Audit
In Oversight, quality & inspection
An audit is a systematic, independent examination of trial activities and documents to judge whether they were carried out according to the protocol, SOPs, GCP, and regulation. Audits are commissioned by the sponsor or the institution and performed by people independent of the trial team. They are internal quality assurance — not the same as a regulatory inspection.
Example
A sponsor's quality-assurance group audits three high-enrolling sites before submitting the trial for approval, to find problems while there is still time to fix them.
Common questions
- What is the difference between an audit and an inspection?
- An audit is commissioned by the sponsor or institution and carried out by independent staff or contractors as internal quality assurance. An inspection is carried out by a regulatory authority and can have legal consequences.
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