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Clinical Trial Epoch
Definition 1
A portion of a study containing one or more study segments with a consistent objective such as screening subjects or treating disease. (NCI Thesaurus)
Definition 2
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. (NCI Thesaurus/BRIDG)
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