How should the independence of the audit function be preserved?

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Maintaining independence means the audit function operates without influence from those conducting or funding the trial, ensuring findings are objective and credible. Regulators should not routinely request audit reports; they may seek access on a case-by-case basis. If audit results are shared routinely, auditors can feel pressure to shape findings or disclosures, and sensitive information could be exposed beyond what is necessary for oversight. Allowing access on a case-by-case basis gives regulators what they need during inspections while preserving the audit’s impartiality and confidentiality. Any access should follow established procedures that protect confidential data and limit disclosure to what is relevant for the regulatory review. In practice, auditors should report to an oversight body independent of the day-to-day trial activities, so their work remains free from operational influence. This approach keeps the audit function trustworthy and preserves its ability to detect and report issues impartially, which is why it is the best way to maintain independence.