Standard Operating Procedure for Source Data Verification for Dossier Preparation
| Department | Regulatory Affairs |
| SOP No. | RA/2026/711 |
| Supersedes | NA |
| Page No. | 1 of X |
| Issue Date | 13/04/2026 |
| Effective Date | 13/04/2026 |
| Review Date | 13/04/2028 |
Purpose
This Standard Operating Procedure (SOP) establishes the systematic approach for conducting Source Data Verification (SDV) during dossier preparation activities within the Regulatory Affairs department. The objective is to ensure accuracy, completeness, and integrity of source data that supports submissions, guaranteeing compliance with regulatory requirements and enabling reliable decision-making throughout the dossier compilation and submission process.
Scope
This SOP applies to all personnel involved in the verification and validation of source data related to dossier preparation activities for any pharmaceutical, biotechnology, or medical device products. It covers all types of source documents, data formats, and systems that feed into regulatory submissions, including but not limited to clinical study reports, manufacturing batch records, analytical data, and validation documentation. This SOP excludes activities related to dossier submission finalization and regulatory agency communications post-submission.
Responsibilities
- Regulatory Affairs Associates: Execute source data verification as per the defined checklist and report discrepancies.
- Regulatory Affairs Supervisors: Review and validate completed SDV records and manage deviation reports.
- Quality Assurance (QA): Oversee compliance with this SOP, conduct audits on SDV activities, and approve corrective actions for any non-conformities.
- Document Control: Ensure controlled distribution, archiving, and retrieval of verified documents.
- Functional Area Heads: Facilitate availability of source data and ensure staff compliance with SDV requirements.
Accountability
The Head of Regulatory Affairs is accountable for the implementation, adherence, periodic review, and continuous improvement of this SOP. They are responsible for escalation of any compliance issues identified during SDV, ensuring training effectiveness, and maintaining audit readiness related to dossier source data management.
Procedure
The Source Data Verification process for dossier preparation shall be conducted using the following comprehensive steps to ensure compliance and data integrity:
1. Preparation and Prerequisites:
Obtain access to all relevant source documents and electronic data systems identified for the dossier section under preparation. Confirm the latest versions of all applicable working instructions and templates. Ensure training on this SOP and related documentation control procedures has been completed by all involved personnel.
2. Verification Planning:
Define the scope of SDV for the dossier section, specifying which data sets and documents will be verified. Prepare a Source Data Verification Checklist tailored to the product and dossier requirements. Schedule the SDV in coordination with document preparers to minimize workflow disruption.
3. Execution of SDV:
Compare all data entered into dossier sections against the original source documents, including but not limited to raw laboratory data, validated analytical reports, manufacturing batch records, and clinical study databases. Verify correct transcription, data consistency, and compliance with regulatory guidelines. Identify discrepancies, annotate them clearly, and document observations using standardized deviation or query forms.
4. In-Process Controls and Checks:
Maintain strict adherence to Good Documentation Practices (GDP) during verification. Confirm document authenticity, legibility, and completeness. Use electronic tools where applicable to enhance traceability and audit trails.
5. Review and Approval:
Submit completed SDV checklists and discrepancy reports to the Regulatory Affairs Supervisor for review and resolution. Ensure that clarifications or corrections are documented and incorporated as needed. Obtain approvals from authorized personnel before proceeding further with dossier compilation.
6. Documentation and Record Retention:
Store all verified source documents, checklists, deviation reports, and related communications in the designated controlled systems or physical archives. Ensure records are retrievable for regulatory inspections and internal audits for the retention period defined by applicable regulations.
7. Handling Deviations:
For any identified deviations or non-conformances, initiate an investigation in accordance with the investigation SOP. Implement corrective and preventive actions and document closure of the deviation in the SDV records.
8. Closure:
Confirm completion of SDV for the targeted dossier sections through final checklist sign-off. Communicate completion status to dossier preparers and Quality teams to support timely submission.
This procedure shall be reviewed annually or as needed following regulatory updates to ensure ongoing compliance and effectiveness.
Abbreviations
- SDV – Source Data Verification
- GMP – Good Manufacturing Practices
- GDP – Good Documentation Practices
- QA – Quality Assurance
- RA – Regulatory Affairs
- SOP – Standard Operating Procedure
Documents
The following documents are essential and specific to the Source Data Verification process during dossier preparation:
- Source Data Verification Checklist (Annexure-1)
- SDV Deviation/Query Report Form (Annexure-2)
- SDV Completion and Approval Log (Annexure-3)
References
- ICH Q7 Good Manufacturing Practice Guide
- ICH E6(R3) Good Clinical Practice
- 21 CFR Part 11 – Electronic Records; Electronic Signatures
- EMA Guidelines on Quality Documentation
- Internal Document Control and Quality Management Systems
Version
1.0
Approval
| Prepared By | |
| Checked By | |
| Approved By |
Annexures
Annexure-1: Source Data Verification Checklist
Purpose: To provide a structured checklist for systematic verification of source data against dossier entries ensuring completeness and compliance.
| Section/Module | Data Source Type | Verified By | Date | Status (Yes/No) | Remarks |
|---|---|---|---|---|---|
| Clinical Study Report | Raw Data Listings | 10/04/2026 | Yes | Complete and consistent | |
| Manufacturing Data | Batch Records | 11/04/2026 | Yes | No discrepancies found | |
| Analytical Reports | Validated Test Reports | 12/04/2026 | Yes | Data verified against raw |
Annexure-2: SDV Deviation/Query Report Form
Purpose: To document any deviations, discrepancies, or queries raised during the source data verification process and track their resolution.
| Report No. | SDV-2026-00711 |
| Date Raised | 10/04/2026 |
| Section/Module | Clinical Study Data |
| Description of Deviation/Query | Discrepancy between lab raw data and summarized results in report. |
| Root Cause Analysis | Data entry error during transcription. |
| Corrective Action | Correction made in dossier; implemented double-check procedure for future entries. |
| Status | Closed |
| Verified By | |
| Date | 12/04/2026 |
Annexure-3: SDV Completion and Approval Log
Purpose: To record the final completion status of source data verification activities and obtain necessary approvals documenting compliance and readiness for dossier submission.
| Dossier Section | SDV Verified By | Date Verified | Reviewed By | Date Reviewed | Approval Status |
|---|---|---|---|---|---|
| Module 2 – Quality | 12/04/2026 | 13/04/2026 | Approved | ||
| Module 5 – Clinical | 13/04/2026 | 13/04/2026 | Approved |
Revision History
| Revision Date | Revision No. | Revision Details | Reason for Revision | Approved By |
| 13/04/2026 | 1.0 | Initial issue | New SOP creation |