Glossary


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S

Standard Operating Procedures (SOPs)

Modes opératoires normalisés (MON) -- Standardarbeitsanweisungen (SOPs)
Detailed, written instructions to achieve uniformity of the performance of a specific function.
International Conference on Harmonisation (ICH) – Guideline for Good Clinical Practice (GCP) E6 (R1), art. 1.55

Subinvestigator

Investigateur secondaire -- Zweitprüfer
Any individual member of the clinical trial team designated and supervised by the investigator at a trial site to perform critical trial-related procedures and/or to make important trial-related decisions (e.g., associates, residents, research fellows). See also Investigator.
International Conference on Harmonisation (ICH) – Guideline for Good Clinical Practice (GCP) E6 (R1), Glossary art. 1.56

Subject Identification Code

Code d’identification du sujet -- Identifizierungscode für die Prüfungsteilnehmer
A unique identifier assigned by the investigator to each trial subject to protect the subject's identity and used in lieu of the subject's name when the investigator reports adverse events and/or other trial related data.
International Conference on Harmonisation (ICH) – Guideline for Good Clinical Practice (GCP) E6 (R1), Glossary art. 1.58

Subject/Trial Subject/ Research participant / Research subject

Sujet/sujet participant à l’essai/ Participant à la recherche / sujet de recherche -- Prüfungsteilnehmer/ Teilnehmende/r an Forschungsprojekten / Versuchsperson
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


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

T

Transparency

Transparence -- Transparenz
An ethical principle that encourages decision-makers to make their decision-making process open and accessible to the public, through clear and frequent communication of information about the way decisions are made and the reasons for decisions.
NEBRA: Networking for Ethics on Biomedical Research in Africa, Presentation of the NEBRA Project - nebra-booklet (english) p. 15

Trial Site

Lieu de l’essai -- Prüfzentrum
The location(s) where trial-related activities are actually conducted.
International Conference on Harmonisation (ICH) – Guideline for Good Clinical Practice (GCP) E6 (R1), Glossary art. 1.59

U

Unexpected Adverse Drug Reaction / Unexpected adverse reaction

Effet indésirable inattendu -- Unerwartete Nebenwirkung
An adverse reaction, the nature or severity of which is not consistent with the applicable product information (e.g. investigator's brochure for an unauthorised investigational product or summary of product characteristics for an authorised product).
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. 2p

V

Voluntary / free

Volontaire / libre -- Freiwillig / frei
Free of coercion, duress, or undue inducement. Used in the research context to refer to a person's decision to participate (or to continue to participate) in a research activity.
NEBRA: Networking for Ethics on Biomedical Research in Africa, Presentation of the NEBRA Project - nebra-booklet (english) p. 15

Vulnerability

Vulnérabilité -- Verletzlichkeit
1) "Vulnerability" refers to a substantial incapacity to protect one's own interests owing to such impediments as lack of capability to give informed consent, lack of alternative means of obtaining medical care or other expensive necessities, or being a junior or subordinate member of a hierarchical group.
CIOMS, International Ethical Guidelines for Biomedical Research Involving Human Subjects, Geneva 2002, General ethical principles
2) Vulnerable subjects are individuals whose willingness to volunteer in a clinical trial may be unduly influenced by the expectation, whether justified or not, of benefits associated with participation, or of a retaliatory response from senior members of a hierarchy in case of refusal to participate.
International Conference on Harmonisation (ICH) – Guideline for Good Clinical Practice (GCP) E6 (R1), art. 1.61
3) Vulnerable persons are those who are relatively (or absolutely) incapable of protecting their own interests. More formally, they may have insufficient power, intelligence, education, resources, strength, or other needed attributes to protect their own interests.
CIOMS, International Ethical Guidelines for Biomedical Research Involving Human Subjects, Geneva 2002, Commentary on Guideline 9

Vulnerable Subjects

Sujets vulnérables -- Schutzbedürftige Prüfungsteilnehmer
Individuals whose willingness to volunteer in a clinical trial may be unduly influenced by the expectation, whether justified or not, of benefits associated with participation, or of a retaliatory response from senior members of a hierarchy in case of refusal to participate. Examples are members of a group with a hierarchical structure, such as medical, pharmacy, dental, and nursing students, subordinate hospital and laboratory personnel, employees of the pharmaceutical industry, members of the armed forces, and persons kept in detention. Other vulnerable subjects include patients with incurable diseases, persons in nursing homes, unemployed or impoverished persons, patients in emergency situations, ethnic minority groups, homeless persons, nomads, refugees, minors, and those incapable of giving consent.
International Conference on Harmonisation (ICH) – Guideline for Good Clinical Practice (GCP) E6 (R1), Glossary art. 1.61

W

Well-being (of the trial subjects)

Bien-être (des sujets participant à l’essai)-- Wohl der Prüfungsteilnehmer
The physical and mental integrity of the subjects participating in a clinical trial.
International Conference on Harmonisation (ICH) – Guideline for Good Clinical Practice (GCP) E6 (R1), Glossary art. 1.62

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