The glossary explains some important terms used in clinical research and clinical trials. In addition to our own knowledge and expertise, the following sources were used to define the terms:
An incident is any malfunction or deterioration in the characteristics or performance of a device made available on the market.
An inclusion criteria is a characteristics of an individual which qualify them from taking part in a clinical investigation.
See also exclusion criteria.
Informed consent means a subject's free and voluntary expression of his or her willingness to participate in a particular clinical investigation, after having been informed of all aspects of the clinical investigation that are relevant to the subject's decision to participate.
|instruction for use - IFU||
The instruction for use provides information about the medical device like the intended purpose, the proper use and any precautions to be taken. It addresses the user of the medical device and is provided by the manufacturer.
The intended purpose describes the use for which a device is intended according to the data supplied by the manufacturer on the label and in the instructions.
An investigation site is an institution or site where the clinical investigation is carried out.Synonyme - investigation centre
|investigational medical device||
An investigational device is a medical device that is assessed in a clinical investigation.
|investigator site file - ISF||
The investigator site file (ISF) contains all essential documents of the clinical trial. It must contain all documents and forms for the investigation site to conduct the clinical trial properly in accordance with the CIP, the applicable regulatory requirements and the principles and standards of GCP. Unlike the TMF, the ISF remains at the investigation site.
|investigator's brochure - IB||
The investigator's brochure (IB) shall contain the clinical and non-clinical information on the investigational device that is relevant for the investigation and available at the time of application. Any updates to the IB or other relevant information that is newly available shall be brought to the attention of the investigators in a timely manner.