Glossary


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A

Adverse Event (AE)

Incident thérapeutique (IT)/ Événement indésirable -- Unerwünschtes Ereignis (UE)
Any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment.
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. 2m


Any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An adverse event (AE) can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product (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. 1.2

Adverse Reaction / Adverse Drug Reaction (ADR)

Effet indésirable / Réaction indésirable à un medicament (RIM) -- Nebenwirkung / Unerwünschte Arzneimittelwirkung (UAW)


In the pre-approval clinical experience with a new medicinal product or its new usages, particularly as the therapeutic dose(s) may not be established: all noxious and unintended responses to a medicinal product related to any dose should be considered adverse drug reactions. The phrase responses to a medicinal product means that a causal relationship between a medicinal product and an adverse event is at least a reasonable possibility, i.e. the relationship cannot be ruled out. Regarding marketed medicinal products: a response to a drug which is noxious and unintended and which occurs at doses normally used in man for prophylaxis, diagnosis, or therapy of diseases or for modification of physiological function
International Conference on Harmonisation (ICH) – Guideline for Good Clinical Practice (GCP) E6 (R1), art. 1.1


All untoward and unintended responses to an investigational medicinal product related to any dose administered;
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. 2n

Applicable Regulatory Requirement(s)

Exigence réglementaire applicable -- Geltende gesetzliche Bestimmungen
Any law(s) and regulation(s) addressing the conduct of clinical trials of investigational products.
International Conference on Harmonisation (ICH) – Guideline for Good Clinical Practice (GCP) E6 (R1), Glossary art. 1.4

Approval (of a research ethics committee)

Approbation (d’un comité d'éthique de la recherche) -- Genehmigung (einer Forschungsethikkommission)
The affirmative decision of the Research Ethics Committee (REC) that the clinical trial has been reviewed and may be conducted within the constraints set forth by the REC, the institution, Good Clinical Practice (GCP), and the applicable regulatory requirements.

Audit

Audit / vérification -- Audit
A systematic and independent examination of trial related activities and documents to determine whether the evaluated trial related activities were conducted, and the data were recorded, analyzed and accurately reported according to the protocol, sponsor's 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. 1.6

Audit Certificate

Certificat d'audit/ Certificat de vérification -- Audit-Zertifikat
A declaration of confirmation by the auditor that an audit has taken place.
International Conference on Harmonisation (ICH) – Guideline for Good Clinical Practice (GCP) E6 (R1), Glossary art. 1.7

Audit Report

rapport d'audit/ Rapport de vérification -- Audit-Bericht
A written evaluation by the sponsor's auditor of the results of the audit.
International Conference on Harmonisation (ICH) – Guideline for Good Clinical Practice (GCP) E6 (R1), Glossary art. 1.8

Audit Trail

Piste de vérification / piste d'audit -- Audit-Trail
Documentation that allows reconstruction of the course of events.
International Conference on Harmonisation (ICH) – Guideline for Good Clinical Practice (GCP) E6 (R1), Glossary art. 1.9

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