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 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.
| Element Name | Query |
|---|---|
| Parent Elements | Location, ClinicalData, SubjectData, StudyEventData, ItemGroupData, ItemData |
| Element XPath(s) |
|
| Element Textual Value | None |
| Usage/Business Rules | |
| Attributes | OID, Source, Target, Type, State, LastUpdateDatetime, Active, Name |
| Child Elements | |
| Usage/Business Rules |
|
| Attribute | Schema Type or Enumeration Values | Usage | Definition | Business Rule(s) |
|---|---|---|---|---|
| OID | oid | Query unique identifier |
| |
| 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 | Indicates whether Is the Query was raised manually by a user or automatically via an edit check. | |
| State | Candidate | Open | Answered | Closed | Cancelled | Resolved | Status of the Query | ||
| LastUpdateDatetime | datetime | When was this Query updated? Will correspond to the creation date or the last updated date? | ||
| Name | name | Optional | Name for a query that can be used to identify the query in a listing or user interface. |
Query Workflow
A Query must be in 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; Closed, Resolved and Cancelled are valid end states.
In order to represent the state of a query in a system-independent fashion, the workflow of a query needs to be defined in a standard way.
Query State | Definition |
|---|---|
| Candidate | Query 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. |
| Open | Query has been raised by initiator to site staff |
| Answered | Response provided by site staff, ready for review by data management or system software |
| Closed | Query 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 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; for example, sample milestones:
- Create
- Update (e.g., add comment)
- Close (e.g., data marked as correct)
- Resolve (e.g., response provided and data changed)
- Delete
Query Snapshot
Current state of 1 or more Queries at a point of time
Query Sources
Types of Queries
Query Source | Query Type | Definition |
|---|---|---|
| System to Site | System | Query raised automatically by data capture system in response to data quality issue (for example) |
| Data Management to Site | Manual | Query raised by data manager for address by site personnel |
| Site Monitor to Site | Manual | Query raised by site monitor for address by site personnel |
| Coding System to Site | Manual | System | Query raised by coding system requiring clarification from site |
| Safety Reviewer to Site | Manual | Query raised by safety reviewer (often in relation to addressing a serious adverse event) |
Example: Opening a Query
Opening a Query
<?xml version="1.0" encoding="UTF-8"?> <ODM FileType="Snapshot" Granularity="AllClinicalData" CreationDateTime="2021-03-10T13:36:51.668-00:00" FileOID="8ca17c08-5a6f-4fcb-bf82-b4fa46fe6d99" ODMVersion="2.0" xmlns="http://www.cdisc.org/ns/odm/v2.0"> <ClinicalData StudyOID="EX001" MetaDataVersionOID="1010"> <SubjectData SubjectKey="1001" TransactionType="Insert"> <SiteRef LocationOID="WestWing"/> <StudyEventData StudyEventOID="Visit1"> <ItemGroupData ItemGroupOID="VISDT" ItemGroupRepeatKey="1"> <ItemData ItemOID="VISDT"> <Value>2200-10-01</Value> <Query Source="System" Type="System" OID="A529A2F2-F896-4AF7-AD4D-11B7110727BC" State="Open" LastUpdateDatetime="2021-03-10T13:36:51.668-00:00" Name="VISDT_NOT_FUTURE"> <Value>Value 2200-10-01 is in the future, please correct</Value> <AuditRecord> <UserRef UserOID="SYSTEM"/> <LocationRef LocationOID="WestWing"/> <DateTimeStamp>2021-03-10T13:36:51.668-00:00</DateTimeStamp> </AuditRecord> </Query> </ItemData> </ItemGroupData> </StudyEventData> </SubjectData> </ClinicalData> </ODM>
Example: Query with Transaction History
Query with Transaction History
<?xml version="1.0" encoding="UTF-8"?>
<ODM FileType="Snapshot" Granularity="AllClinicalData" CreationDateTime="2021-02-10T13:36:51.668-00:00" FileOID="8ca17c08-5a6f-4fcb-bf82-b4fa46fe6d99" ODMVersion="2.0" xmlns="http://www.cdisc.org/ns/odm/v2.0">
<ClinicalData StudyOID="EX001" MetaDataVersionOID="1010">
<SubjectData SubjectKey="1001" TransactionType="Insert">
<SiteRef LocationOID="WestWing"/>
<StudyEventData StudyEventOID="Visit1">
<ItemGroupData ItemGroupOID="VISDT" ItemGroupRepeatKey="1">
<ItemData ItemOID="VISDT">
<Value>2020-10-01</Value>
<AuditRecord>
<UserRef UserOID="CRC01"/>
<LocationRef LocationOID="TeaPot1"/>
<DateTimeStamp>2021-02-14T13:36:51.668-00:00</DateTimeStamp>
<ReasonForChange>Entered 2020-10-01</ReasonForChange>
</AuditRecord>
<Query Source="System" Type="System" OID="A529A2F2-F896-4AF7-AD4D-11B7110727BC" State="Closed" LastUpdateDatetime="2021-03-10T13:36:51.668-00:00" Name="VISDT_NOT_FUTURE">
<Value>Value is in the future, please correct</Value>
<AuditRecord>
<UserRef UserOID="SYSTEM"/>
<LocationRef LocationOID="WestWing"/>
<DateTimeStamp>2021-02-10T13:36:51.668-00:00</DateTimeStamp>
<ReasonForChange>Edit check raised</ReasonForChange>
</AuditRecord>
<AuditRecord>
<UserRef UserOID="CRC01"/>
<LocationRef LocationOID="TeaPot1"/>
<DateTimeStamp>2021-02-12T13:36:51.668-00:00</DateTimeStamp>
<ReasonForChange>Reviewed</ReasonForChange>
</AuditRecord>
<AuditRecord>
<UserRef UserOID="CRC01"/>
<LocationRef LocationOID="TeaPot1"/>
<DateTimeStamp>2021-02-14T13:36:51.668-00:00</DateTimeStamp>
<ReasonForChange>Updated value to 2021-10-01 [Status Changed to "Answered"]</ReasonForChange>
</AuditRecord>
<AuditRecord>
<UserRef UserOID="SYSTEM"/>
<LocationRef LocationOID="WestWing"/>
<DateTimeStamp>2021-02-14T13:37:51.668-00:00</DateTimeStamp>
<ReasonForChange>Edit check raised [Status Changed to "Open"]</ReasonForChange>
</AuditRecord>
<AuditRecord>
<UserRef UserOID="CRC01"/>
<LocationRef LocationOID="TeaPot1"/>
<DateTimeStamp>2021-02-16T13:36:51.668-00:00</DateTimeStamp>
<ReasonForChange>Reviewed</ReasonForChange>
</AuditRecord>
<AuditRecord>
<UserRef UserOID="CRC01"/>
<LocationRef LocationOID="TeaPot1"/>
<DateTimeStamp>2021-02-18T13:36:51.668-00:00</DateTimeStamp>
<ReasonForChange>Updated value to 2020-10-01 [Status Changed to "Answered"]</ReasonForChange>
</AuditRecord>
<AuditRecord>
<UserRef UserOID="SYSTEM"/>
<LocationRef LocationOID="WestWing"/>
<DateTimeStamp>2021-02-18T13:36:51.668-00:00</DateTimeStamp>
<ReasonForChange>Edit check resolved by response [Status Changed to "Resolved"]</ReasonForChange>
</AuditRecord>
<AuditRecord>
<UserRef UserOID="SYSTEM"/>
<LocationRef LocationOID="WestWing"/>
<DateTimeStamp>2021-02-25T13:36:51.668-00:00</DateTimeStamp>
<ReasonForChange>Edit check auto-closed [Status Changed to "Closed"]</ReasonForChange>
</AuditRecord>
<AuditRecord>
<UserRef UserOID="INV01"/>
<LocationRef LocationOID="TeaPot1"/>
<DateTimeStamp>2021-03-10T13:36:51.668-00:00</DateTimeStamp>
<ReasonForChange>Signed Subject CRF</ReasonForChange>
</AuditRecord>
</Query>
</ItemData>
</ItemGroupData>
</StudyEventData>
</SubjectData>
</ClinicalData>
</ODM>