Body:
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Attributes:
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The
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Query
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Contained in:
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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 individuals 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.
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| Query Element |
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| Query Element |
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| Query Attributes |
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| Query Attributes |
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Query Workflow
A Query must be in one 1 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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| name | Query Workflow Copy |
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| pagePin | 1 |
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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 needs to be defined in a standard way.
Query State | Definition |
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| Candidate | Query visible to |
Sponsor Staff| sponsor staff, not visible to |
Site Staff| site staff; if the Candidate |
Query | query is deemed actionable then it can be sent to the |
Site Status | status goes to Open); otherwise the |
Query | query is Cancelled. |
| Open | Query has been raised by initiator to |
Site Staff| site staff |
| Answered | Response provided by |
Site Staff| site staff, ready for review by |
Data Management or System Software| data management or system software |
| Closed | Query for which response has been provided, which has been subsequently reviewed by |
Data Management | data management or by automated review of response (which may be changing the conflicting data point so it is no longer |
non-conformant| nonconformant) |
| Cancelled | Query has been removed without requiring response |
| Resolved | Query has a response and no further action is required on it |
Using these definitions;
- Open and Candidate are valid start states
- Closed, Resolved, and Cancelled are valid end states
Transitions are shown in the diagram above, but are not currently modelled in the ODM Schema. The correct location for this would be on the AuditRecord element. In a future release there will be an element added to the AuditRecord that enumerates the state transition (eg Candidate → Open).
Query Transaction
Used to representation data Query workflow in data-management processes and systems
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; for example, sample milestones:
- Create
- Update (e.g., add comment)
- Close (e.g., data marked as correct)
- Resolve (
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- e.g., response provided and data changed)
- Delete
Query Snapshot
Current state of
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1 or more Queries at a point of time
Query Sources
Types of Queries
Query Source | Query Type | Definition |
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| System to Site | System | Query |
Raised Data Capture System | data capture system in response to |
Data Quality Issue | data quality issue (for example) |
| Data Management to Site | Manual | Query |
Raised Data Manager Address Site Personnel| site personnel |
| Site Monitor to Site | Manual | Query |
Raised Site Monitor Address Site Personnel| site personnel |
| Coding System to Site | Manual |
/ Coding System | coding system requiring clarification from |
Site| site |
| Safety Reviewer to Site | Manual | Query raised by |
Safety Reviewer | safety reviewer (often in relation to addressing a |
SAE)| Example |
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| Clinical Data Query Examples - Opening a Query |
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| Clinical Data Query Examples - Opening a Query |
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| title | Query with Transaction History |
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| Clinical Data Query Examples - Transaction History |
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| Clinical Data Query Examples - Transaction History |
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