Audit

In ISO 14155 an audit is done by people independent of the investigation and checks conduct and data against the CIP, procedures and regulations. It is separate from monitoring, which the sponsor does continuously during the study.

systematic examination of activities and documents related to a clinical investigation (3.8) performed by (an) independent (3.26) person(s), to determine whether these activities were conducted, and the data recorded, analysed and accurately reported, according to the CIP, standard operating procedures, this document, and applicable regulatory requirements

ISO 14155:2020, clause 3.3

systematic, independent and documented process for obtaining objective evidence (3.8) and evaluating it objectively to determine the extent to which the audit criteria (3.7) are fulfilled Note 1 to entry: Internal audits, sometimes called first party audits, are conducted by, or on behalf of, the organization itself. Note 2 to entry: External audits include those generally called second and third party audits. Second party audits are conducted by parties having an interest in the organization, such as customers, or by other individuals on their behalf. Third party audits are conducted by independent auditing organizations, such as those providing certification/registration of conformity or governmental agencies. [SOURCE: ISO 9000:2015, 3.13.1, modified — Notes to entry have been modified]

ISO 19011:2018, clause 3.1