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“headline”: “SOP for Onsite Monitoring Visits and Source Data Verification”,
“description”: “This SOP describes procedures for conducting onsite monitoring visits and performing source data verification (SDV) in clinical trials, ensuring compliance with FDA, EMA, CDSCO, WHO, and ICH GCP standards.”,
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Published on 21/12/2025
Standard Operating Procedure for Onsite Monitoring Visits and Source Data Verification
| Department | Clinical Operations / Monitoring |
| SOP No. | CR/OPS/064/2025 |
| Supersedes | NA |
| Page No. | 1 of 32 |
| Issue Date | 26/08/2025 |
| Effective Date | 01/09/2025 |
| Review Date | 01/09/2026 |
Purpose
The purpose of this SOP is to define the standardized procedures for conducting onsite monitoring visits and performing Source Data Verification (SDV)
Scope
This SOP applies to Clinical Research Associates (CRAs), sponsors, CROs, investigators, and QA personnel involved in trial oversight. It covers preparation, conduct, and follow-up of onsite monitoring visits, as well as verification of source data against Case Report Forms (CRFs) and electronic data capture (EDC) systems.
Responsibilities
- CRA/Monitor: Conducts onsite visits, performs SDV, and documents findings in monitoring reports.
- PI: Ensures site staff facilitate monitoring activities and provides access to source documents.
- Study Coordinator: Prepares essential documents and subject records for CRA review.
- Sponsor/CRO: Defines monitoring visit frequency and ensures timely follow-up on findings.
- QA Officer: Reviews monitoring documentation and audits selected visits.
Accountability
The sponsor is accountable for ensuring monitoring visits are planned and executed. The CRA is accountable for conducting SDV and documenting deviations or discrepancies. The PI is accountable for site compliance and implementation of corrective actions.
Procedure
1. Pre-Visit Preparation
CRA reviews protocol, Investigator Site File (ISF), prior monitoring reports, and site status.
Notify PI and study coordinator at least 2 weeks prior to visit.
Prepare Monitoring Visit Checklist (Annexure-1).
2. Conduct of Onsite Visit
Meet with PI and staff to review site progress and issues.
Verify informed consent process and ensure original signed forms are filed.
Review protocol compliance including visit schedules, dosing, and procedures.
Conduct Source Data Verification (SDV): compare CRF entries with source documents (lab reports, hospital records, AE/SAE notes).
Check drug accountability and investigational product (IP) storage conditions.
Review essential documents including delegation logs, training records, and regulatory binders.
3. Documentation During Visit
Record findings in Monitoring Visit Report (Annexure-2).
Document major deviations, missing data, or inconsistencies.
Discuss preliminary findings with PI at end of visit.
4. Post-Visit Activities
Submit monitoring report within 7 working days.
File report in TMF and ISF.
Ensure CAPA plans are initiated for deviations (Annexure-3).
5. Frequency of Visits
Conduct first monitoring visit within 4 weeks of first subject enrollment.
Subsequent visits scheduled based on enrollment rate, data volume, and risk profile (every 6–8 weeks or as defined in Monitoring Plan).
6. Escalation
Immediate escalation required for critical GCP violations or safety concerns.
Document escalations in Escalation Log (Annexure-4).
7. Archiving
Archive all monitoring visit reports, SDV checklists, CAPA documentation, and escalation logs in TMF.
Abbreviations
- SOP: Standard Operating Procedure
- PI: Principal Investigator
- CRA: Clinical Research Associate
- CRO: Clinical Research Organization
- QA: Quality Assurance
- TMF: Trial Master File
- ISF: Investigator Site File
- SDV: Source Data Verification
- IP: Investigational Product
- CAPA: Corrective and Preventive Action
Documents
- Monitoring Visit Checklist (Annexure-1)
- Monitoring Visit Report (Annexure-2)
- CAPA Log (Annexure-3)
- Escalation Log (Annexure-4)
References
- ICH E6(R2) – Good Clinical Practice
- FDA – Guidance on Risk-Based Monitoring
- EMA – Monitoring Clinical Trials
- CDSCO – Monitoring Requirements
- WHO – Onsite Monitoring Recommendations
Version: 1.0
Approval Section
| Prepared By | Ravi Kumar, CRA |
| Checked By | Sunita Reddy, QA Officer |
| Approved By | Dr. Anil Sharma, Principal Investigator |
Annexures
Annexure-1: Monitoring Visit Checklist
| Item | Status | Remarks |
|---|---|---|
| Informed Consent Verification | Complete | All subjects signed |
| Drug Accountability | Pending | IP return not documented |
Annexure-2: Monitoring Visit Report
| Date | Site | Findings | Deviation | Corrective Action |
|---|---|---|---|---|
| 15/09/2025 | Site 001 | CRF delays | 2 | Coordinator retrained |
| 17/09/2025 | Site 002 | Consent form missing page | 1 | Corrected by PI |
Annexure-3: CAPA Log
| Date | Issue | CAPA | Responsible | Status |
|---|---|---|---|---|
| 18/09/2025 | Drug accountability missing | Training + reconciliation | PI | Open |
| 19/09/2025 | Late SAE entry | Immediate reporting SOP reinforced | CRA | Closed |
Annexure-4: Escalation Log
| Date | Issue | Escalated To | Resolution | Closed By |
|---|---|---|---|---|
| 20/09/2025 | Repeated protocol deviations | Sponsor | CAPA implemented | QA Officer |
| 21/09/2025 | Incomplete consent forms | Clinical Ops Manager | Site retrained | Sponsor |
Revision History
| Revision Date | Revision No. | Revision Details | Reason for Revision | Approved By |
|---|---|---|---|---|
| 26/08/2025 | 00 | Initial version | New SOP creation | Head, Clinical Operations |
For more SOPs visit: Pharma SOP