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Description

Specification

Assumptions

The Trial Sets domain is intended to allow the sponsor to define the planned sets of subjects that result as a combination of the experimental factors of interest on a study (including experimental parameters, treatment strategies, inherent characteristics, and sponsor-defined attributes). by providing a list of these sets in the submission, the sponsor can provide information on which sets have various combinations of experimental factors as defined in the trial protocol. This also allows the sponsor to include information about the groups defined in the protocol.

A Trial Set is a collection of subjects that have a common set of parameters defined in the protocol, where those parameters include experimental parameters, treatment strategies, inherent characteristics (such as strain) parameters, and/or sponsor-defined attributes (such as control group designation). There should be no planned parameters of interest that could further subdivide a Trial Set. Each Trial Set can be assigned to a Group. Each Trial Set can be assigned to an Arm, and several Trial Sets can be assigned to one Trial Arm.

A Trial Group is a collection of subjects that have been designated with the same sponsor-defined protocol group code. A Group consists of one or more Sets, so this relationship is hierarchical. Note that the relationship between a Group and an Arm is not hierarchical: a Group may contain subjects from several Arms, one Arm, or part of one Arm. As a result, each Group cannot always be assigned to a single Arm.

A well-defined Trial Set has the following characteristics:

• A Trial Set is a planned set of one or more subjects, possessing experimental factors, treatment factors, or sponsor-defined attributes that differentiate the set from other Trial Sets on the same trial.
• Any subject that is selected for the study will be in one and only one Trial Set (i.e., Trial Sets are mutually exclusive and do not overlap).
• The Trial Set is associated with a single Trial Arm (the set of subjects assigned to a treatment strategy). More than one Trial Set may be associated with the same Arm; however, any Trial Set should be associated with only one Arm only. If a Trial Set appears to be associated with multiple Trial Arms, then it should be further subdivided into Trial Sets, each of which is associated with one Arm through the use of treatment strategy as an experimental factor.

Trial Sets – TX

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Assumptions for Trial Sets (TX) Domain Model