Glossary

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.

A clinical investigation is any systematic investigation involving one or more human subjects, undertaken to assess the safety and performance of a device.

A clinical investigation plan (CIP) displays the rationale, objectives, design, methodology, monitoring, statistical considerations, organization and conduct of a clinical investigation.

A clinical investigation report (CIR) describes the design, execution, statistical analysis and results of a clinical investigation.

The clinical investigator is described as an individual responsible for the conduct of a clinical investigation at a clinical investigation site.

Clinical performance describes the ability of a medical device to achieve its intended purpose as claimed by the manufacturer.

Clinical safety is described by the absence of unacceptable clinical risks, when using the device according to the manufacturer’s Instructions for Use.

The comparator can be a medical device, therapy (e.g. active control), placebo or no treatment, used in the reference group in a clinical investigation.

A competent authority is any person or organization that has the legally delegated or invested authority, capacity, or power to perform a designated function.
Clinical investigations for medical devices and performance evaluations of in vitro diagnostic agents in Germany must be approved by the competent authority and approvingly evaluated by an Ethics Committee before they may commence.

Competent authorities in Germany are BfArM and PEI.

Compliance describes the adherence to all the trial-related requirements, Good Clinical Practice requirements, and the applicable regulatory requirements.