Page 225 - Safety Risk Management for Medical Devices

204 Safety Risk Management for Medical Devices

26.1 TERMINOLOGY
In the following sections references are made to the following terms. It is important to
understand the language of clinical investigations and be able to distinguish the terms.
Adverse Device Effect (ADE): “Adverse event related to the use of an investigational
medical device” ([33] 3.1).
Adverse Event (AE): “Any untoward medical occurrence, unintended disease or injury,
or untoward clinical signs (including abnormal laboratory findings) in subjects, users or
other persons, whether or not related to the investigational medical device” ([33] 3.2).
Clinical Evaluation: A methodologically sound ongoing procedure to collect,
appraise and analyze clinical data pertaining to a medical device, and to evaluate
whether there is sufficient clinical evidence to confirm compliance with relevant
essential requirements for safety and performance when using the device according to
the manufacturer’s Instructions for Use [32].
Clinical Investigation: Systematic investigation in one or more human subjects,
undertaken to assess the safety or performance of a medical device ([33] 3.6).
Clinical Investigation Plan (CIP): Document that states the rationale, objectives,
design and proposed analysis, methodology, monitoring, conduct and record-keeping
of the clinical investigation ([33] 3.7).
Investigator’s Brochure (IB): Compilation of the current clinical and non-clinical
information on the investigational medical device(s), relevant to the clinical investiga-
tion ([33] 3.25).
Serious Adverse Device Effect (SADE): Adverse device effect that has resulted in any
of the consequences characteristic of a serious adverse event ([33] 3.36).
Serious Adverse Event (SAE): Adverse event that

a. led to death,
b. led to serious deterioration in the health of the subject, that either resulted in
1. a life-threatening illness or injury, or
2. a permanent impairment of a body structure or a body function, or
3. in-patient or prolonged hospitalization, or
4. medical or surgical intervention to prevent life-threatening illness or injury
or permanent impairment to a body structure or a body function,
c. led to fetal distress, fetal death or a congenital abnormality or birth defect ([33]
3.37)

Ref. [33] also notes that the terms “Clinical trial” or “clinical study” are synony-
mous with “clinical investigation.”

26.2 CLINICAL STUDIES
Before we discuss the requirements of risk management for clinical studies, it is
important to understand the different types of clinical studies.