Body:
| (Value, AuditRecord?) |
Attributes:
| Source | (System | Data Management | Site Monitor | Coding System | Safety Reviewer) | Origin of the Query. | |
| Target | text | (optional) | Element upon which the Query is raised. The parent element is the Target when the Target attribute is omitted. |
| Type | (Manual | System) | (optional) | Is the Query raised manually by a user or automatically via an edit check. |
| OID | oid | Query unique identifier | |
| State | (Candidate | Open | Answered | Closed | Cancelled | Resolved) | What is the current state of this Query? | |
| LastUpdateDate | datetime | When was this Query updated? Will correspond to the creation date or the last updated date? | |
| Active | boolean | Is this query active? | |
| Name | name | (optional) | Name for a query that can be used to identify the query in a listing or user interface. |
Contained in:
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. 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.