Preferred Label : Clinical Trial Epoch;
NCIt synonyms : Epoch;
NCIt related terms : Study Epoch;
NCIt definition : A portion of a study containing one or more study segments with a consistent objective
such as screening subjects or treating disease.;
Alternative definition : BRIDG 5.3: One of a set of ordered partitions of a subject's participation in a study.
An Epoch represents a state within a study such that subjects in separate arms within
that state are comparable. Each epoch serves a purpose in the study as a whole, typically
exposing the subject to a treatment or preparing them for a treatment, or gathering
post-treatment data. Activities and activity results control the subject's movement
from one epoch to another. EXAMPLE(S): A study designed to assess the effects of treatments
might have 3 epochs. A Screening Epoch in which subjects' eligibility is determined
and baseline measurements are made. A Treatment Epoch during which treatments are
given and effects of treatment are assessed. A Follow-up Epoch during which post-treatment
assessments are conducted. OTHER NAME(S): NOTE(S): A subject moves from one epoch
to another and can only be in one epoch at a time. The subject can only move to an
epoch with a greater sequenceNumber. Activities in the same epoch but a different
arm need not be similar in time and pattern. Subjects in different arms will not necessarily
pass through the same epochs.; BRIDG 3.0.3: One of a set of ordered partitions of an experimental unit's participation
in a study. An Epoch represents a state within a study such that subjects in separate
arms within that state are comparable. Each epoch serves a purpose in the trial as
a whole, typically exposing the subject to a treatment or preparing them for a treatment,
or gathering post-treatment data. Activities and activity results control the subject's
movement from one epoch to another. EXAMPLE(S): A study designed to assess the effects
of treatments might have 3 epochs. A Screening Epoch in which subjects' eligibility
is determined and baseline measurements are made. A Treatment Epoch during which treatments
are given and effects of treatment are assessed. A Follow-up Epoch during which post-treatment
assessments are conducted. NOTE(S): A subject moves from one epoch to another and
can only be in one epoch at a time. The subject can only move to an epoch with a greater
sequenceNumber. Activities in the same epoch but a different arm need not be similar
in time and pattern. Subjects in different arms will not necessarily pass through
the same epochs.; CDISC-GLOSS: Planned interval of time in the conduct of a study wherein an activity
is specified and consistent, e.g., specific treatment dose or study activity such
as Screening. NOTE: A CDISC variable used in the SDTM model to indicate a time period
defined in the protocol with a study-specific purpose. See also arm, visit, phase
(within a study).; CDISC: A named time period defined in the protocol, wherein a study activity is specified
and unchanging throughout the interval, to support a study-specific purpose.;
Origin ID : C71738;
UMLS CUI : C2347803;
Semantic type(s)
- concept_is_in_subset
