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S

Serious Adverse Event (SAE) / Serious Adverse Drug Reaction (Serious ADR)

Incident thérapeutique grave (ITG) ou réaction indésirable grave à un médicament (RIGM) / Evénement indésirable grave ou effet indésirable grave -- Schwerwiegendes unerwünschtes Ereignis (SUE) oder schwerwiegende unerwünschte Arzneimittelwirkung (schwerwiegende UAW)


Any untoward medical occurrence that at any dose:
  • results in death,
  • is life-threatening,
  • requires inpatient hospitalization or prolongation of existing hospitalization,
  • results in persistent or significant disability/incapacity, or
  • is a congenital anomaly/birth defect
(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. 1.50

Any untoward medical occurrence or effect that at any dose results in death, is life-threatening, requires hospitalisation or prolongation of existing hospitalisation, results in persistent or significant disability or incapacity, or is a congenital anomaly or birth defect.
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. 2o

Source Data

Données de base -- Originaldaten / Quelldaten
All information in original records and certified copies of original records of clinical findings, observations, or other activities in a clinical trial necessary for the reconstruction and evaluation of the trial. Source data are contained in source documents (original records or certified copies).
International Conference on Harmonisation (ICH) – Guideline for Good Clinical Practice (GCP) E6 (R1), Glossary art. 1.51

Source Documents

Documents de base /documents source -- Originaldokumente / Quelldokumente
Original documents, data, and records (e.g., hospital records, clinical and office charts, laboratory notes, memoranda, subjects' diaries or evaluation checklists, pharmacy dispensing records, recorded data from automated instruments, copies or transcriptions certified after verification as being accurate copies, microfiches, photographic negatives, microfilm or magnetic media, x-rays, subject files, and records kept at the pharmacy, at the laboratories and at medico-technical departments involved in the clinical trial).
International Conference on Harmonisation (ICH) – Guideline for Good Clinical Practice (GCP) E6 (R1), Glossary art. 1.52

Sponsor

Promoteur -- Sponsor, Auftraggeber
An individual, company, institution, or organization that takes responsibility for the initiation, management, and/or financing of a research project.
WHO, Operational Guidelines for Ethics Committees That Review Biomedical Research, Geneva 2000, TDR/PRD/ETHICS/ 2000, p. 22
An individual, company, institution or organisation which takes responsibility for the initiation, management and/or financing of a clinical trial.
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. 2e
An individual, company, institution, or organization which takes responsibility for the initiation, management, and/or financing of a clinical trial.
International Conference on Harmonisation (ICH) – Guideline for Good Clinical Practice (GCP) E6 (R1), Glossary art. 1.53

Sponsor-Investigator

Promoteur-investigateur -- Sponsor-Prüfer
An individual who both initiates and conducts, alone or with others, a clinical trial, and under whose immediate direction the investigational product is administered to, dispensed to, or used by a subject. The term does not include any person other than an individual (e.g., it does not include a corporation or an agency). The obligations of a sponsor-investigator include both those of a sponsor and those of an investigator.
International Conference on Harmonisation (ICH) – Guideline for Good Clinical Practice (GCP) E6 (R1), Glossary art. 1.54

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

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