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Data queries are raised by the study team to request clarification or correction of submitted data. This guide covers how to create effective queries.

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Who Can Create Queries

RoleCan Create Queries
Data Reviewer (Study Team)Yes
Study AdministratorYes
CI/D-CIYes
Site RolesNo

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Creating a Query

1

Navigate to Record

Open the participant record and questionnaire response.
2

Select Field

Identify the field requiring clarification.
3

Open Query Dialog

Click the query icon or “Raise Query” option for the field.
4

Enter Query Details

Provide query text and options.
5

Submit

Submit the query. Site team is notified.

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Query Details

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Query Text

Write clear, specific query text:
  • Describe the issue or discrepancy
  • Specify what information is needed
  • Reference relevant guidelines if applicable
Good example: “The recorded blood pressure (280/160 mmHg) appears unusually high. Please verify this value against source documents.”Avoid: “Check BP”

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Value Change Expected

Indicate whether you expect the data to change:
OptionWhen to Use
YesData appears incorrect; expect correction
NoNeed clarification; data may be correct
This helps site teams understand what’s needed.

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Query Reasons

Categorize queries by reason:
ReasonDescription
ClarificationNeed more information
Out of RangeValue outside expected range
Missing DataRequired data not provided
InconsistencyData conflicts with other entries
Protocol DeviationPotential protocol deviation
Transcription ErrorLikely data entry mistake

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Field-Level vs. Record-Level

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Field-Level Queries

Most common type:
  • Associated with a specific field
  • Displayed inline with the field
  • Clear context for site response

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Record-Level Queries

For general issues:
  • Not tied to specific field
  • Address overall record concerns
  • May span multiple fields

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Query Tips

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Be Specific

Specific (Good):
  • “Date of Visit (15-Jan-2024) is before enrollment date (20-Jan-2024). Please clarify.”
  • “Weight value (750 kg) exceeds physiological range. Please verify.”
Vague (Avoid):
  • “Check date”
  • “Weight looks wrong”

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Provide Context

Include relevant context:
  • What triggered the query
  • What the expected value might be
  • Reference to related data if applicable

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One Issue Per Query

Address one issue per query:
  • Easier for site to respond
  • Clearer audit trail
  • Independent resolution

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Bulk Query Operations

For multiple related issues:
1

Review Records

Identify all records with similar issues.
2

Create Individual Queries

Create a query on each affected record.
3

Track as Group

Note the related queries for follow-up.

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Query Templates

If available, use query templates:
  • Standardized text for common issues
  • Consistent query quality
  • Faster query creation

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Effect of Query Creation

When a query is created:
ChangeResult
Record StatusChanges to “Queries in Progress”
Site NotificationSite team alerted
Query CountIncremented for tracking
Audit TrailQuery creation logged

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Best Practices

Ensure you’ve examined all relevant data before raising a query.
Write queries professionally and neutrally.
Accurately indicate if value change is expected.
Check for existing queries before creating new ones.

Query Lifecycle

Full query workflow.

Responding to Queries

How sites respond.