| Element Name | Query |
|---|---|
| Parent Elements | Location, ClinicalData, SubjectData, StudyEventData, ItemGroupData, ItemData |
| Element XPath(s) |
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| Element Textual Value | None |
| Usage/Business Rules | |
| Attributes | OID, Source, Target, Type, State, LastUpdateDatetime, Active, Name |
| Child Elements | |
| Usage/Business Rules |
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The Query element represents a request for clarification on a data item collected for a clinical trial; specifically a request from a sponsor or sponsor’s representative to an investigator to resolve an error or inconsistency discovered during data review. Queries can be created manually by roles such as site monitors or data managers or automatically by systems. The full text of the Query exists in the Value child element. The optional Name attribute provide the means to provide a short identifier that can be included in listing or user interfaces.
A Query must be in one of the states listed for the State attribute, and the state diagram below highlights how states can transition through the query workflow. An audit record of the query may be generated as the Query transitions through the workflow. In the Query workflow Open and Candidate are valid start states while Closed, Resolved and Cancelled are valid end states.
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Query Workflow
In order to represent the state of a query in a system independent fashion, then we need to define the workflow of a query in a standard way.
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Query State
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Definition
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Using these definitions;
- Open and Candidate are valid start states
- Closed, Resolved and Cancelled are valid end states
Query Transaction
Used to representation data Query workflow in data management processes and systems - for example sample milestones:
- Create
- Update (e.g. add comment)
- Close (e.g. data marked as correct)
- Resolve (eg response provided and data changed)
- Delete
Query Snapshot
Current state of one or more Queries at a point of time
Query Sources
Types of Queries
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Query Source
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Query Type
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Definition
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