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“headline”: “SOP for Data Query Management and Resolution in Clinical Trials”,
“description”: “This SOP defines standardized procedures for data query management and resolution in clinical trials, ensuring timely clarification of discrepancies, compliance with ICH GCP, and adherence to FDA, EMA, CDSCO, and WHO guidelines.”,
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Published on 21/12/2025
Standard Operating Procedure for Data Query Management and Resolution
| Department | Clinical Research |
| SOP No. | CR/DATA/052/2025 |
| Supersedes | NA |
| Page No. | 1 of 22 |
| Issue Date | 26/08/2025 |
| Effective Date | 01/09/2025 |
| Review Date | 01/09/2026 |
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
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
- Data Query Log (Annexure-1)
- Query Resolution Form (Annexure-2)
- 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
| Prepared By | Rajesh Kumar, Clinical Data Manager |
| Checked By | Sunita Reddy, QA Officer |
| Approved By | Dr. Anil Sharma, Principal Investigator |
Annexures
Annexure-1: Data Query Log
| Date | Subject ID | CRF Page | Query Description | Resolution | Resolved By |
|---|---|---|---|---|---|
| 12/09/2025 | CT2025-SITE01-161 | Page 18 | Missing ECG data | Updated | Study Coordinator |
Annexure-2: Query Resolution Form
| Date | Query ID | Query Description | Response Provided | Reviewed By |
|---|---|---|---|---|
| 13/09/2025 | Q-112 | Discrepancy in blood pressure values | Corrected to 120/80 mmHg | PI |
Annexure-3: CRF Correction Log
| Date | CRF Page | Correction Made | Reason | Initials |
|---|---|---|---|---|
| 14/09/2025 | Page 20 | Updated lab value entry | Data transcription error | RK |
Revision History
| Revision Date | Revision No. | Revision Details | Reason for Revision | Approved By |
|---|---|---|---|---|
| 26/08/2025 | 00 | Initial version | New SOP creation | Head, Clinical Research |
For more SOPs visit: Pharma SOP