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Standard Operating Procedure for Data Query Management and Resolution

Purpose

The purpose of this SOP is to outline the standardized process for managing and resolving data queries raised during clinical trials. Data query management ensures discrepancies between Case Report Forms (CRFs) and source documents are identified, clarified, and corrected to maintain data accuracy, integrity, and regulatory compliance.

Scope

This SOP applies to investigators, study coordinators, CRAs, data managers, sponsors, and CROs engaged in clinical trial data management. It covers query generation, resolution, documentation, and reconciliation for both paper and electronic CRFs.

Responsibilities

• Principal Investigator (PI): Ensures timely and accurate responses to data queries and signs off resolutions where required.
• Study Coordinator: Provides clarifications, updates CRFs, and maintains query logs.
• Clinical Research Associate (CRA): Raises queries during monitoring visits and verifies resolution during follow-up visits.
• Data Manager: Generates queries electronically and ensures they are resolved within required timelines.
• Sponsor/CRO: Provides oversight and ensures compliance with query resolution SOPs.
• QA Officer: Audits query handling for completeness and compliance with regulations.

Accountability

The PI is accountable for ensuring timely resolution of all data queries. Sponsors are accountable for providing oversight and maintaining regulatory compliance.

Procedure

1. Query Generation
Queries may be generated by CRAs during source data verification, by data managers through electronic systems, or by auditors/inspectors.
Each query must be logged in the Data Query Log (Annexure-1).

2. Query Notification
Notify the site immediately of any queries raised.
Provide clear and concise wording to avoid misinterpretation.

3. Query Resolution
Investigators or study coordinators must respond promptly with corrections or clarifications.
All responses must be dated, signed/initialed, and documented.
For eCRFs, responses must be captured in the system with audit trail.

4. Verification
CRA verifies that query resolutions are consistent with source data.
Discrepancies unresolved must be escalated to sponsor and QA.

5. Timelines
Queries must be resolved within 5–10 working days, unless otherwise specified by the protocol.

6. Documentation
Maintain Data Query Log (Annexure-1).
File query forms and correspondence in ISF and TMF.

7. Archiving
Archive all query-related documentation for a minimum of 15 years or per regional requirements.

Abbreviations

• SOP: Standard Operating Procedure
• PI: Principal Investigator
• CRA: Clinical Research Associate
• CRO: Clinical Research Organization
• QA: Quality Assurance
• CRF: Case Report Form
• ISF: Investigator Site File
• TMF: Trial Master File

Documents

1. Data Query Log (Annexure-1)
2. Query Resolution Form (Annexure-2)
3. CRF Correction Log (Annexure-3)

References

• ICH E6(R2) – Good Clinical Practice
• US FDA – Clinical Data Management Guidance
• EMA – Data Integrity and Query Resolution Standards
• CDSCO – Clinical Trial Data Documentation Guidelines
• WHO – Clinical Research Data Management Requirements

Version: 1.0

Approval Section

Annexures

Annexure-1: Data Query Log

Annexure-2: Query Resolution Form

Annexure-3: CRF Correction Log

Revision History

For more SOPs visit: Pharma SOP