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Element NameQuery
Parent ElementsLocationClinicalData, SubjectData StudyEventDataItemGroupDataItemData
Element XPath(s)

/ODM/AdminData/Location/Query

/ODM/ClinicalData/Query

/ODM/ClinicalData/SubjectData/Query

/ODM/ClinicalData/SubjectData/StudyEventData/Query

/ODM/ClinicalData/SubjectData/StudyEventData/ItemGroupData/Query

/ODM/ClinicalData/SubjectData/StudyEventData/ItemGroupData/Query

/ODM/ReferenceData/ItemGroupData

/ODM/ClinicalData/ItemGroupData 

Element Textual ValueNone
Usage/Business Rules
AttributesOID, Source, Target, Type, State, LastUpdateDate, Active, Name
Child Elements(ValueAuditRecord?)


Attributes:

Source(System | Data Management | Site Monitor | Coding System | Safety Reviewer)
Origin of the Query.
Targettext(optional)Element upon which the Query is raised. The parent element is the Target when the Target attribute is omitted. 
Type(Manual | System | Manual/System)(optional)Is the Query raised manually by a user or automatically via an edit check.
OIDoid
Query unique identifier
State(Candidate | Open | Answered | Closed | Cancelled | Resolved)
What is the current state of this Query?
LastUpdateDatedatetime
When was this Query updated? Will correspond to the creation date or the last updated date?
Active(Yes | No)
Is this query active?
Namename(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. 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.

Query Workflow Copy

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.

Query State

Definition

CandidateQuery visible to Sponsor Staff, not visible to Site Staff; if the Candidate Query is deemed actionable then it can be sent to the Site (Status goes to Open); otherwise the Query is Cancelled
OpenQuery has been raised by initiator to Site Staff
AnsweredResponse provided by Site Staff, ready for review by Data Management or System Software
ClosedQuery for which response has been provided, which has been subsequently reviewed by Data Management or by automated review of response (which may be changing the conflicting data point so it is no longer non-conformant)
CancelledQuery has been removed without requiring response
ResolvedQuery 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

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 

Query Source

Query Type

Definition

System to SiteSystemQuery Raised automatically by Data Capture System in response to Data Quality Issue (for example)
Data Management to SiteManualQuery Raised by Data Manager for Address by Site Personnel
Site Monitor to SiteManualQuery Raised by Site Monitor for Address by Site Personnel
Coding System to SiteManual/SystemQuery raised by Coding System requiring clarification from Site
Safety Reviewer to SiteManualQuery raised by Safety Reviewer (often in relation to addressing a SAE)

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