Planned Clinical Study Activity

Definition 1

Any activity specified in a clinical study protocol that is anticipated to be performed during the execution of the study. (NCI Thesaurus)

Definition 2

An activity that is intended to occur or start at some point in the context of a particular study. EXAMPLE(S): Pregnancy tests are planned for StudySubjects who are females of childbearing potential. NOTE(S): A PlannedActivity may be a container of other activities and have a complex structure involving components, options and contingencies using the associated relationship classes. This structure allows BRIDG 3.0 to represent concepts in previous versions of BRIDG such as StudyCells, StudySegments and StudySubjectEncounters. A PlannedActivity could also be thought of as an activity at a particular stage in the business process in which the activities occur, i.e., in the "planned" stage rather than the "scheduled" stage or the "performed" stage. An instance of a planned activity is not assigned to a particular StudySubject, but to a "kind of" StudySubject. (NCI Thesaurus/BRIDG)

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Specifies whether a change in an activity, event or entity is planned or not.

Planned Arm Code

A character or string that represents a planned arm of a trial.

Planned Activity Target Accrual Number Range

A range of integers specifying the minimum and maximum number of subjects to be accrued for the planned activity.

Planned Activity Study Day Range

The relative timing for a planned activity expressed as the number of days offset from the study-defined reference activity (e.g. , date…

Planned Activity Repeat Quantity

The number of times the planned activity occurs.