Preferred Label : Study Protocol Document Version;
NCIt related terms : StudyProtocolDocumentVersion;
NCIt definition : A representation of a particular edition or snapshot of a document containing a study
protocol as it exists at a particular point in time.;
Alternative definition : BRIDG 3.0.3: A representation of a particular edition or snapshot of a document containing
a study protocol as it exists at a particular point in time. EXAMPLE(S): Version 3
of a breast cancer protocol. NOTE(S): A version of the study protocol represents the
characteristics and plan of the study which can be distilled into or abstracted from
a version of the study protocol document. A StudyProtocolDocumentVersion is related
to other supporting document versions involved in the study, including (but not limited
to) informed consent documents, case report forms (CRFs), regulatory and approval
documentation, correlative studies, etc. via the inherited association to DocumentVersionRelationship.
The term Amendment needs to be disambiguated since it sometimes refers to the amended
version of the protocol (BRIDG's StudyProtoclDocumentVersion) and other times refers
to the summary of changes.; BRIDG 5.3: A variant or snapshot of the study protocol document at a particular point
in time. EXAMPLE(S): Version 3 of a breast cancer protocol document. OTHER NAME(S):
Amendment NOTE(S): A study protocol document version is one component of the overall
concept of a study protocol. 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. The term Amendment needs to be disambiguated since it sometimes refers
to the amended version of the protocol (StudyProtocolDocumentVersion) and other times
refers to the summary of changes (AmendmentChangeSummaryVersion).;
Origin ID : C93489;
UMLS CUI : C2985699;
Semantic type(s)
- concept_is_in_subset
