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“headline”: “SOP for Non-Compliance Escalation and CAPA”,
“description”: “This SOP defines procedures for non-compliance escalation and Corrective and Preventive Action (CAPA) in clinical trials. It ensures timely detection, reporting, root cause analysis, escalation, and implementation of CAPA in compliance with FDA, EMA, CDSCO, WHO, and ICH GCP requirements.”,
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Published on 22/12/2025
Standard Operating Procedure for Non-Compliance Escalation and CAPA
| SOP No. | CR/OPS/099/2025 |
| Supersedes | NA |
| Page No. | 1 of 42 |
| Issue Date | 26/08/2025 |
| Effective Date | 01/09/2025 |
| Review Date | 01/09/2026 |
Purpose
The purpose of this SOP is to establish procedures for identifying, escalating, and addressing non-compliance in clinical trials through Corrective and Preventive Actions (CAPA).
Scope
This SOP applies to sponsors, investigators, CROs, QA, and vendors involved in clinical research. It covers detection, categorization, escalation, root cause analysis, CAPA planning, implementation, verification, and closure of non-compliance issues across all trial-related activities.
Responsibilities
- Sponsor: Defines escalation framework and ensures oversight of CAPA processes.
- Investigators: Report deviations and implement corrective actions at the site level.
- QA: Monitors non-compliance reporting, performs root cause analysis, and approves CAPA plans.
- CROs: Ensure site compliance and escalate significant deviations to the sponsor.
- Vendors: Report and document non-compliance issues in outsourced services.
Accountability
The Sponsor is accountable for ensuring non-compliance is escalated and resolved. QA is accountable for verifying CAPA implementation and maintaining inspection readiness.
Procedure
1. Detection of Non-Compliance
1.1 Identify non-compliance through monitoring visits, audits, inspections, or daily trial activities.
1.2 Document findings in Non-Compliance Log (Annexure-1).
2. Categorization
2.1 Classify non-compliance as minor, major, or critical.
2.2 Define escalation timelines based on severity (e.g., immediate for critical, 7 days for major).
3. Escalation Process
3.1 Notify site PI, Sponsor, and QA within defined timelines.
3.2 For critical issues, escalate immediately to regulatory authorities if subject safety is at risk.
3.3 Maintain Escalation Log (Annexure-2).
4. Root Cause Analysis
4.1 Perform analysis using tools like 5-Why or Fishbone Diagram.
4.2 Record analysis in Root Cause Analysis Log (Annexure-3).
5. CAPA Planning and Implementation
5.1 Define corrective actions to address immediate issues.
5.2 Define preventive actions to avoid recurrence.
5.3 Document CAPA plan in CAPA Log (Annexure-4).
6. Verification and Closure
6.1 QA verifies CAPA effectiveness within defined timelines.
6.2 Close CAPA only when compliance is restored and preventive measures are effective.
7. Documentation and Retention
7.1 Maintain all CAPA and escalation records in TMF.
7.2 Records must be available for inspection.
Abbreviations
- SOP: Standard Operating Procedure
- CAPA: Corrective and Preventive Action
- QA: Quality Assurance
- PI: Principal Investigator
- CRO: Contract Research Organization
- TMF: Trial Master File
Documents
- Non-Compliance Log (Annexure-1)
- Escalation Log (Annexure-2)
- Root Cause Analysis Log (Annexure-3)
- CAPA Log (Annexure-4)
References
- ICH E6(R2/R3) – Handling Non-Compliance
- FDA – Non-Compliance and CAPA Guidance
- EMA – Clinical Trial CAPA Management
- CDSCO – Deviation and CAPA Oversight
- WHO – Non-Compliance Management in GCP
Version: 1.0
Approval Section
| Prepared By | Ravi Kumar, QA Specialist |
| Checked By | Sunita Reddy, QA Officer |
| Approved By | Dr. Anil Sharma, Head Clinical Quality |
Annexures
Annexure-1: Non-Compliance Log
| Date | Issue | Category | Reported By | Status |
|---|---|---|---|---|
| 01/09/2025 | Missing Informed Consent Form | Major | CRA | Open |
Annexure-2: Escalation Log
| Date | Issue | Escalated To | Timeline | Action Taken |
|---|---|---|---|---|
| 02/09/2025 | Protocol Deviation | Sponsor QA | 7 days | CAPA Initiated |
Annexure-3: Root Cause Analysis Log
| Date | Issue | Root Cause | Method Used | Performed By |
|---|---|---|---|---|
| 05/09/2025 | SAE Reporting Delay | Lack of Training | 5-Why | QA Officer |
Annexure-4: CAPA Log
| Date | CAPA ID | Issue | Corrective Action | Preventive Action | Status |
|---|---|---|---|---|---|
| 10/09/2025 | CAPA-2025-03 | Incomplete CRF | Train site staff | Implement checklist | Open |
Revision History
| Revision Date | Revision No. | Revision Details | Reason for Revision | Approved By |
|---|---|---|---|---|
| 26/08/2025 | 00 | Initial version | New SOP creation | Head Clinical Quality |
For more SOPs visit: Pharma SOP