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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:

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Lifecycle Flow

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:

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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:

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Finding Participants by Query Activity

The participant list includes a Query Status filter so you can jump straight to participants that need attention. Three activity states are tracked: Site teams can use Queries Responded to separate participants where the site still owes a response from those already handed back to the study team. Participant rows display a visual indicator when responses are pending, making it quick to spot participants ready for the next review cycle. Counts are denormalised on the participant record, so filtering stays fast on large studies.

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Notifications

Query events trigger notifications:

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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.