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- NCIT_C93490 IAO_0000115 "A plan at a particular point in time for a formal investigation to assess the utility, impact, pharmacological, physiological, and/or psychological effects of a particular treatment, procedure, drug, device, biologic, food product, cosmetic, care plan, or subject characteristic." @default.
- NCIT_C93490 NCIT_NHC0 "C93490" @default.
- NCIT_C93490 NCIT_P106 "Intellectual Product" @default.
- NCIT_C93490 NCIT_P108 "Study Protocol Version" @default.
- NCIT_C93490 NCIT_P207 "C2985700" @default.
- NCIT_C93490 NCIT_P322 "BRIDG" @default.
- NCIT_C93490 NCIT_P322 "CDISC" @default.
- NCIT_C93490 NCIT_P325 "A plan at a particular point in time for a formal investigation to assess the utility, impact, pharmacological, physiological, and/or psychological effects of a particular treatment, procedure, drug, device, biologic, food product, cosmetic, care plan, or subject characteristic. (BRIDG)" @default.
- NCIT_C93490 NCIT_P325 "A plan at a particular point in time for a formal investigation to assess the utility, impact, pharmacological, physiological, and/or psychological effects of a particular treatment, procedure, drug, device, biologic, food product, cosmetic, care plan, or subject characteristic. NOTE(S): The notion of a study includes (but is not limited to) the design, statistical considerations and activities to test a particular hypothesis or answer a particular question that is the basis of the study. The study may be of any type that involves subjects, including prevention, therapeutic, interventional or observational. Subjects may be biological entities (human, animal, specimen, tissue, organ, etc.) or products. The complete notion of the study is represented by the Study class and all its associations which make explicit the details identified in the StudyProtocolDocument." @default.
- NCIT_C93490 NCIT_P325 "A variant or snapshot of the study protocol at a particular point in time. EXAMPLE(S): OTHER NAME(S): NOTE(S): A change in virtually any aspect of a study protocol can trigger the creation of a new study protocol version. The kinds of changes that can trigger creation of a new study protocol version include (but are not limited to) changes to the design, statistical considerations, activities to test a particular hypothesis or answer a particular question that is the basis of the study, characteristics, specifications, objective(s), background, pre-study/study/post-study portions of the plan (including the design, methodology, statistical considerations, organization), supporting documents such as informed consent documents, case report forms (CRFs), regulatory and approval documentation, correlative studies, etc. The complete notion of the study protocol is represented in BRIDG by the classes StudyProtocol, StudyProtocolVersion, StudyProtocolDocument, StudyProtocolDocumentVersion and all their associations. - The StudyProtocol class represents the content of the study protocol which includes characteristics and plan of the study which can be distilled into or abstracted from a version of the study protocol document and can exist even before the information is put into document form. - The StudyProtocolVersion class represents the details of the study protocol that may change over time. - The StudyProtocolDocument class represents the document form of the study protocol and is a grouping of the various study protocol document versions. - The StudyProtocolDocumentVersion class represents the document form of the study protocol version and is the details of the study protocol document that may change over time." @default.
- NCIT_C93490 normalizedInformationContent "100" @default.
- NCIT_C93490 referenceCount "1" @default.
- NCIT_C93490 hasExactSynonym "Study Protocol Version" @default.
- NCIT_C93490 hasExactSynonym "StudyProtocolVersion" @default.
- NCIT_C93490 inSubset NCIT_C132298 @default.
- NCIT_C93490 inSubset NCIT_C132309 @default.
- NCIT_C93490 inSubset NCIT_C159501 @default.
- NCIT_C93490 inSubset NCIT_C159503 @default.
- NCIT_C93490 inSubset NCIT_C188693 @default.
- NCIT_C93490 inSubset NCIT_C188698 @default.
- NCIT_C93490 inSubset NCIT_C188700 @default.
- NCIT_C93490 inSubset NCIT_C61410 @default.
- NCIT_C93490 type Class @default.
- NCIT_C93490 isDefinedBy ncit.owl @default.
- NCIT_C93490 label "Study Protocol Version" @default.
- NCIT_C93490 subClassOf NCIT_C20181 @default.
- NCIT_C93490 subClassOf NCIT_C25714 @default.
- NCIT_C93490 subClassOf NCIT_C93490 @default.