Quality Assurance Audits. The Sponsor’s (or an authorized representative’s) Quality Assurance department may conduct on-site audits of all aspects of the clinical study either during the study or after the study has been completed. The clinical study may also be subject to inspection by regulatory authorities (national or foreign) as well as the IECs/IRBs to ascertain that the study is being or has been conducted in accordance with protocol requirements, GCPs, as well as the applicable regulatory requirements.
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