Glossary


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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

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