Clinical Observations Interoperability Functional Requirements
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List of Functional Requirements with associated Use Case for enabling interoperability and sharing of clinical observations across EMRs and Clinical Trial Systems
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Req#Requirement DescriptionUse CasesSystems
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Patient RecruitmentClinical Trial Data CollectionDrug Safety SurveillanceClinical Trial Data CollectionEpidemeologyDocument Management for Clinical TrialsOutcomes ResearchSupport Regulatory ApprovalVirtual Phase IV TrialsAudit Medication WorkflowPost Launch Drug UseAdaptive Clinical TrialsElectronic Medical Record (EMR)Clinical Trials Management System (CTMS)
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1Data Capture and Interfaces
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2Identity and Confidentiality
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3Data ContentXXX
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4Data Exchange and InteroperabilityXXX
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5Protocol SpecificationXX
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6Data RetrievalXXX
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6Data Access/Authentication/Audit & Logging
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7Data Quality/Data Integrity
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8Data Storage
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Functional Requirements
Data Content
Data Interoperability
Data Retrieval
Protocol Specification