Glossar

An adverse device effects describes an adverse event related to the use of an investigational medical devic. This includes adverse events resulting from insufficient or inadequate instructions for use, deployment, implantation, installation, or operation, or any malfunction of the investigational medical device. This includes any event resulting from use error or from intentional misuse of the investigational medical device.

An Adverse event (AE) means any untoward medical occurrence, unintended disease or injury or any untoward clinical signs, including an abnormal laboratory finding, in subjects, users or other persons, in the context of a clinical investigation, whether or not related to the investigational device.
For more safety-related terms see also serious adverse event, adverse device effect, serious adverse device effect, device deficiency and incident.

An amendment is a written description of a change(s) to or formal clarification of a protocol.

An anticipated SADE (ASADE) is an effect which by its nature, incidence, severity or outcome has been previously identified in the risk analysis report.

An approval is the affirmative decision of the ethics committee that the clinical trial has been reviewed and may be conducted at the institution site.

An audit is an systematic independent examination of activities and documents related to clinical investigation to determine whether these activities were conducted, and the data recorded, analysed and accurately reported, according to the CIP, standard operating procedures, this International Standard and applicable regulatory requirements.

A declaration of confirmation by the auditor that an audit has taken place.