1. Purpose

To describe the internal audit programme and the site's state of continuous readiness for sponsor audits and regulatory inspections, including FDA Bioresearch Monitoring (BIMO) inspections.

2. Scope

Applies to scheduled internal audits, for-cause audits, sponsor and contract research organisation audits, and inspections by the FDA or other health authorities.

3. Responsibilities

• Quality Assurance Director: Owns the annual audit schedule, leads inspection hosting, and is the single point of contact for the inspector.
• Principal Investigator: Remains available during inspections, answers questions on medical and protocol decisions, and signs off responses.
• Department Managers: Keep records audit-ready at all times and produce requested documents within the agreed interval.
• All Personnel: Answer only questions within their own role and training, truthfully and without speculation.

4. Definitions

BIMO

The FDA Bioresearch Monitoring programme, under which clinical investigator sites are inspected.

Form FDA 483

A list of inspectional observations issued at the close of an FDA inspection.

For-cause audit

An unscheduled audit triggered by a specific signal such as a serious deviation or data anomaly.

Audit trail

Secure, computer-generated, time-stamped records of creation, modification and deletion of electronic records.

5. Procedure

1. Publish an annual risk-based internal audit schedule covering every department at least once per year and every active study at least once during its conduct.
2. Notify the audited area at least ten business days before a scheduled audit, with scope, dates and the document request list.
3. Conduct the audit against the applicable protocol, SOPs and regulations, reviewing a defined sample of source documents, consent forms, delegation logs, training records and investigational product records.
4. Classify each finding as Critical, Major or Minor and issue a written audit report within ten business days of the closing meeting.
5. Require a written response with corrective actions within fifteen business days; route all Critical and Major findings into the CAPA system under QA-002.
6. Maintain continuous inspection readiness: the regulatory binder is current per REG-001, training records are complete per TRN-001, and no signature or date fields are left blank.
7. Perform a documented mock inspection at least annually, including a facility walk-through, a records request exercise and staff interview practice.
8. On notification of a sponsor audit or regulatory inspection, notify the Quality Assurance Director, Principal Investigator and Chief Medical Officer immediately and reserve a dedicated room.
9. Verify the inspector's credentials and Form FDA 482 at arrival, record the inspector's name and contact details, and keep a running log of every document provided.
10. Escort the inspector at all times; never leave an inspector alone with records or unsupervised in areas containing protected health information.
11. Provide only requested documents; redact protected health information of subjects not enrolled in the study under inspection, and never alter a record after a request is made.
12. Hold a daily internal debrief during multi-day inspections to review questions asked, documents provided and issues to prepare.
13. Attend the closing meeting, record all observations verbatim, and request clarification of any observation that is not understood.
14. Submit a written response to any Form FDA 483 observation within fifteen business days of receipt, with corrective actions, owners and dates, approved by the Principal Investigator and Quality Assurance Director.
15. Retain audit and inspection records, responses and correspondence for the retention period defined in DAT-003.

6. References

• 21 CFR Part 312 — Investigational New Drug Application
• 21 CFR Part 812 — Investigational Device Exemptions
• FDA Compliance Program Guidance Manual 7348.811 (Clinical Investigators)
• ICH E6(R3) Good Clinical Practice
• QA-002 Corrective and Preventive Action (CAPA)
• REG-001 Regulatory Binder / Essential Documents Maintenance

7. Revision History

• v1.0 · Jul 22, 2019 — Initial issue.
• v2.0 · May 30, 2022 — Added mock inspection requirement and escort rules.
• v3.0 · Aug 12, 2025 — Expanded BIMO section and Form 483 response timeline.