根据ICH GCP R2 5.19 Audit稽查是申办者的职责；ICH GCP R2 5.19.2 Selection and Qualification of Auditors要求，The sponsor should ensure that the auditors are qualified by training and experience to conduct audits properly. An auditor’s qualifications should be documented. 如果申办者选择将稽查的工作外包给第三方公司执行，也需根据ICH GCP R2 5.2.2的要求，The sponsor should ensure oversight of any trial-related duties and functions carried out on its behalf，对第三方公司进行合格性评估后使用。