Preferred Label : Study Protocol Version;
NCIt related terms : StudyProtocolVersion;
NCIt definition : 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.;
Alternative definition : CDISC: 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); BRIDG 3.0.3: 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.; BRIDG 5.3: 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.;
Origin ID : C93490;
UMLS CUI : C2985700;
Semantic type(s)
- concept_is_in_subset
