Glossary


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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

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

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