Standard Operating Procedure for Clinical Phase Audit Preparation in BA/BE Studies
| Department | BA-BE Studies |
|---|---|
| SOP No. | SOP/BA-BE/100/2025 |
| Supersedes | SOP/BA-BE/100/2022 |
| Page No. | Page 1 of 10 |
| Issue Date | 17/04/2025 |
| Effective Date | 20/04/2025 |
| Review Date | 17/04/2026 |
1. Purpose
To define the process for preparing the clinical site and documentation for audits conducted during or after the clinical phase of Bioavailability/Bioequivalence (BA/BE) studies, including internal QA audits, sponsor audits, and regulatory inspections.
2. Scope
This SOP applies to all clinical trial staff, including investigators, QA personnel, CRCs, and data managers involved in BA/BE studies at the research facility.
3. Responsibilities
- QA Officer: Leads the audit preparation process, schedules mock audits, and ensures readiness of documentation and facility.
- CRC: Assists with documentation collation, subject files, and query resolution.
- PI: Ensures team cooperation, participates in audit interviews, and oversees resolution of audit findings.
- Data Management Team: Ensures CRFs, eCRFs, and data listings are complete and up to date.
4. Accountability
The QA Head is accountable for audit readiness and ensuring that all clinical activities and records meet ICH GCP, Schedule Y, and applicable sponsor-specific guidelines.
5. Procedure
5.1 Audit Notification and Planning
- On receipt of audit notification (or internal scheduling), initiate audit readiness activities immediately.
- Prepare audit schedule and assign area-wise coordinators for documentation and site readiness.
5.2 Documentation Review
- Ensure availability and accessibility of the following documents:
- Signed Informed Consent Forms (ICFs)
- Approved Protocols and Amendments
- Ethics Committee correspondence
- Volunteer screening and enrollment logs
- Dosing and sample collection records
- Adverse Event logs and management reports
- Monitoring reports and query logs
- Verify CRF-to-source data consistency and resolve all outstanding data queries.
5.3 Facility Preparation
- Ensure restricted access areas are clearly marked and clean.
- Prepare audit room with:
- Printer, copier, access to study folders (paper/electronic)
- Seating arrangements for auditor and host
- Ensure IP storage, archival, sample storage areas are audit-ready.
5.4 Team Briefing
- Conduct pre-audit briefing with all study staff:
- Explain audit process
- Assign subject matter experts (SMEs)
- Discuss commonly asked questions and data flow
5.5 Conducting the Audit
- Host to welcome auditor, provide site tour, and introduce study team.
- Provide requested documents promptly and track all auditor queries in Annexure-1: Audit Query Tracker.
- Take daily feedback from auditors and prepare summary of observations.
5.6 Post-Audit Activities
- Compile draft response for all observations using Annexure-2: Audit Observation Response Form.
- Implement CAPA where applicable and update Annexure-3: CAPA Tracking Log.
- Share final responses with auditor/sponsor as per defined timeline.
6. Abbreviations
- BA: Bioavailability
- BE: Bioequivalence
- QA: Quality Assurance
- PI: Principal Investigator
- CRC: Clinical Research Coordinator
- CRF: Case Report Form
- CAPA: Corrective and Preventive Action
7. Documents
- Audit Query Tracker – Annexure-1
- Audit Observation Response Form – Annexure-2
- CAPA Tracking Log – Annexure-3
8. References
- ICH E6(R2) – Good Clinical Practice
- Schedule Y – Drugs and Cosmetics Rules
- Sponsor Audit Requirements
9. SOP Version
Version: 2.0
10. Approval Section
| Prepared By | Checked By | Approved By | |
|---|---|---|---|
| Signature | |||
| Date | |||
| Name | |||
| Designation | |||
| Department |
11. Annexures
Annexure-1: Audit Query Tracker
| Date | Query Description | Document Referenced | Status | Resolved By |
|---|---|---|---|---|
| 17/04/2025 | Missing consent signature | ICF-VOL-100 | Resolved | Sunita Reddy |
Annexure-2: Audit Observation Response Form
| Observation | Root Cause | Corrective Action | Preventive Action | Owner |
|---|---|---|---|---|
| Incomplete AE Log | Late entry | Entry updated | Real-time log review | CRC |
Annexure-3: CAPA Tracking Log
| CAPA No. | Description | Implemented On | Verified By |
|---|---|---|---|
| CAPA-100 | Retraining on AE logging | 18/04/2025 | QA Officer |
Revision History:
| Revision Date | Revision No. | Details | Reason | Approved By |
|---|---|---|---|---|
| 12/01/2022 | 1.0 | Initial SOP | Process Setup | QA Head |
| 17/04/2025 | 2.0 | Annexures and audit checklists added | GCP Inspection Readiness | QA Head |