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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.

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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