements are also being collected from external stakeholders including government agencies, standard development organizations (SDOs), organizations and companies such as CDISC (especially the SHARE project (cdisc.org)), and HL7. Community input based on this roadmap document, and the forms and modeling workgroup in the Semantic Infrastructure 2.0 Inception effort, will form another significant source of requirements from the clinical trials domain.

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