Glossary

An investigation site is an institution or site where the clinical investigation is carried out.

An investigational device is a medical device that is assessed in a clinical investigation.

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

For specifications see also clinical investigator or coordinating (clinical) investigator.

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.

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.

A medical device can be any instrument, apparatus, appliance, material or other article, whether used alone or in combination, including the software necessary for its proper application, intended by the manufacturer to be used on human beings for the purpose of

a) diagnosis, prevention, monitoring, treatment or alleviation of disease,

b) diagnosis, monitoring, treatment, alleviation or compensation for an injury or handicap,

c) investigation, replacement or modification of the anatomy or of a physiological process,

d) control of conception, and which does not achieve its principal intended action in or on the human body by pharmacological, immunological or metabolic means, but which may be assisted in its function by such means.

A patient describes an individual who participates in a clinical investigation, either as a recipient of the device under investigation or as a control.

The Paul-Ehrlich-Institute (PEI) is a competent authority and responsible for performance evaluations of high risk in vitro diagnostic agents.

A project manager is an individual or body with authority, accountability and responsibility for managing a project to achieve specific objectives.

A serious adverse events is described by any adverse event that led to any of the following:

a) death,
b) serious deterioration in the health of the subject, that resulted in any of the following:

i. life-threatening illness or injury,
ii.permanent impairment of a body structure or a body function,
iii. hospitalisation or prolongation of patient hospitalisation,
iv. medical or surgical intervention to prevent life-threatening illness or injury or permanent impairment to a body structure or a body function,
v. chronic disease,

c) foetal distress, foetal death or a congenital physical or mental impairment or birth defect.

A serious incident means any incident that directly or indirectly led, might have led or might lead to any of the following:

a) the death of a patient, user or other person,
b) the temporary or permanent serious deterioration of a patient's, user's or other person's state of health,
c) a serious public health threat

A serious public health threat describes an event which could result in imminent risk of death, serious deterioration in a person's state of health, or serious illness, that may require prompt remedial action, and that may cause significant morbidity or mortality in humans, or that is unusual or unexpected for the given place and time.

Source data contains all information in original records, certified copies of original records of clinical findings, observations, or other activities in a clinical investigation, necessary for the reconstruction and evaluation of the clinical investigation.
This includes source data initially recorded in an electronic format.

A source document is an original or certified copy of printed, optical or electronic document containing source data.
Examples for source documents are hospital records, laboratory notes, device accountability records, photographic negatives, radiographs, records kept at the investigation site, at the laboratories and at the medico-technical departments involved in the clinical investigation.

A sponsor is describes by any individual, company, institution or organization which takes responsibility for the initiation, for the management and setting up of the financing of the clinical investigation.