Glossary


TRREE Glossary
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D

Database

Base de données -- Datenbank
A trial results database provides the results of completed studies, and should be accompanied by methodological details to place the results in context. The results may or may not have been peer reviewed. A results database may be separate from a trial register. Thus, a trial may be registered in one register and have its results reported in a different results database.
WHO, International Clinical Trials Registry Platform (ICTRP)

Direct Access

Accès direct-- Direkter Zugang
Permission to examine, analyze, verify, and reproduce any records and reports that are important to evaluation of a clinical trial. Any party (e.g., domestic and foreign regulatory authorities, sponsor's monitors and auditors) with direct access should take all reasonable precautions within the constraints of the applicable regulatory requirement(s) to maintain the confidentiality of subjects' identities and sponsor’s proprietary information.
International Conference on Harmonisation (ICH) – Guideline for Good Clinical Practice (GCP) E6 (R1), Glossary art. 1.21

Direct benefit

Bénéfice direct -- Unmittelbarer Nutzen
A direct benefit to a person’s health signifies not only treatment to cure the patient but also treatment that may alleviate his/her suffering thus improving his/her quality of life.
Additional Protocol to the Convention on Human Rights and Biomedicine, concerning Biomedical Research, explanatory report, Article 6 (risks and benefits)

Documentation

Documentation -- Dokumentation
All records, in any form (including, but not limited to, written, electronic, magnetic, and optical records, and scans, x-rays, and electrocardiograms) that describe or record the methods, conduct, and/or results of a trial, the factors affecting a trial, and the actions taken.
International Conference on Harmonisation (ICH) – Guideline for Good Clinical Practice (GCP) E6 (R1), Glossary art. 1.22

E

Essential Documents

Documents essentiels -- Essentielle Dokumente
Documents which individually and collectively permit evaluation of the conduct of a study and the quality of the data produced.
International Conference on Harmonisation (ICH) – Guideline for Good Clinical Practice (GCP) E6 (R1), Glossary art. 1.23; sec 8

G

Good clinical practice (GCP)

Bonne pratique clinique (BPC) -- Gute Klinische Praxis (GCP)
A standard for the design, conduct, performance, monitoring, auditing, recording, analyses, and reporting of clinical trials that provides assurance that the data and reported results are credible and accurate, and that the rights, integrity, and confidentiality of trial subjects are protected
International Conference on Harmonisation (ICH) – Guideline for Good Clinical Practice (GCP) E6 (R1), art. 1.24

H

Harm

Inconvénients, préjudice, dommage -- Schaden
Which refers to the magnitude of a bad outcome.
Québec health and social services network, Tutorial in research ethics, Resources – Glossary

I

Impartial Witness

Témoin impartial -- Unparteiischer Zeuge
A person, who is independent of the trial, who cannot be unfairly influenced by people involved with the trial, who attends the informed consent process if the subject or the subject’s legally acceptable representative cannot read, and who reads the informed consent form and any other written information supplied to the subject.
International Conference on Harmonisation (ICH) – Guideline for Good Clinical Practice (GCP) E6 (R1), Glossary art. 1.26

Inclusion/exclusion criteria

Critères d’inclusion/exclusion -- Einschlusskriterien/Ausschlusskriterien
The medical or social standards determining whether a person may or may not be allowed to enter a clinical trial. These criteria are based on such factors as age, gender, the type and stage of a disease, previous treatment history, and other medical conditions. It is important to note that inclusion and exclusion criteria are not used to reject people personally, but rather to identify appropriate participants and keep them safe.
US National Institut of Health, ClinicalTrials.gov, Glossary of Clinical Trials Terms

Incompetent adult

Majeur Incapable -- Nicht urteilsfähiger Erwachsener
In the context of research, an incapable adult is an adult who cannot consent to research alone.
Québec health and social services network, Tutorial in research ethics, Resources – Glossary

Independent Data-Monitoring Committee (IDMC) (Data and Safety Monitoring Board, Monitoring Committee, Data Monitoring Committee)

Comité indépendant de contrôle des données (CICD) (Comité de contrôle de l'innocuité et des données, comité de contrôle, comité de contrôle des données) -- Unabhängiges Datenüberwachungskomitee (IDMC)
1) An independent data-monitoring committee that may be established by the sponsor to assess at intervals the progress of a clinical trial, the safety data, and the critical efficacy endpoints, and to recommend to the sponsor whether to continue, modify, or stop a trial.
International Conference on Harmonisation (ICH) – Guideline for Good Clinical Practice (GCP) E6 (R1), art. 1.25
2) One function of such a board is to protect the research subjects from previously unknown adverse reactions or unnecessarily prolonged exposure to an inferior therapy.
CIOMS, International Ethical Guidelines for Biomedical Research Involving Human Subjects, Geneva 2002, Commentary on Guideline 8

Indirect benefit

Bénéfice indirect -- Indirekter Nutzen
Benefits […] include not only direct benefits but also the benefits of the research to science or society. This is particularly relevant in the case of research that has not the potential to produce results of direct benefit for the health of the person concerned.
Additional Protocol to the Convention on Human Rights and Biomedicine, concerning Biomedical Research, explanatory report, Article 6 (risks and benefits)

Informed consent

Consentement éclairé -- Einwilligungserklärung
1) Informed consent is a decision to participate in research, taken by a competent individual who has received the necessary information; who has adequately understood the information; and who, after considering the information, has arrived at a decision without having been subjected to coercion, undue influence or inducement, or intimidation
CIOMS, International Ethical Guidelines for Biomedical Research Involving Human Subjects, Geneva 2002, Commentary on Guideline 4, General considerations
2) A process by which a subject voluntarily confirms his or her willingness to participate in a particular trial, after having been informed of all aspects of the trial that are relevant to the subject's decision to participate. Informed consent is documented by means of a written, signed and dated informed consent form.
International Conference on Harmonisation (ICH) – Guideline for Good Clinical Practice (GCP) E6 (R1), art. 1.28

Inspection

Inspection -- Inspektion
The act by a competent authority of conducting an official review of documents, facilities, records, quality assurance arrangements, and any other resources that are deemed by the competent authority to be related to the clinical trial and that may be located at the site of the trial, at the sponsor's and/or contract research organisation's facilities, or at other establishments which the competent authority sees fit to inspect.
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. 2l


The act by a regulatory authority(ies) of conducting an official review of documents, facilities, records, and any other resources that are deemed by the authority(ies) to be related to the clinical trial and that may be located at the site of the trial, at the sponsor's and/or contract research organization’s (CRO’s) facilities, or at other establishments deemed appropriate by the regulatory authority(ies).
International Conference on Harmonisation (ICH) – Guideline for Good Clinical Practice (GCP) E6 (R1), Glossary art. 1.29

Institution (medical)

Établissement (médical) -- Institution (medizinische)
Any public or private entity or agency or medical or dental facility where clinical trials are conducted.
International Conference on Harmonisation (ICH) – Guideline for Good Clinical Practice (GCP) E6 (R1), Glossary art. 1.30

Interim Clinical Trial/Study Report

Rapport provisoire sur un essai/étude clinique -- Zwischenbericht der klinischen Prüfung / Studie
A report of intermediate results and their evaluation based on analyses performed during the course of a trial.
International Conference on Harmonisation (ICH) – Guideline for Good Clinical Practice (GCP) E6 (R1), Glossary art. 1.32

Investigational Medicinal Product (IMP) / Investigational product

Produit medical de recherche (PMR) / Médicament expérimental / Produit de recherche -- Prüfpräparat
A pharmaceutical form of an active substance or placebo being tested or used as a reference in a clinical trial, including products already with a marketing authorisation but used or assembled (formulated or packaged) in a way different from the authorised form, or when used for an unauthorised indication, or when used to gain further information about the authorised form.
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. 2d


A pharmaceutical form of an active ingredient or placebo being tested or used as a reference in a clinical trial, including a product with a marketing authorization when used or assembled (formulated or packaged) in a way different from the approved form, or when used for an unapproved indication, or when used to gain further information about an approved use.
International Conference on Harmonisation (ICH) – Guideline for Good Clinical Practice (GCP) E6 (R1), art. 1.33

Investigative Product

Produit de recherche -- Prüfpräparat
A pharmaceutical form of an active ingredient or placebo being tested or used as a reference in a clinical trial, including a product with a marketing authorization when used or assembled (formulated or packaged) in a way different from the approved form, or when used for an unapproved indication, or when used to gain further information about an approved use.
International Conference on Harmonisation (ICH) – Guideline for Good Clinical Practice (GCP) E6 (R1), art. 1.33

Investigator

Investigateur -- Untersucher / Prüfer / Prüfarzt
A qualified scientist who undertakes scientific and ethical responsibility, either on his/her own behalf or on behalf of an organization/ firm, for the ethical and scientific integrity of a research project at a specific site or group of sites. In some instances a coordinating or principal investigator may be appointed as the responsible leader of a team of subinvestigators.
WHO, Operational Guidelines for Ethics Committees That Review Biomedical Research, Geneva 2000, TDR/PRD/ETHICS/ 2000, p. 22
2) A person responsible for the conduct of the clinical trial at a trial site. If a trial is conducted by a team of individuals at a trial site, the investigator is the responsible leader of the team and may be called the principal investigator. See also Subinvestigator.
International Conference on Harmonisation (ICH) – Guideline for Good Clinical Practice (GCP) E6 (R1), art. 1.34

Investigator's Brochure

Brochure de l'investigateur-- Prüferinformation (zum Prüfpräparat)
A compilation of the clinical and nonclinical data on the investigational product(s) which is relevant to the study of the investigational product(s) in human subjects.
International Conference on Harmonisation (ICH) – Guideline for Good Clinical Practice (GCP) E6 (R1), Glossary art. 1.36; sec 7
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. 2 g;

Investigator-Institution

Investigateur-établissement -- Prüfer-Institution
An expression meaning "the investigator and/or institution, where required by the applicable regulatory requirements".
International Conference on Harmonisation (ICH) – Guideline for Good Clinical Practice (GCP) E6 (R1), Glossary art. 1.35

J

Justice

Justice -- Gerechtigkeit
Justice refers to the ethical obligation to treat each person in accordance with what is morally right and proper, to give each person what is due to him or her. In the ethics of research involving human subjects the principle refers primarily to distributive justice, which requires the equitable distribution of both the burdens and the benefits of participation in research.
CIOMS, International Ethical Guidelines for Biomedical Research Involving Human Subjects, Geneva 2002, General ethical principles

L

Legally Acceptable Representative

Représentant légal -- Gesetzlicher Vertreter
An individual or juridical or other body authorized under applicable law to consent, on behalf of a prospective subject, to the subject's participation in the clinical trial.
International Conference on Harmonisation (ICH) – Guideline for Good Clinical Practice (GCP) E6 (R1), Glossary art. 1.37

M

Minimal Risk

Risque minimal -- Minimales Risiko
1) It is deemed that the research bears a minimal risk if, having regard to the nature and scale of the intervention, it is to be expected that it will result, at the most, in a very slight and temporary negative impact on the health of the person concerned.
Additional Protocol to the Convention on Human Rights and Biomedicine, concerning Biomedical Research, Article 17/1
2) Intervention risks that do not exceed those associated with routine medical or psychological examination of such persons.
CIOMS, International Ethical Guidelines for Biomedical Research Involving Human Subjects, Geneva 2002, Commentary on Guideline 9

Monitor

Moniteur/ Surveillant -- Monitor
Monitors should be appropriately trained, and should have the scientific and/or clinical knowledge needed to monitor the trial adequately. A monitor’s qualifications should be documented.
International Conference on Harmonisation (ICH) – Guideline for Good Clinical Practice (GCP) E6 (R1), Glossary art. 5.18.2b

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