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Glossary

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:

  • Medical Device Regulation (MDR) 2017/745
  • Medical Device Directive (MDD; Richtlinie 93/42/EWG)
  • Medical Device Act (Medizinproduktegesetz; MPG)
  • MEDDEV 2.7/1 revision 4 (MEDical DEVices)
  • ISO 14155:2020
  • ICH-GCP

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A B C D E F G H I J K L M N O P Q R S T U V W X Y Z
Electronic case report form, eCRF
A software solution to collect and store investigation data
Electronic patient-reported outcomes, ePRO
A functionality of eCRF to enable data entry by investigation subjects, ie. patients 
Adverse device effect - ADE
An adverse device effects describes an adverse event related to the use of an investigational medical device. 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 includes any event resulting from use error or from intentional misuse of the investigational medical device.
Adverse event - AE

An Adverse event (AE) means any untoward medical occurrence, unintended disease or injury or any untoward clinical signs, including an abnormal laboratory finding, in subjects, users or other persons, in the context of a clinical investigation, whether or not related to the investigational device.

For more safety-related terms see also serious adverse event, adverse device effect, serious adverse device effect, device deficiency and incident. 
Amendment
An amendment is a written description of a change(s) to or formal clarification of a protocol.
Anticipated serious adverse device effect - ASADE
An anticipated SADE (ASADE) is an effect which by its nature, incidence, severity or outcome has been previously identified in the risk analysis report.
Approval
An approval is the affirmative decision of the ethics committee that the clinical trial has been reviewed and may be conducted at the institution site.
Audit
An audit is an systematic independent examination of activities and documents related to clinical investigation to determine whether these activities were conducted, and the data recorded, analysed and accurately reported, according to the CIP, standard operating procedures, this International Standard and applicable regulatory requirements.
Audit certificate
A declaration of confirmation by the auditor that an audit has taken place.
Blinding / masking
Procedure in which one or more parties to the clinical investigation are kept unaware of the treatment assignment(s). 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).
Bundesinstitut für Arzneimittel und Medizinprodukte - BfArM
The Federal Institute for Drugs and Medical Devices (in German: Bundesinstitut für Arzneimittel und Medizinprodukte - BfArM) is as an competent authority responsible for clinical investigations of medical devices and for performance evaluations of in vitro diagnostic agents, with the exception of those for which the Paul-Ehrlich-Institute is responsible.
Case report form
The case report form is a document designed to record all information to be reported to the sponsor on each subject as required by the clinical investigation plan.
Certified copy
A copy of the original record that has been verified to have the same information including data that describe the context, content, and structure, as the original. Verfication can be made by a dated signature or by generation through a validated process. The type of media used for the copy is irrespective.
Clinical benefit
A clinical benefit describes the positive impact of a device on the health of an individual. It can be expressed in terms of a meaningful measurable, patient-relevant clinical outcome, including outcome related to diagnosis or a positive impact on patient management or public health.
Clinical data

Clinical data means information concerning safety on performance that is generated from the use of a device. Clinical data can be generated in clinical investigations or other studies which were conducted and / or reported in scientific literature or from post market surveillance like the post market clinical follow-up.

Learn more: read now the guide to Data Management in Clinical Investigations

Clinical evaluation
A clinical evaluation means a systematic and planned process to continuously generate, collect, analyse and assess the clinical data pertaining to a device in order to verify the safety and performance, including clinical benefits, of the device when used as intended by the manufacturer.
Clinical evidence
To allow a qualified assessment of whether the device is safe and achieves the intended clinical benefit(s) claimed by the manufacturer, clinical evidence provided by clinical data and clinical evaluation results pertaining to a device of a sufficient amount and quality.
Clinical investigation
A clinical investigation is any systematic investigation involving one or more human subjects, undertaken to assess the safety and performance of a device.
Clinical investigation plan - CIP
A clinical investigation plan (CIP) displays the rationale, objectives, design, methodology, monitoring, statistical considerations, organization and conduct of a clinical investigation.
Clinical investigation report - CIR
A clinical investigation report (CIR) describes the design, execution, statistical analysis and results of a clinical investigation.
Clinical investigator
The clinical investigator is described as an individual responsible for the conduct of a clinical investigation at a clinical investigation site.
Clinical performance
Clinical performance describes the ability of a medical device to achieve its intended purpose as claimed by the manufacturer.
Clinical safety
Clinical safety is described by the absence of unacceptable clinical risks, when using the device according to the manufacturer’s Instructions for Use.
Clinical trial management system, CTMS
A  software solution to plan and manage the conduct of the investigation
Comparator
The comparator can be a medical device, therapy (e.g. active control), placebo or no treatment, used in the reference group in a clinical investigation.
Competent authority
A competent authority is any person or organization that has the legally delegated or invested authority, capacity, or power to perform a designated function. Clinical investigations for medical devices and performance evaluations of in vitro diagnostic agents in Germany must be approved by the competent authority and approvingly evaluated by an Ethics Committee before they may commence. Competent authorities in Germany are BfArM and PEI.
Compliance
Compliance describes the adherence to all the trial-related requirements, Good Clinical Practice requirements, and the applicable regulatory requirements.
Conformity assessment
Conformity assessment means the process demonstrating whether the requirements of this Regulation relating to a device have been fulfilled.
Contract research organization - CRO
A person or organization contracted by the sponsor to perform one or more of the sponsor's clinical investigation-related duties and functions.
Coordinating (clinical) investigator
Clinical investigator who is appointed by the sponsor to coordinate work in a multicentre clinical investigation.
Corrective action
Corrective action means action taken to eliminate the cause of a potential or actual non-conformity or other undesirable situation.
Corrective and preventive action - CAPA
Corrective and preventive action (CAPA) is a process which investigates and solves problems, identifies causes, takes corrective action and prevents recurrence of the root causes.
Custom-made device
A custom-made device is a medical device which is especially manufactured according to a written prescription and with specific design features and intended for the exclusive use of a patient designated by name. Mass-produced medical devices which need to be adapted to suit the specific requirements of the physician, dentist or other professional user, are not regarded as custom-made medical devices.
Data monitoring committee - DMC

Independent committee that may be established by the sponsor to assess, at intervals, the progress of the clinical investigation, the safety data or the critical performance endpoints and to recommend the sponsor whether to continue, suspend, modify, or stop the clinical investigation. Examples of DMCs are “data safety monitoring board (DSMB)” or “data safety monitoring committee (DSMC)”.

Read now the guide to Data Management in Clinical Investigations

Deviation
A deviation is an instance(s) of failure to follow, intentionally or unintentionally, the requirements of the CIP.
Device deficiency
A device deficiency is described by an inadequacy of a medical device with respect to its identity, quality, durability, reliability, safety or performance. Device deficiencies include malfunctions, use errors, and inadequate labelling.
End point - primary
A primary endpoint describes the principal indicator measured or determined to assess the primary objective of a clinical investigation.
End point - secondary
A secondary endpoint describes the indicator measured or determined in addition to the primary end-point to assess some other objective of a clinical investigation.
Ethics committee
The ethics committee is described by an independent and properly constituted competent body whose responsibility is to ensure that the safety, wellbeing and human rights of the subjects participating in a clinical investigation are protected.
Exclusion criteria
An exclusion criteria is a characteristics of an individual which disqualify them from taking part in a clinical investigation. See also inclusion criteria.
Federal Institute for Drugs and Medical Devices
See Bundesinstitut für Arzneimittel und Medizinprodukte - BfArM
Field safety corrective action
A field safety corrective action means a corrective action taken by a manufacturer for technical or medical reasons to prevent or reduce the risk of a serious incident in relation to a device made available on the market.
Field safety notice
A field safety notice means a communication sent by a manufacturer to users or customers in relation to a field safety corrective action.
IEC 60601 
IEC 60601 is a series of technical standards that describes the requirements for the safety and essential performance of medical electrical equipment. The series consists of a one general standard and about 10 collateral standards that supplement the general standard for all electrical medical equipment. In addition, the series includes 80 particular standards for specific requirements of particular medical electrical devices.
IEC 62366-1
IEC 62366-1:2015 describes the processes for a manufacturer of medical devices to analyze, specify, develop and evaluate the usability of the medical device as it relates to safety. The usability engineering process i.a. human factors engineering guides the manufacturer to identify, assess and mitigate usability risks associated with normal use i.a. correct use and possible use errors and gives the tools to control these risks. The standard is best used together with EC/TR 62366-2 since it provides background information on the methods and hands-on guidance on the implementation of the standard.
Incident
An incident is any malfunction or deterioration in the characteristics or performance of a device made available on the market.
Inclusion criteria
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
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.
Intended purpose
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.
Investigation site
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
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.
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 site file, ISF
A document management system for the study sites
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.
ISO 13485

What is ISO 13485?


The ISO 13485 standard sets a frame for a quality management system for medical devices. It is the most important standard for medical devices. 

ISO 13485:2016 standard sets frames for a quality management system of an organization involved in the life cycle of medical devices. The standard focuses on the requirements that an organization must meet to indicate that the medical device the organization manufactures and and/or its other activities comply with the requirements of the relevant regulations and the customer needs.

The quality management system requirements defined in the standard support the product’s technical, safety and performance requirements, which arise from customer needs and legal requirements. ISO 13485 contains requirements for quality management systems and its related document control, management, managements responsibility, resource management, product realization as well as measurement, analysis, and improvement.

Certification of ISO 13485 quality management system

Organizations involved in the medical device operator chain (manufacturers, distributors, and subcontractors) can certify their quality management system if they wish, i.e., get it evaluated by an external party and have a certificate issued by it. For manufacturers of medical devices, the certification of the quality management system is part of the conformity assessment carried out by the notified body according to the regulations. A certified, ISO 13485 standard compliant quality management system is a requirement – set by EU legislation for the manufacturers of IIa, IIb and III class devices (MDR) or B, C, D (IVDR) class devices.

EN ISO 13485:2016 harmonized with EU legislation (MDR and IVDR) 

The ISO 13485:2016 standard is harmonized with the EU legislation on medical devices and in vitro diagnostic medical devices, which means that by following the standard, the organization meets the specific requirements of the legislation. FDA is also harmonizing its requirements to comply with the ISO 13485:2016 standard.
ISO 14971
ISO 14971 is a key standard for risk management of medical devices. ISO 14971:2019 describes the requirements for risk management throughout the life cycle of a medical device. The purpose is to ensure the safety and performance of the product within the intended use defined by the manufacturer.

Regulations such as MDR and IVDR require consideration of risk management in the operations of organization during the life cycle of a medical device. As part of the organization’s daily operations, risk management aims to ensure controlled solutions and operations in all circumstances.

The ISO 14971 standard can be used to make sure that medical devices that end up on the market are effective and safe, and users and patients are informed about their possible residual risks.

There is a connection between ISO 14971 and ISO 13485 standards. ISO 13485 (as well as the general safety and performance requirements of MDR and IVDR) require well-described and functional risk management. Together, ISO 14971 and ISO 13485 form a functional quality and risk management system that protects equipment users from risks. 

To obtain the ISO 13485:2016 certificate, the organization must apply a risk-based approach to managing the processes required by the quality management system. The ISO 14971 standard supports the risk analysis of devices and the recording of risks in accordance with the ISO 13485 standard.
ISO 15189
ISO 15189 is the quality management standard for medical / clinical laboratories, which places the patient care perspective at its centre. It describes the general and technical requirements for medical/clinical laboratories. Compliance with the standard indicates that the organisation is capable of competent, impartial and consistent operation whose focus is on patient care and patient safety.
ISO 27001
ISO 27001 is an internationally well-known information security standard. The standard defines requirements for the construction, implementation, maintenance and continuous improvement of an information security management system. The standard also sets requirements for assessing and processing information security risks. Thanks to its international renown, the standard also serves as a competitive advantage in the market for medical devices.
ISO 9001
ISO 9001 is a globally well-known basis for effective quality management systems. The standard sets requirements for the quality management system of an organisation and provides tools for building and developing a quality management system. This makes ISO 9001 a good foundation for various management systems (e.g. ISO 13485). Thanks to its international renown, the standard serves as a competitive advantage and a form of positive marketing.
ISO/IEC 17025

The ISO/IEC 17025 standard describes the general and technical requirements for the operation of testing and calibration laboratories, by following which the organization demonstrates that it is capable of competent, impartial and repeatable work. In accordance with the requirements of the standard, the laboratory must plan and implement measures for handling risks and opportunities, thereby increasing the effectiveness of the management system, achieving better results and preventing harmful effects.
Medical device - MD

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.
Patient
A patient describes an individual who participates in a clinical investigation, either as a recipient of the device under investigation or as a control. Synonyme - subject
Paul-Ehrlich-Institute - PEI
The Paul-Ehrlich-Institute (PEI) is a competent authority and responsible for performance evaluations of high risk in vitro diagnostic agents.
Project manager
A project manager is an individual or body with authority, accountability and responsibility for managing a project to achieve specific objectives.
Protocol deviation, PD
A deviation from the clinical investigation protocol
SAE database, serious adverse event database
A database for storing of serious adverse events
Serious adverse event

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

  1. death,
  2. serious deterioration in the health of the subject, that resulted in any of the following:
    1. life-threatening illness or injury,
    2. permanent impairment of a body structure or a body function,
    3. hospitalisation or prolongation of patient hospitalisation,
    4. medical or surgical intervention to prevent life-threatening illness or injury or permanent impairment to a body structure or a body function,
    5. chronic disease,
  3. foetal distress, foetal death or a congenital physical or mental impairment or birth defect.
Serious incident
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
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

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.

Learn more: read now the guide to Data Management in Clinical Investigations

Source document(s)
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.
Sponsor
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.
Standard operating procedure - SOP
Established procedure to be followed in carrying out a given operation or in a given situation.
Subject
A subject describes an individual who participates in a clinical investigation. Synonyme - patient
Technical documentation - TD
Technical documentation represents the entirety of the documents describing a device. The manufacturer supplies information materials, device's design, development, the instruction for use and the regulatory status within target markets. Technical documentation is require for the assessment of conformity to th essential requirements and for the approval of a medical device. Synonyme - technical file
Trial master file - TMF
A trial master file (TMF) is the collection of essential documents that is used by sponsors, CROs and investigators/institutions for the management of the trial and by monitors, auditors and inspectors to review and verify whether the sponsor and the investigators/institutions have conducted the trial in line with the applicable regulatory requirements and the principles and standards of GCP. Unlike the ISF, the TMF remains by the sponsor.
Trial master file, TMF
A document management system for the investigation
Unanticipated serious adverse device effect - USADE
A unanticipated serious adverse device efect (USADE) is a serious adverse device effect which by its nature, incidence, severity or outcome has not been identified in the current version of the risk analysis report.
User
A user describes the person, who can either be a healthcare professional or lay person using the device.
Vulnerable subject

A vulnerable subject is an individual whose willingness to volunteer in a clinical investigation could be unduly influenced by the expectation, whether justified or not, of benefits associated with participation or of retaliatory response from senior members of a hierarchy in case of refusal to participate.

Individuals with lack of or loss of autonomy due to immaturity or through mental disability, persons in nursing homes, children, impoverished persons, subjects in emergency situations, ethnic minority groups, homeless persons, nomads, refugees, and those incapable of giving informed consent.

Other vulnerable subjects include, for example, members of a group with a hierarchical structure such as university students, subordinate hospital and laboratory personnel, employees of the sponsor, members of the armed forces, and persons kept in detention.
Withdrawal
A withdrawal describes any measure aimed at preventing a device in the supply chain from being further made available on the market.