Data Quality Overview
Query Lifecycle
Understand the query workflow from creation to resolution.
Creating Queries
How to raise data queries.
Responding to Queries
How site teams respond to queries.
Data Quality Workflow
The data quality process ensures accuracy:1
Site Submits Data
Site completes and submits questionnaire responses.
2
Study Team Reviews
Data reviewers examine submitted data.
3
Queries Raised
Discrepancies or questions generate queries.
4
Site Responds
Site team addresses queries.
5
Verification
Study team verifies resolved data.
6
Sign-off
Authorized signer approves final record.
Query Types
Manual Queries
Raised by the study team:- Data clarification requests
- Correction requests
- Missing data inquiries
- Protocol deviation documentation
Field Change Queries
Auto-generated when field values change:Record Status with Queries
Queries affect record status:Roles in Data Quality
Query Metrics
Track data quality through metrics:Data Verification
After queries are resolved:1
Review Resolution
Examine the query response and any data changes.
2
Verify Data
Confirm data accuracy.
3
Mark Verified
Update record status to Verified (Study Team).
Verification indicates the study team has reviewed and accepted the data. It does not imply clinical judgment.
Best Practices
Clear Query Text
Clear Query Text
Write queries that clearly explain what information is needed.
Timely Review
Timely Review
Review submitted data promptly to identify issues early.
Consistent Standards
Consistent Standards
Apply consistent review criteria across all sites.
Track Patterns
Track Patterns
Monitor query patterns to identify training needs.