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Introduction 

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From the beginning, NCI CBIIT has played an instrumental role in supporting the clinical trial process within NCI, with other agencies and groups in NIH and with other collaborating organizations and companies.

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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), 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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Key Use Cases & Requirements

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This section highlight some key use cases that depend on data semantics. These use-cases are used as a representative set to capture the requirements of the clinical trials domain. A comprehensive set of all clinical trails use-cases can be found at https://cabig-kc.nci.nih.gov/CTMS/KC/index.php/CTMS/CCTS_Interoperability_Scenarios_-_Draft

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