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The Protocol element lists the kinds of study events that can occur within a specific version of a study. All clinical data must occur within one of these study events.

Note: ODM can be used to provide a "common metadata dictionary" for metadata used across studies, and such a metadata dictionary may include a study that does not contain a protocol definition.

The study structure (i.e. arms and epochs) is described by the contents of the StudyStructure element.

Study design parameters (e.g., study indication, intervention model, minimum and maximum number of participants) are described in the StudySummary element.

Study cells, study elements, and subelements are described by instances ODM-51 - Getting issue details... STATUS of StudyEventGroupDef.

The overall workflow for the study as a whole must be referenced from the Protocol element. Subworkflows can then be defined by generating StudyEventGroupDefs that then reference a WorkflowDef representing the subworkflow.

Element NameProtocol
Parent ElementMetaDataVersion
Element XPath(s)

/ODM/Study/MetaDataVersion/Protocol

Element Textual ValueNone
AttributesNone

Child Elements 

(Description?, StudySummary?,  StudyStructure?, TrialPhase?, StudyTimings?, StudyIndications?, StudyInterventions?,  StudyObjectives? StudyEndPoints?, StudyTargetPopulation?, StudyEstimands?, InclusionExclusionCriteria?, StudyEventGroupRef*, WorkflowRef?, Alias*)

Usage/Business Rules

  • Other Information:
    • ODM can be used to provide a "common metadata dictionary" for metadata used across studies, and such a metadata dictionary may include a study that does not contain a protocol definition.

    • The study structure (i.e. arms and epochs) is described by the contents of the StudyStructure element.

    • Study design parameters (e.g., study indication, intervention model, minimum and maximum number of participants) are described in the StudySummary element.

    • Study cells, study elements, and subelements are described by instances of StudyEventGroupDef.

    • The overall workflow for the study as a whole must be referenced from the Protocol element. Subworkflows can then be defined by generating StudyEventGroupDef elements that then reference a WorkflowDef representing the subworkflow.


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