ISO 14155:2020 Terms and Definitions Flashcards
Adverse Device Effect (ADE)
Adverse event related to the use of an investigational medical device
(Note: This includes adverse events resulting from insufficient or inadequate instructions for use, deployment, implantation, installation, or operation, or any malfunction of the investigational medical device. This also includes any event resulting from use error or from intentional misuse of the investigational medical device.)
Adverse Event (AE)
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 and whether anticipated or unanticipated
Audit
Systematic examination of activities and documents related to a clinical investigation performed by (an) independent person(s), to determine whether these activities were conducted, and the data recorded, analysed and accurately reported, according to the CIP, standard operating procedures, this document and applicable regulatory requirements
Audit Trail
Documentation that allows reconstruction of the course of events
Blinding / Masking
Procedure in which one or more parties to the clinical investigation are kept unaware of the treatment assignment(s)
(Note: Single blinding usually refers to the subject(s) being unaware of the treatment assignment(s). Double blinding usually refers to the subject(s), investigator(s), monitor and, in some cases, centralized assessors being unaware of the treatment assignment(s))
Case Report Form (CRF)
Set of printed, optical or electronic documents for each subject on which information to be reported to the sponsor is recorded, as required by the CIP
Certified Copy
Copy (irrespective of the type of media used) of the original record that has been verified (i.e. by a dated signature or by generation through a validated process) to have the same information including data that describe the context, content, and structure, as the original
Clinical Investigation
Systematic investigation in one or more human subjects, undertaken to assess the clinical performance, effectiveness or safety of a medical device
(aka “clinical trial” or “clinical study”)
Clinical Investigation Plan (CIP)
Document that states the rationale, objectives, design and pre-specified analysis, methodology, organization, monitoring, conduct and record-keeping of the clinical investigation
(aka “protocol”)
Clinical Investigation Report
Document describing the design, execution, statistical analysis and results of a clinical investigation
Clinical Performance
Behaviour of a medical device and response of the subject(s) to that medical device in relation to its intended use, when correctly applied to appropriate subject(s)
Comparator
Medical device, therapy (e.g. active treatment, normal clinical practice), placebo or no treatment, used in the control group in a clinical investigation
Computer System
Hardware and software (including associated documents, e.g. user manual) that creates, modifies, maintains, archives, retrieves, or transmits in digital form information related to the conduct of a clinical investigation
Contract Research Organization (CRO)
Person or organization contracted by the sponsor to perform one or more of the sponsor’s clinical investigation-related duties and functions
Control Group
Group of subjects that receives the comparator
Note: A control group may be concurrent or historical, or subjects may serve as their own control.
Coordinating Investigator
Investigator who is appointed by the sponsor to assist in coordinating the work in a multicenter clinical investigation
Data Monitoring Committee (DMC)
Independent committee that can be established by the sponsor to assess, at intervals, the progress of the clinical investigation, the safety data or the critical clinical performance or effectiveness endpoints and to recommend to the sponsor whether to continue, suspend, modify, or stop the clinical investigation
Deviation
Instance of failure to follow, intentionally or unintentionally, the requirements of the CIP
Device Deficiency
Inadequacy of a medical device with respect to its identity, quality, durability, reliability, usability, safety or performance
(Note: Device deficiencies include malfunctions, use errors, and inadequacy in the information supplied by the manufacturer including labelling.)
Effectiveness
Achievement of a clinically significant intended result in a defined portion of the target population when the investigational medical device is used within its intended uses and according to its instructions for use, the investigator’s brochure and the CIP, as determined by documented scientific evidence
Electronic Record
Combination of text, graphics, data, audio, imaging, or other information in digital form that is created, modified, maintained, archived, retrieved, or distributed by a computer system
Primary Endpoint
Principal indicator(s) used for providing the evidence for clinical performance, effectiveness or safety in a clinical investigation
Secondary Endpoint
Indicator(s) used for assessing the secondary objectives of a clinical investigation
Ethics Committee (EC)
Independent body whose responsibility it is to review clinical investigations in order to protect the rights, safety, and well-being of human subjects participating in a clinical investigation
(aka “research ethics committee”, “independent ethics committee” or “institutional review board”)
Hypothesis
Testable statement, derived from the objective of the clinical investigation to draw a conclusion about this objective, based on a pre-specified statistical test
Independent
Not involved in the development of the investigational device or the conduct of a clinical investigation, except for their specifically assigned responsibilities, in order to avoid bias or a conflict of interest
Informed Consent
Process by which an individual voluntarily confirms willingness to participate in a particular clinical investigation, after having been informed of all aspects of the investigation that are relevant to the decision to participate
Investigation Site
Institution or site where the clinical investigation is carried out
(aka “investigation center”)
Investigational Medical Device
medical device being assessed for clinical performance, effectiveness, or safety in a clinical investigation
Investigator
Individual member of the investigation site team designated and supervised by the principal investigator at an investigation site to perform clinical investigation-related procedures or to make important clinical investigation-related and medical treatment decisions
Investigator’s Brochure (IB)
Compilation of the current clinical and non-clinical information on the investigational medical device(s), relevant to the clinical investigation
Legally Designated Representative
Individual, judicial, or other body authorized under applicable law to consent, on behalf of a prospective subject, to the subject’s participation in the clinical investigation
(aka “legally authorized representative” or “legally acceptable representative”)
Malfunction
Failure of an investigational medical device to perform in accordance with its intended purpose when used in accordance with the instructions for use or CIP, or IB
Medical Device
Instrument, apparatus, implement, machine, appliance, implant, reagent for in vitro use, software, material or other similar or related article, intended by the manufacturer to be used, alone or in combination, for human beings, for one or more of the specific purpose(s) of:
— diagnosis, prevention, monitoring, treatment or alleviation of disease;
— diagnosis, monitoring, treatment, alleviation of or compensation for an injury;
— investigation, replacement, modification, or support of the anatomy or of a physiological process;
— supporting or sustaining life;
— control of conception;
— disinfection of medical devices;
— providing information by means of in vitro examination of specimens derived from the human body;
and does not achieve its primary intended action by pharmacological, immunological or metabolic means, in or on the human body, but which may be assisted in its intended function by such means
Monitoring
Act of overseeing the progress of a clinical investigation to ensure that it is conducted, recorded, and reported in accordance with the CIP, written procedures, this document, and the applicable regulatory requirements
Centralized Monitoring
A remote evaluation of accumulated data and compliance to provide additional monitoring capabilities that can complement or reduce the extent and frequency of on-site monitoring
Multicenter Investigation
Clinical investigation that is conducted according to a single CIP and takes place at two or more investigation sites
Objective
Main purpose for conducting the clinical investigation
Point of Enrollment
Time at which, following recruitment and before any clinical investigation-related procedures are undertaken, a subject signs and dates the informed consent form
Principal Investigator
Qualified person responsible for conducting the clinical investigation at an investigation site
Quality Assurance
Planned and systematic actions that are established to ensure that the clinical investigation is performed, and the data are generated, documented (recorded), and reported in compliance with this document and the applicable regulatory requirement(s)
Quality Control
Operational techniques and activities undertaken within the quality assurance system to verify that the requirements for quality of the clinical investigation-related activities have been fulfilled
Randomization
Process of assigning subjects to the investigational medical device or control groups using an established recognized statistical method using an element of chance to determine the unforeseeable assignment in order to reduce bias
Recruitment
Active efforts to identify subjects who can be suitable for enrolment into the clinical investigation
Serious Adverse Device Effect (SADE)
Adverse device effect that has resulted in any of the consequences characteristic of a serious adverse event
Serious Adverse Event (SAE)
Adverse event that led to any of the following
a) death,
b) serious deterioration in the health of the subject), users, or other persons as defined by one or more of the following:
1) a life-threatening illness or injury, or
2) a permanent impairment of a body structure or a body function including chronic diseases, 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) fetal distress, fetal death, a congenital abnormality, or birth defect including physical or mental impairment
Serious Health Threat
Signal from any adverse event or device deficiency that indicates an imminent risk of death or a serious deterioration in the health in subjects, users or other persons, and that requires prompt remedial action for other subjects, users or other persons
Source Data
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
Source Document
Original or certified copy of printed, optical or electronic document containing source data
(EXAMPLE: 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)
Sponsor
Individual, company, institution or organization taking responsibility and liability for the initiation and management of a clinical investigation, and arranging the financial setup
Subject
Individual who is or becomes a participant in a clinical investigation, either as a recipient of the investigational device or a comparator
Unanticipated Serious Adverse Device Effect (USADE)
Serious adverse device effect which by its nature, incidence, severity or outcome has not been identified in the current risk assessment
Use Error
User action or lack of user action while using the medical device that leads to a different result than that intended by the manufacturer or expected by the user
Validation
Confirmation by examination and provision of objective evidence that the particular requirements for a specific intended use can be consistently fulfilled
Verification
Confirmation by examination and provision of objective evidence that specified requirements have been fulfilled
Vulnerable Subject
Individuals who are unable to fully understand all aspects of the investigation that are relevant to the decision to participate, or who could be manipulated or unduly influenced as a result of a compromised position, expectation of benefits or fear of retaliatory response
