| Jira |
|---|
| server | Issue Tracker (JIRA) |
|---|
| columnIds | issuekey,summary,issuetype,created,updated,duedate,assignee,reporter,priority,status,resolution |
|---|
| columns | key,summary,type,created,updated,due,assignee,reporter,priority,status,resolution |
|---|
| serverId | 85506ce4-3cb3-3d91-85ee-f633aaaf4a45 |
|---|
| key | ODM-73 |
|---|
|
| Jira |
|---|
| server | Issue Tracker (JIRA) |
|---|
| columnIds | issuekey,summary,issuetype,created,updated,duedate,assignee,reporter,priority,status,resolution |
|---|
| columns | key,summary,type,created,updated,due,assignee,reporter,priority,status,resolution |
|---|
| serverId | 85506ce4-3cb3-3d91-85ee-f633aaaf4a45 |
|---|
| key | ODM-83 |
|---|
|
| Include Page |
|---|
Query Element | Query Element | | Include Page |
|---|
Query Attributes | Query Attributes | 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.
| Include Page |
|---|
| Query Element |
|---|
| Query Element |
|---|
|
| Include Page |
|---|
| Query Attributes |
|---|
| Query Attributes |
|---|
|
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.
| Gliffy Diagram |
|---|
| name | Query Workflow Copy |
|---|
| pagePin | 1 |
|---|
|
Query Workflow
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 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 |
|---|
|
| Include Page |
|---|
| Clinical Data Query Examples - Opening a Query |
|---|
| Clinical Data Query Examples - Opening a Query |
|---|
|
|
| Example |
|---|
| title | Query with Transaction History |
|---|
|
| Include Page |
|---|
| Clinical Data Query Examples - Transaction History |
|---|
| Clinical Data Query Examples - Transaction History |
|---|
|
|