compliance with GCP, protocol requirements, and regulatory standards while verifying that clinical trial processes, vendors, CROs, and investigator sites operate in alignment with contractual and ethical obligations.

Scope

This SOP applies to sponsor QA, clinical operations, and external auditors engaged in sponsor-led audits of investigator sites, CROs, vendors, laboratories, and internal sponsor functions. It covers audit preparation, execution, reporting, CAPA management, escalation, and archiving across multi-regional trials governed by FDA, EMA, CDSCO, WHO, and ICH GCP requirements.

Responsibilities

• Sponsor QA: Plans, schedules, and executes audits.
• Clinical Operations: Provides logistical support and ensures corrective actions are implemented.
• Auditor: Conducts audit objectively, records evidence, and prepares audit reports.
• PI/Site Staff: Provides access to trial data, documents, and processes during audit.
• Vendor/CRO: Facilitates audits of outsourced activities and ensures CAPA compliance.
• Head of QA: Reviews audit reports and approves closure of findings.

Accountability

The sponsor is accountable for ensuring that audits are planned, executed, and documented. QA is accountable for the independence of audits, while Clinical Operations ensures CAPA implementation.

Procedure

1. Audit Planning
Develop Annual Audit Plan based on risk, trial phase, site activity, and regulatory priorities.
Document plan in Audit Planning Log (Annexure-1).
Include internal functions, investigator sites, CROs, and vendors.

2. Audit Preparation
Notify auditee at least 4 weeks in advance (except for for-cause audits).
Define audit scope, objectives, methodology, and checklist (Annexure-2).
Assign trained auditors with no conflict of interest.

3. Audit Execution
Conduct opening meeting with auditee.
Review TMF, ISF, informed consent, CRFs, source data, IP accountability, training records, and safety reporting.
Observe processes, interview staff, and verify compliance with SOPs and regulations.
Record evidence in Audit Notes (Annexure-3).

4. Audit Findings
Classify findings as Critical, Major, or Minor.
Discuss preliminary findings in exit meeting.
Document findings in Audit Findings Log (Annexure-4).

5. Audit Report
Prepare draft audit report within 10 working days.
Sponsor QA reviews and finalizes within 15 working days.
File final report in TMF and share with auditee.

6. CAPA Management
Auditee submits CAPA plan within 20 working days.
QA reviews and approves CAPA.
CRA verifies CAPA implementation during follow-up visits.
Document CAPA closure in CAPA Log (Annexure-5).

7. Escalation
Escalate unresolved critical findings to senior management.
Document in Escalation Log (Annexure-6).

8. Archiving
Archive audit plans, reports, findings, CAPAs, and escalation logs in TMF.
Retain documents for 15–25 years per regional regulations.

Abbreviations

• SOP: Standard Operating Procedure
• PI: Principal Investigator
• CRA: Clinical Research Associate
• CRO: Contract Research Organization
• QA: Quality Assurance
• TMF: Trial Master File
• ISF: Investigator Site File
• CAPA: Corrective and Preventive Action

Documents

1. Audit Planning Log (Annexure-1)
2. Audit Checklist (Annexure-2)
3. Audit Notes (Annexure-3)
4. Audit Findings Log (Annexure-4)
5. CAPA Log (Annexure-5)
6. Escalation Log (Annexure-6)

References

• ICH E6(R2) – Good Clinical Practice
• FDA – Sponsor Audit Guidance
• EMA – Oversight of Clinical Trials
• CDSCO – Sponsor Audit Requirements
• WHO – Sponsor Audit Guidelines

Version: 1.0

Approval Section

Prepared By	Ravi Kumar, QA Auditor
Checked By	Sunita Reddy, QA Officer
Approved By	Dr. Anil Sharma, Head Clinical Quality

Annexures

Annexure-1: Audit Planning Log

Date	Audit Type	Entity	Planned By	Status
01/09/2025	Site Audit	Site 001	QA Officer	Planned
05/09/2025	Vendor Audit	ABC Labs	QA Auditor	Scheduled

Annexure-2: Audit Checklist

Section	Item	Status
Informed Consent	Signed and dated forms	✔️
Drug Accountability	Complete reconciliation	Pending

Annexure-3: Audit Notes

Date	Observation	Evidence	Auditor
10/09/2025	Late SAE reporting	SAE form dated 3 days late	QA Auditor
12/09/2025	IP storage temp excursion	Temp logs missing	QA Auditor

Annexure-4: Audit Findings Log

Date	Finding	Category	Auditee	Status
15/09/2025	Consent form missing page	Major	Site 001	Open
16/09/2025	Incomplete monitoring report	Minor	XYZ CRO	Closed

Annexure-5: CAPA Log

Date	Finding	CAPA	Responsible	Status
17/09/2025	Incomplete IP accountability	Reconciliation + retraining	PI	Closed
18/09/2025	SAE reporting delay	Process updated	CRO	Open

Annexure-6: Escalation Log

Date	Issue	Escalated To	Resolution	Closed By
20/09/2025	Repeated protocol deviations	Sponsor Management	Investigation initiated	QA Officer
21/09/2025	Vendor data integrity concerns	Head QA	Audit extended	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 Quality

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