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

B

Beneficence

Bienfaisance -- Fürsorgliches Handeln
1) Beneficence refers to the ethical obligation to maximize benefits and to minimize harms.
CIOMS, International Ethical Guidelines for Biomedical Research Involving Human Subjects, Geneva 2002, General ethical principles
2) Literally, ‘doing good’. Physicians are expected to act in the best interests of their patients.
World Medical Association, Medical Ethics Manual, Ferney-Voltaire, WMA, 2nd ed., 2009, Appendix A, Glossary

Benefit

Bénéfice / avantage -- Nutzen / Vorteil
Which refers to the magnitude of a good outcome.

Blinding / Masking

Essai à l’insu / essai en aveugle -- Verblindung
A procedure in which one or more parties to the trial are kept unaware of the treatment assignment(s). Single-blinding usually refers to the subject(s) being unaware, and double-blinding usually refers to the subject(s), investigator(s), monitor, and, in some cases, data analyst(s) being unaware of the treatment assignment(s).
International Conference on Harmonisation (ICH) – Guideline for Good Clinical Practice (GCP) E6 (R1), Glossary art. 1.10

C

Case Report Form (CRF)

Formulaire d’exposé de cas (FEC) -- Prüfbogen (CRF)
A printed, optical, or electronic document designed to record all of the protocol required information to be reported to the sponsor on each trial subject.
International Conference on Harmonisation (ICH) – Guideline for Good Clinical Practice (GCP) E6 (R1), Glossary, art. 1.11

Clinical Equipoise

Equilibre clinique -- Klinisches Gleichgewicht (Klinische Gleichwertigkeit)
Clinical equipoise means a genuine uncertainty on the part of the expert medical community about the comparative therapeutic merits of each arm of a clinical trial. The tenet of clinical equipoise provides a clear moral foundation to the requirement that the health care of subjects not be disadvantaged by research participation.
Québec health and social services network, Tutorial in research ethics, Resources – Glossary

Clinical Trial/Study

Essai/étude clinique -- Klinische Prüfung / Studie
Any investigation in human subjects intended to discover or verify the clinical, pharmacological and/or other pharmacodynamic effects of an investigational product(s), and/or to identify any adverse reactions to an investigational product(s), and/or to study absorption, distribution, metabolism, and excretion of an investigational product(s) with the object of ascertaining its safety and/or efficacy. The terms clinical trial and clinical study are synonymous.
International Conference on Harmonisation (ICH) – Guideline for Good Clinical Practice (GCP) E6 (R1), art. 1.12
Any investigation in human subjects intended to discover or verify the clinical, pharmacological and/or other pharmacodynamic effects of one or more investigational medicinal product(s), and/or to identify any adverse reactions to one or more investigational medicinal product(s) and/or to study absorption, distribution, metabolism and excretion of one or more investigational medicinal product(s) with the object of ascertaining its (their) safety and/or efficacy.

This includes clinical trials carried out in either one site or multiple sites, whether in one or more than one Member State.
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. 2a

Clinical Trial/Study Report

Rapport sur un essai/étude clinique -- Klinischer Prüfungs- / Studienbericht
A written description of a trial/study of any therapeutic, prophylactic, or diagnostic agent conducted in human subjects, in which the clinical and statistical description, presentations, and analyses are fully integrated into a single report (see the ICH Guideline for Structure and Content of Clinical Study Reports).
International Conference on Harmonisation (ICH) – Guideline for Good Clinical Practice (GCP) E6 (R1), Glossary art. 1.13

Community

Communauté -- Gemeinschaft
A community is a group of people understood as having a certain identity due to the sharing of common interests or to a shared proximity. A community may be identified as a group of people living in the same village, town, or country and, thus, sharing geographical proximity. A community may be otherwise identified as a group of people sharing a common set of values, a common set of interests, or a common disease.
WHO, Operational Guidelines for Ethics Committees That Review Biomedical Research, Geneva 2000, TDR/PRD/ETHICS/ 2000, p. 21

Comparator (Product)

Comparateur (produit) -- Vergleichspräparat
An investigational or marketed product (i.e., active control), or placebo, used as a reference in a clinical trial.
International Conference on Harmonisation (ICH) – Guideline for Good Clinical Practice (GCP) E6 (R1), Glossary art. 1.14

Competent authorities/ Regulatory authorities

Autorités compétentes / Organisme de réglementation -- 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

Compliance (in relation to trials)

Conformité (concernant les essais) -- Compliance (in bezug auf klinische Prüfungen)
Adherence to all the trial-related requirements, Good Clinical Practice (GCP) requirements, and the applicable regulatory requirements.
International Conference on Harmonisation (ICH) – Guideline for Good Clinical Practice (GCP) E6 (R1), Glossary art. 1.15

Confidentiality

Confidentialité -- Vertraulichkeit
Principle according to which personal information can only be disclosed with the informed consent of the person concerned and solely to authorized persons.

Conflict of interest

Conflit d’intérêts -- Interessenkonflikt
1) "Set of conditions in which professional judgment concerning a primary interest tends to be unduly influenced by a secondary interest."D.F. Thompson, "Understanding financial conflicts of interest" (1993) 329 New England Journal of Medicine 573-6,
Québec health and social services network, Tutorial in research ethics, Resources – Glossary
2) A conflict of interest arises when a member (or members) of the EC holds interests with respect to specific applications for review that may jeopardize his/her (their) ability to provide a free and independent evaluation of the research focused on the protection of the research participants. Conflicts of interests may arise when an EC member has financial, material, institutional, or social ties to the research.
WHO, Operational Guidelines for Ethics Committees That Review Biomedical Research, Geneva 2000, TDR/PRD/ETHICS/ 2000, p. 21

Contract

Contrat - Vertrag
A written, dated, and signed agreement between two or more involved parties that sets out any arrangements on delegation and distribution of tasks and obligations and, if appropriate, on financial matters. The protocol may serve as the basis of a contract.
International Conference on Harmonisation (ICH) – Guideline for Good Clinical Practice (GCP) E6 (R1), Glossary art. 1.17

Contract research organization (CRO)

Organisme de recherche sous contrat (ORC) -- Auftragsforschungsinstitut (CRO)
A person or an organization (commercial, academic, or other) contracted by the sponsor to perform one or more of a sponsor's trial-related duties and functions.
International Conference on Harmonisation (ICH) – Guideline for Good Clinical Practice (GCP) E6 (R1), art. 1.20

Coordinating Committee

Comité de coordination -- Koordinierungsausschuß
A committee that a sponsor may organize to coordinate the conduct of a multicentre trial.
International Conference on Harmonisation (ICH) – Guideline for Good Clinical Practice (GCP) E6 (R1), Glossary art. 1.18

Coordinating Investigator

Investigateur chargé de la coordination -- Koordinierender Prüfer
An investigator assigned the responsibility for the coordination of investigators at different centers participating in a multicentre trial.
International Conference on Harmonisation (ICH) – Guideline for Good Clinical Practice (GCP) E6 (R1), Glossary art. 1.19


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