How does monitoring differ from auditing in a clinical trial?

Short answer

Monitoring is ongoing quality control that checks the trial is being run as planned while it happens. An audit is an independent quality assurance review of whether the processes themselves are adequate. Monitors are part of trial operations, while auditors must be independent of the trial they audit.

Why

E6(R3) calls monitoring one of the principal quality control activities. A monitor reviews consent, eligibility, safety reporting and data against source, either on site, remotely or centrally through analysis of accumulated data. The aim is to catch and fix problems in time.

Findings go into monitoring reports and follow up actions. An audit asks a different question: are the systems and procedures fit to keep the trial compliant? The sponsor appoints auditors who are independent of the trial and plans audits by risk, for example the importance of the trial to a submission and its complexity.

Because the audit function depends on candor, E6(R3) says regulators should not routinely request audit reports, only case by case, such as when serious noncompliance is suspected. A practical example: a monitor finds three late SAE reports at one site and retrains staff. An auditor finds the sponsor's SAE intake process lacks weekend cover at every site, which is a system fix.

A strong answer covers

Monitoring as quality control during conduct
Audit as independent quality assurance of processes
Auditor independence from the trial
Site, remote and centralized monitoring methods
Regulators see audit reports only case by case

Common mistakes

Using the words monitoring and audit interchangeably.
Thinking an audit replaces the need for monitoring.
Believing monitoring means 100 percent source data verification by default.

The interviewer might ask next

What kind of finding would make you recommend a for-cause audit of a site?