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Queries follow a defined lifecycle from creation through resolution. Understanding this lifecycle helps ensure efficient query management.

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Query States

Queries progress through these states:
StateDescription
OpenQuery raised, awaiting response
AnsweredSite has responded
ClosedQuery resolved

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Lifecycle Flow

Created → Open → Answered → Closed
                    ↓
              Reopened → Open
1

Query Created

Study team raises a query on a data field.
2

Open

Query is open and awaiting site response.
3

Site Responds

Site team provides response or makes corrections.
4

Review Response

Study team reviews the response.
5

Close or Reopen

If satisfactory, close the query. Otherwise, reopen.

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Query Creation

When a query is created:
  • Associated with a specific field and record
  • Query text describes the issue
  • Record status changes to “Queries in Progress”
  • Site team is notified

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Open State

While open:
  • Appears in site team’s query queue
  • Blocks record verification
  • May indicate if value change is expected

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Value Change Expected

When raising a query, indicate whether a data value change is expected:
SettingMeaning
YesSite should change the data value
NoSite should clarify without changing

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Site Response

Site team responds to queries by:
  1. Reading the query text
  2. Investigating the issue
  3. Updating data if needed
  4. Providing a response explanation

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Response Content

Responses should include:
  • Explanation or clarification
  • Reason for any data change
  • Reference to source documents if applicable

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Study Team Review

After site responds:
1

Review Response

Examine the site’s response and any data changes.
2

Assess Adequacy

Determine if the response resolves the query.
3

Close or Reopen

Close if resolved; reopen if further clarification needed.

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Closing Queries

When closing a query:
  • Record status may return to “Completed (Site)”
  • Closure is recorded in audit trail
  • No further responses accepted

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Reopening Queries

If the response is insufficient:
  • Add follow-up comment explaining what’s still needed
  • Query returns to Open state
  • Site receives notification
Avoid excessive reopens. Write clear initial queries and clear follow-up requests.

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Multiple Queries

A record can have multiple queries:
  • Each query tracks independently
  • Record stays in “Queries in Progress” until all closed
  • Queries can be on different fields

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Query History

Full query history is preserved:
  • Original query text
  • All responses and comments
  • Status changes with timestamps
  • User actions
Click on a query to see its complete history, including all messages and status changes.

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Impact on Record Workflow

Queries affect the record workflow:
ScenarioRecord Status
Query openedQueries in Progress
All queries closedCompleted (Site)
Ready for sign-offVerified (Study Team)

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Notifications

Query events trigger notifications:
EventNotified
Query createdSite team
Response providedStudy team
Query reopenedSite team
Query closedSite team

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Best Practices

Address queries quickly to maintain data quality timelines.
Provide thorough responses to avoid reopening.
Cite source documents when clarifying data.
Regularly review open query counts by site.

Creating Queries

How to raise queries.

Responding to Queries

How to respond to queries.