Glossary

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.

Established procedure to be followed in carrying out a given operation or in a given situation.

A subject describes an individual who participates in a clinical investigation.