Glossary

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.

Procedure in which one or more parties to the clinical investigation are kept unaware of the treatment assignment(s).
Single blinding usually refers to the subject(s) being unaware of the treatment assignment(s).
Double blinding usually refers to the subject(s), investigator(s), monitor and, in some cases, centralized assessors being unaware of the treatment assignment(s).

The Federal Institute for Drugs and Medical Devices (in German: Bundesinstitut für Arzneimittel und Medizinprodukte - BfArM) is as an competent authority responsible for clinical investigations of medical devices and for performance evaluations of in vitro diagnostic agents, with the exception of those for which the Paul-Ehrlich-Institute is responsible.

The case report form is a document designed to record all information to be reported to the sponsor on each subject as required by the clinical investigation plan.

A copy of the original record that has been verified to have the same information including data that describe the context, content, and structure, as the original. Verfication can be made by a dated signature or by generation through a validated process. The type of media used for the copy is irrespective.

A clinical benefit describes the positive impact of a device on the health of an individual. It can be expressed in terms of a meaningful measurable, patient-relevant clinical outcome, including outcome related to diagnosis or a positive impact on patient management or public health.

Clinical data means information concerning safety on performance that is generated from the use of a device. Clinical data can be generated in clinical investigations or other studies which were conducted and / or reported in scientific literature or from post market surveillance like the post market clinical follow-up.

A clinical evaluation means a systematic and planned process to continuously generate, collect, analyse and assess the clinical data pertaining to a device in order to verify the safety and performance, including clinical benefits, of the device when used as intended by the manufacturer.

To allow a qualified assessment of whether the device is safe and achieves the intended clinical benefit(s) claimed by the manufacturer, clinical evidence provided by clinical data and clinical evaluation results pertaining to a device of a sufficient amount and quality.