Page History

...

• A diagram that shows the “prospective” view of the trial (i.e., the view of those participating in the trial). This is similar to the study schema view in that it usually shows a single pool of subjects at the beginning of the trial, with the pool of subjects being split into separate treatment product groups at randomizations and other branches. Such diagrams include the epochs of the trial, and, for each group of subjects and each epoch, the sequence of elements within each epoch for that treatment product group. The arms are also indicated on these diagrams.
• A diagram that shows the “retrospective” view of the trial (i.e., the view of the analyst reporting on the trial). This style of diagram looks more like a matrix; it is also more like the structure of the TA dataset. The retrospective view is arm-centered and shows, for each study cell (epoch/arm combination) the sequence of elements within that study cell. It can be thought of as showing, for each arm, the elements traversed by a subject who completed that arm as intended.
• If the trial is blinded, a diagram that shows the trial as it appears to a blinded participant
• A trial design matrix, an alternative format for representing most of the information in the diagram that shows arms and epochs, and which emphasizes the study cells
• The TA dataset

The Trial Elements ( TE ) dataset contains the definitions of the elements that appear in the Trial Arms ( TA ) dataset. An element may appear multiple times in the TA table because it appears either (1) in multiple arms, (2) multiple times within an arm, or (3) both. However, an element will appear only once in the TE table.

Each row in the TE dataset may be thought of as representing a "unique element" in the same sense of "unique" as a CRF template page for a collecting certain type of data is referred to as "unique page." For instance, a CRF might be described as containing 87 pages, but only 23 unique pages. By analogy, the trial design matrix in Example Trial 1 (see Section 6.5.1.1 Trial Arms) below has 12 study cells, each of which contains 1 element, but the same trial design matrix contains only 5 unique elements, so the TE dataset for that trial has only 6 records.

An element is element is a building block for creating study cells, and an arm is composed of study cells. Or, from another point of view, an arm is composed of elements; that is, the trial design assigns subjects to arms, which comprise a sequence of steps called (elements).

Trial elements represent an interval of time that serves a purpose in the trial and are associated with certain activities affecting the subject. “Week 2 to week 4” is not a valid element. A valid element has a name that describes the purpose of the element and includes a description of the activity or event that marks the subject's transition into the element as well as the conditions for leaving the element.

...