Glossary


TRREE Glossary
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M

Monitoring

Surveillance / monitoring -- Monitoring
The act of overseeing the progress of a clinical trial, and of ensuring that it is conducted, recorded, and reported in accordance with the protocol, Standard Operating Procedures (SOPs), Good Clinical Practice (GCP), and the applicable regulatory requirement(s).
International Conference on Harmonisation (ICH) – Guideline for Good Clinical Practice (GCP) E6 (R1), Glossary art. 1.38

Monitoring Report

Rapport de surveillance/rapport de monitoring -- Monitor-Bericht
A written report from the monitor to the sponsor after each site visit and/or other trial-related communication according to the sponsor’s SOPs.
International Conference on Harmonisation (ICH) – Guideline for Good Clinical Practice (GCP) E6 (R1), Glossary art. 1.39

Multi-centre clinical trial / Multicentre Trial

Essai clinique multicentrique / Essai multicentrique -- Multizentrische klinische Prüfung / Multizentrische Studie
A clinical trial conducted according to a single protocol but at more than one site, and therefore by more than one investigator, in which the trial sites may be located in a single Member State, in a number of Member States and/or in Member States and third countries.
Directive 2001/20/EC of the European Parliament and of the Council of 4 April 2001 on the approximation of the laws, regulations and administrative provisions of the Member States relating to the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use, art. 2b


A clinical trial conducted according to a single protocol but at more than one site, and therefore, carried out by more than one investigator.
International Conference on Harmonisation (ICH) – Guideline for Good Clinical Practice (GCP) E6 (R1), Glossary art. 1.40

N

Non-interventional trial

Essai non-interventionnel -- Nicht-interventionelle Prüfung
A study where the medicinal product(s) is (are) prescribed in the usual manner in accordance with the terms of the marketing authorisation. The assignment of the patient to a particular therapeutic strategy is not decided in advance by a trial protocol but falls within current practice and the prescription of the medicine is clearly separated from the decision to include the patient in the study. No additional diagnostic or monitoring procedures shall be applied to the patients and epidemiological methods shall be used for the analysis of collected data.
Directive 2001/20/EC of the European Parliament and of the Council of 4 April 2001 on the approximation of the laws, regulations and administrative provisions of the Member States relating to the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use, art. 2c

Non-maleficence

Non-malfaisance -- Primum nil nocere-Prinzip, Schadensvermeidung
1) This principle proscribes the deliberate infliction of harm on persons
CIOMS, International Ethical Guidelines for Biomedical Research Involving Human Subjects, Geneva 2002, General ethical principles
2) literally, not doing wrong. Physicians and medical researchers are to avoid inflicting harm on patients and research subjects.
World Medical Association, Medical Ethics Manual, Ferney-Voltaire, WMA, 2nd ed., 2009, Appendix A, Glossary

Non-therapeutic procedures

Interventions non thérapeutiques -- Nichttherapeutische Massnahmen
Actions that go beyond the needs of the patient- participant, and that are incurred only for the needs of the research.
Québec health and social services network, Tutorial in research ethics, Resources – Glossary

Nonclinical Study

Étude non clinique -- Präklinische Prüfung
Biomedical studies not performed on human subjects.
International Conference on Harmonisation (ICH) – Guideline for Good Clinical Practice (GCP) E6 (R1), Glossary art. 1.41

O

Opinion (in relation to Independent Ethics Committee)

Opinion (du comité d'éthique indépendant) -- Bewertung (in bezug auf die unabhängige Ethik-Kommission)
The judgement and/or the advice provided by an Independent Ethics Committee (IEC).
International Conference on Harmonisation (ICH) – Guideline for Good Clinical Practice (GCP) E6 (R1), Glossary art. 1.42

P

Personal data (Personal information)

Données personnelles -- Personenbezogene Daten
Any information relating to an identified or identifiable natural person ('data subject'); an identifiable person is one who can be identified, directly or indirectly, in particular by reference to an identification number or to one or more factors specific to his physical, physiological, mental, economic, cultural or social identity.
Directive 95/46/EC of the European Parliament and of the Council of 24 October 1995 on the protection of individuals with regard to the processing of personal data and on the free movement of such data

Placebo

Placebo -- Placebo
A chemically inert substance given in the guise of medicine for its psychologically suggestive effect. Placebos are used in controlled clinical trials to determine whether improvement and side effects may reflect imagination or anticipation rather than actual power of a drug.
NEBRA: Networking for Ethics on Biomedical Research in Africa, Presentation of the NEBRA Project - nebra-booklet (english) p. 15

Protocol

Protocole -- Protokoll/Prüfplan
1) A document that provides the background, rationale, and objective(s) of a biomedical research project and describes its design, methodology, and organization, including ethical and statistical considerations. Some of these considerations may be provided in other documents referred to in the protocol.
WHO, Operational Guidelines for Ethics Committees That Review Biomedical Research, Geneva 2000, TDR/PRD/ETHICS/ 2000, p. 22
2) A document that describes the objective(s), design, methodology, statistical considerations, and organization of a trial. The protocol usually also gives the background and rationale for the trial, but these could be provided in other protocol referenced documents.
International Conference on Harmonisation (ICH) – Guideline for Good Clinical Practice (GCP) E6 (R1), art. 1.44
3) A document that describes the objective(s), design, methodology, statistical considerations and organisation of a trial. The term protocol refers to the protocol, successive versions of the protocol and protocol amendments.
Directive 2001/20/EC of the European Parliament and of the Council of 4 April 2001 on the approximation of the laws, regulations and administrative provisions of the Member States relating to the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use, art. 2h

Protocol Amendment

Amendement / modification au protocole -- Protokoll-Amendment / Prüfplanänderung
1) A written description of a change to, or formal clarification of, a protocol.
WHO, Operational Guidelines for Ethics Committees That Review Biomedical Research, Geneva 2000, TDR/PRD/ETHICS/ 2000, p. 22
2) A written description of a change(s) to or formal clarification of a protocol.
International Conference on Harmonisation (ICH) – Guideline for Good Clinical Practice (GCP) E6 (R1), art. 1.45

Q

Quality Assurance (QA)

Assurance de la qualité (AQ)-- Qualitätssicherung (QA)
All those planned and systematic actions that are established to ensure that the trial is performed and the data are generated, documented (recorded), and reported in compliance with Good Clinical Practice (GCP) and the applicable regulatory requirement(s).
International Conference on Harmonisation (ICH) – Guideline for Good Clinical Practice (GCP) E6 (R1), Glossary art. 1.46

Quality Control (QC)

Contrôle de la qualité (CQ) -- Qualitätskontrolle (QC)
The operational techniques and activities undertaken within the quality assurance system to verify that the requirements for quality of the trial-related activities have been fulfilled.
International Conference on Harmonisation (ICH) – Guideline for Good Clinical Practice (GCP) E6 (R1), Glossary art. 1.47

R

Randomization

Distribution au hasard -- Randomisierung
The process of assigning trial subjects to treatment or control groups using an element of chance to determine the assignments in order to reduce bias.
International Conference on Harmonisation (ICH) – Guideline for Good Clinical Practice (GCP) E6 (R1), Glossary art. 1.48

Regulatory Authorities

Organisme de réglementation / autorité compétente -- Zuständige Behörden
Bodies having the power to regulate. In the ICH GCP guideline the expression Regulatory Authorities includes the authorities that review submitted clinical data and those that conduct inspections (see 1.29). These bodies are sometimes referred to as competent authorities.
International Conference on Harmonisation (ICH) – Guideline for Good Clinical Practice (GCP) E6 (R1), Glossary art. 1.49

Research

Recherche -- Forschung
1) The term "research" refers to a class of activity designed to develop or contribute to generalizable knowledge. Generalizable knowledge consists of theories, principles or relationships, or the accumulation of information on which they are based, that can be corroborated by accepted scientific methods of observation and inference. In the present context "research" includes both medical and behavioural studies pertaining to human health. Usually "research" is modified by the adjective "biomedical" to indicate its relation to health.
CIOMS, International Ethical Guidelines for Biomedical Research Involving Human Subjects, Geneva 2002, Preamble
2) The primary purpose of medical research involving human subjects is to understand the causes, development and effects of diseases and improve preventive, diagnostic and therapeutic interventions (methods, procedures and treatments). Even the best current interventions must be evaluated continually through research for their safety, effectiveness, efficiency, accessibility and quality.
Declaration of Helsinki, 2008 par. 7

Research Ethics Committee (REC) / Independent Ethics Committee (IEC) / Institutional review Board (IRB)

Comité d'éthique de la recherche (CER) / comité d’éthique indépendant (CEI) / comité d’examen de l’établissement (CEE) -- Forschungsethikkommission / Unabhängige Ethik-Kommission / Institutionell Review Board
An independent body (a review board or a committee, institutional, regional, national, or supranational), constituted of medical professionals and non-medical members, whose responsibility it is to ensure the protection of the rights, safety and well-being of human subjects involved in a trial and to provide public assurance of that protection, by, among other things, reviewing and approving / providing favourable opinion on, the trial protocol, the suitability of the investigator(s), facilities, and the methods and material to be used in obtaining and documenting informed consent of the trial subjects.
International Conference on Harmonisation (ICH) – Guideline for Good Clinical Practice (GCP) E6 (R1), art. 1.27

Research participant / Research subject / Subject/Trial Subject

Participant à la recherche / sujet de recherche -- Sujet/sujet participant à l’essai -- Teilnehmende/r an Forschungsprojekten / Versuchsperson / Prüfungsteilnehmer
An individual who participates in a biomedical research project, either as the direct recipient of an intervention (e.g., study product or invasive procedure), as a control, or through observation. The individual may be a healthy person who volunteers to participate in the research, or a person with a condition unrelated to the research carried out who volunteers to participate, or a person (usually a patient) whose condition is relevant to the use of the study product or questions being investigated.
WHO, Operational Guidelines for Ethics Committees That Review Biomedical Research, Geneva 2000, TDR/PRD/ETHICS/ 2000, p. 22
An individual who participates in a clinical trial, either as a recipient of the investigational product(s) or as a control.
International Conference on Harmonisation (ICH) – Guideline for Good Clinical Practice (GCP) E6 (R1), Glossary art. 1.57

Risk

Risque -- Risiko
1) Which refers to the probability of harm.
Québec health and social services network, Tutorial in research ethics, Resources – Glossary
2) The probability and extent of harm or injury (physical, psychological, social, or economic) occurring as a result of participation in a research study. Both the probability and extent of possible harm may vary from minimal to significant.
NEBRA: Networking for Ethics on Biomedical Research in Africa, Presentation of the NEBRA Project - nebra-booklet (english) p. 15

S

Serious Adverse Event (SAE) / Serious Adverse Drug Reaction (Serious ADR)

Incident thérapeutique grave (ITG) ou réaction indésirable grave à un médicament (RIGM) / Evénement indésirable grave ou effet indésirable grave -- Schwerwiegendes unerwünschtes Ereignis (SUE) oder schwerwiegende unerwünschte Arzneimittelwirkung (schwerwiegende UAW)


Any untoward medical occurrence that at any dose:
  • results in death,
  • is life-threatening,
  • requires inpatient hospitalization or prolongation of existing hospitalization,
  • results in persistent or significant disability/incapacity, or
  • is a congenital anomaly/birth defect
(see the ICH Guideline for Clinical Safety Data Management: Definitions and Standards for Expedited Reporting).
International Conference on Harmonisation (ICH) – Guideline for Good Clinical Practice (GCP) E6 (R1), Glossary art. 1.50

Any untoward medical occurrence or effect that at any dose results in death, is life-threatening, requires hospitalisation or prolongation of existing hospitalisation, results in persistent or significant disability or incapacity, or is a congenital anomaly or birth defect.
Directive 2001/20/EC of the European Parliament and of the Council of 4 April 2001 on the approximation of the laws, regulations and administrative provisions of the Member States relating to the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use, art. 2o

Source Data

Données de base -- Originaldaten / Quelldaten
All information in original records and certified copies of original records of clinical findings, observations, or other activities in a clinical trial necessary for the reconstruction and evaluation of the trial. Source data are contained in source documents (original records or certified copies).
International Conference on Harmonisation (ICH) – Guideline for Good Clinical Practice (GCP) E6 (R1), Glossary art. 1.51

Source Documents

Documents de base /documents source -- Originaldokumente / Quelldokumente
Original documents, data, and records (e.g., hospital records, clinical and office charts, laboratory notes, memoranda, subjects' diaries or evaluation checklists, pharmacy dispensing records, recorded data from automated instruments, copies or transcriptions certified after verification as being accurate copies, microfiches, photographic negatives, microfilm or magnetic media, x-rays, subject files, and records kept at the pharmacy, at the laboratories and at medico-technical departments involved in the clinical trial).
International Conference on Harmonisation (ICH) – Guideline for Good Clinical Practice (GCP) E6 (R1), Glossary art. 1.52

Sponsor

Promoteur -- Sponsor, Auftraggeber
An individual, company, institution, or organization that takes responsibility for the initiation, management, and/or financing of a research project.
WHO, Operational Guidelines for Ethics Committees That Review Biomedical Research, Geneva 2000, TDR/PRD/ETHICS/ 2000, p. 22
An individual, company, institution or organisation which takes responsibility for the initiation, management and/or financing of a clinical trial.
Directive 2001/20/EC of the European Parliament and of the Council of 4 April 2001 on the approximation of the laws, regulations and administrative provisions of the Member States relating to the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use, art. 2e
An individual, company, institution, or organization which takes responsibility for the initiation, management, and/or financing of a clinical trial.
International Conference on Harmonisation (ICH) – Guideline for Good Clinical Practice (GCP) E6 (R1), Glossary art. 1.53

Sponsor-Investigator

Promoteur-investigateur -- Sponsor-Prüfer
An individual who both initiates and conducts, alone or with others, a clinical trial, and under whose immediate direction the investigational product is administered to, dispensed to, or used by a subject. The term does not include any person other than an individual (e.g., it does not include a corporation or an agency). The obligations of a sponsor-investigator include both those of a sponsor and those of an investigator.
International Conference on Harmonisation (ICH) – Guideline for Good Clinical Practice (GCP) E6 (R1), Glossary art. 1.54

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