Which statement correctly describes sponsor auditing procedures?

Which statement correctly describes sponsor auditing procedures?

• A. Audits must be conducted by regulatory authorities only, not by sponsor personnel.
• B. Audits may be conducted without documented procedures if the auditor is trusted.
• C. The sponsor should ensure that auditing is conducted in accordance with written procedures on what to audit, how to audit, frequency of audits, and the form and content of audit reports.
• D. Audit reports are optional and need not be retained.

Answer: (C)

Audits are a key part of the sponsor’s quality assurance program and must be guided by written procedures. These procedures spell out what to audit, how to audit, how often audits should occur, and the form and content of audit reports. Having this documentation ensures audits are performed consistently and objectively across sites and vendors, and it creates traceable records that support corrective actions and regulatory reviews. Regulatory authorities may conduct audits, but sponsor-led audits are not restricted to authorities alone. Audits should still follow the sponsor’s documented procedures. Written procedures are also essential because audit reports are not optional; they are created, finalized, and retained as part of the trial’s quality system to document findings and CAPAs.

Audits are a key part of the sponsor’s quality assurance program and must be guided by written procedures. These procedures spell out what to audit, how to audit, how often audits should occur, and the form and content of audit reports. Having this documentation ensures audits are performed consistently and objectively across sites and vendors, and it creates traceable records that support corrective actions and regulatory reviews.

Regulatory authorities may conduct audits, but sponsor-led audits are not restricted to authorities alone. Audits should still follow the sponsor’s documented procedures. Written procedures are also essential because audit reports are not optional; they are created, finalized, and retained as part of the trial’s quality system to document findings and CAPAs.