Standard Operating Procedure for Maintaining Source Data Verification Logs in BA/BE Studies
| Department | BA-BE Studies |
|---|---|
| SOP No. | SOP/BA-BE/124/2025 |
| Supersedes | SOP/BA-BE/124/2022 |
| Page No. | Page 1 of 9 |
| Issue Date | 17/04/2025 |
| Effective Date | 20/04/2025 |
| Review Date | 17/04/2026 |
1. Purpose
To establish a consistent and regulatory-compliant procedure for maintaining Source Data Verification (SDV) logs in BA/BE studies to confirm data accuracy between source documents and case report forms (CRFs).
2. Scope
This SOP applies to all clinical research associates (CRAs), quality assurance staff, monitors, and site personnel responsible for verifying and documenting source data against study CRFs or electronic CRFs
during BA/BE studies.
3. Responsibilities
- Clinical Research Associate (CRA): Performs SDV activities and records entries in the SDV log.
- Principal Investigator (PI): Ensures availability of accurate and legible source documentation.
- Study Coordinator: Assists in making all original source documents available for verification.
- Quality Assurance: Reviews SDV logs for completeness and identifies potential discrepancies.
4. Accountability
The Clinical QA Manager is accountable for ensuring SDV is systematically documented and reviewed in compliance with GCP and protocol requirements.
5. Procedure
5.1 Preparation for SDV
- Prior to the SDV visit, the CRA shall:
- Obtain subject enrollment list and CRF pages from site.
- Request availability of original source documents.
- Ensure all documents are anonymized and complete before initiating SDV.
5.2 SDV Log Maintenance
- Use Annexure-1: Source Data Verification Log to document each verification entry.
- Log shall capture:
- Subject ID
- Visit or timepoint
- Data fields verified (e.g., vitals, lab reports, consent)
- Verification status (Match/Discrepant)
- Date and initials of verifier
- Discrepancies identified shall be flagged in the log and followed up with a data query (DQ) form.
5.3 Frequency and Coverage
- SDV shall be conducted:
- During site initiation (partial SDV for training)
- During interim monitoring (targeted or 100% SDV)
- During closeout visit (final SDV)
- CRAs shall aim to complete SDV for at least 25–100% of subjects depending on the monitoring plan.
5.4 SDV for Electronic Data
- For EDC (Electronic Data Capture) systems:
- Login and access rights must be documented.
- Print audit trails if applicable.
- Electronic records must comply with 21 CFR Part 11 or equivalent regulatory standard.
5.5 Post-SDV Follow-up
- All discrepancy resolutions must be documented and tracked in Annexure-2: SDV Discrepancy Resolution Log.
- SDV status for each subject shall be updated in Annexure-3: Subject SDV Status Tracker.
- Submit SDV summary report to sponsor/QA within 5 working days of visit.
6. Abbreviations
- BA: Bioavailability
- BE: Bioequivalence
- SDV: Source Data Verification
- CRA: Clinical Research Associate
- PI: Principal Investigator
- CRF: Case Report Form
- DQ: Data Query
7. Documents
- Source Data Verification Log – Annexure-1
- SDV Discrepancy Resolution Log – Annexure-2
- Subject SDV Status Tracker – Annexure-3
8. References
- ICH E6(R2) – Good Clinical Practice
- US FDA Guidance on Source Data
- 21 CFR Part 11 – Electronic Records
9. SOP Version
Version: 2.0
10. Approval Section
| Prepared By | Checked By | Approved By | |
|---|---|---|---|
| Signature | |||
| Date | |||
| Name | |||
| Designation | |||
| Department |
11. Annexures
Annexure-1: Source Data Verification Log
| Subject ID | Visit | Field Verified | Status | Date | Verified By |
|---|---|---|---|---|---|
| V012 | Day 0 | Vitals, Consent | Match | 15/04/2025 | Rajesh Kumar |
Annexure-2: SDV Discrepancy Resolution Log
| Subject ID | Discrepancy | Resolution | Date Closed | Resolved By |
|---|---|---|---|---|
| V014 | Mismatch in BP reading | Corrected CRF | 16/04/2025 | Sunita Reddy |
Annexure-3: Subject SDV Status Tracker
| Subject ID | Screened | Dosed | SDV Completed | Remarks |
|---|---|---|---|---|
| V010 | Yes | Yes | Yes | None |
Revision History:
| Revision Date | Revision No. | Details | Reason | Approved By |
|---|---|---|---|---|
| 10/01/2022 | 1.0 | Initial Release | New SOP | QA Head |
| 17/04/2025 | 2.0 | Included EDC-based SDV and audit trail reference | ICH E6(R2) update | QA Head |