TERMIUM Plus^®

Record 1,  Textual support,  English

Record number: 1, Textual support number: 1 CONT

The general scheme of an add-on clinical trial is shown. Patients with newly diagnosed lupus nephritis (LN) or new flare of LN are given stand-of-care (SOC) therapy and randomized to receive either the experimental drug or placebo.  3, record 1, English, - add%2Don%20clinical%20trial

Record 1,  Textual support,  French

Record 1,  Textual support,  Spanish

Record number: 1, Textual support number: 1 CONT

España autoriza la última fase del ensayo clínico complementario para la vacuna de dos dosis contra la COVID-19 de Johnson & Johnson.  1, record 1, Spanish, - ensayo%20cl%C3%ADnico%20complementario

Record 2,  Textual support,  English

Record number: 2, Textual support number: 1 DEF

A preliminary study of a new treatment conducted in vitro (on cells or tissues) or in vivo (in animals) before clinical trials in humans.  2, record 2, English, - preclinical%20study

Record 2,  Textual support,  French

Record number: 2, Textual support number: 1 DEF

Étude préliminaire d'un nouveau traitement effectuée in vitro (sur des cellules ou des tissus) ou in vivo (chez les animaux) avant les essais cliniques chez l'humain.  2, record 2, French, - %C3%A9tude%20pr%C3%A9clinique

Record 2,  Textual support,  Spanish

Record number: 2, Textual support number: 1 DEF

Prueba de fármaco en experimentación efectuada en probetas o animales, antes de proceder a su ensayo clínico, es decir en seres humanos.  1, record 2, Spanish, - prueba%20precl%C3%ADnica

Record 3,  Textual support,  English

Record number: 3, Textual support number: 1 DEF

Medical experiments performed on human beings.  2, record 3, English, - human%20experimentation

Record number: 3, Textual support number: 1 CONT

Human experimentation is an important part of medical research, and many people volunteer for clinical trials of medical treatments.  2, record 3, English, - human%20experimentation

Record number: 3, Textual support number: 1 OBS

There is always uncertainty about moving from animal to human experimentation or therapy. But in the usual case, what justifies the assumption of this added unknown risk is that the experimental subject is a likely beneficiary of the research, either directly or indirectly.  3, record 3, English, - human%20experimentation

Record 3,  Textual support,  French

Record number: 3, Textual support number: 1 CONT

L'expérimentation humaine [permet] d'évaluer l'utilité thérapeutique réelle d'une méthode mise au point chez l'animal.  2, record 3, French, - exp%C3%A9rimentation%20humaine

Record 3,  Textual support,  Spanish

Record number: 3, Textual support number: 1 DEF

Investigaciones y ensayos médicos sobre hombres y mujeres a fin de prevenir, diagnosticar y tratar las enfermedades.  3, record 3, Spanish, - experimentaci%C3%B3n%20humana

Record number: 3, Textual support number: 1 CONT

El avance en Medicina está fundado en la investigación y por ello no puede prescindir, en muchos casos, de la experimentación sobre seres humanos [...]. El médico está obligado a mantener una clara distinción entre los procedimientos en fase de ensayo y los que ya han sido aceptados como válidos para la práctica concreta de la medicina del momento. El ensayo clínico de nuevos procedimientos no privará al paciente de recibir un tratamiento válido.  2, record 3, Spanish, - experimentaci%C3%B3n%20humana

Record 4,  Textual support,  English

Record number: 4, Textual support number: 1 DEF

An adverse reaction that is classed in nature as serious and which is not consistent with the information about the medicinal product in question set out : (a) in the case of a licensed product, in the summary of product characteristics (SmPC) for that product or, (b) in the case of any other investigational medicinal product, in the IB [Investigator's Brochure] relating to the trial in question.  2, record 4, English, - suspected%20unexpected%20serious%20adverse%20reaction

Record number: 4, Textual support number: 1 CONT

This Standard Operating Procedure (SOP) describes to research staff the procedure for the recording, management and reporting of Adverse Events (AEs), Serious Adverse Events (SAEs), Suspected Serious Adverse Reactions (SSARs) and Suspected Unexpected Serious Adverse Reactions (SUSARs) for clinical trials that fall under the UK Medicines for Human Use (Clinical Trials) Regulations 2004 (SI 2004/1031) and the European Clinical Trials Directive (EUCTD).  2, record 4, English, - suspected%20unexpected%20serious%20adverse%20reaction

Record 4,  Textual support,  French

Record number: 4, Textual support number: 1 CONT

Chaque État membre veille à ce que toutes les suspicions d'effets indésirables graves inattendus d'un médicament expérimental qui ont été portées à sa connaissance soient immédiatement introduites dans une banque européenne de données accessible uniquement aux autorités compétentes des États membres, à l'Agence et à la Commission.  7, record 4, French, - pr%C3%A9somption%20d%27effet%20ind%C3%A9sirable%20grave%20et%20inattendu

Record number: 4, Textual support number: 1 OBS

Même si l'abréviation «SUSAR» provient de l'anglais (suspected unexpected serious adverse reaction), elle est couramment utilisée dans les textes français.  2, record 4, French, - pr%C3%A9somption%20d%27effet%20ind%C3%A9sirable%20grave%20et%20inattendu

Record number: 4, Textual support number: 2 OBS

Les expressions «suspicion d'effet indésirable grave inattendu» et «présomption d'effet indésirable grave inattendu» sont habituellement utilisées au pluriel.  2, record 4, French, - pr%C3%A9somption%20d%27effet%20ind%C3%A9sirable%20grave%20et%20inattendu

Record 4,  Textual support,  Spanish

Record number: 4, Textual support number: 1 CONT

Cuando las sospechas de reacciones adversas graves e inesperadas ocurran en un ensayo clínico doble ciego, se deberá develar el código de tratamiento de ese paciente concreto a efectos de notificación.  1, record 4, Spanish, - sospecha%20de%20reacciones%20adversas%20graves%20e%20inesperadas

Record number: 4, Textual support number: 1 OBS

sospecha de reacciones graves e inesperadas: Término utilizado generalmente en plural.  2, record 4, Spanish, - sospecha%20de%20reacciones%20adversas%20graves%20e%20inesperadas

Record 5,  Textual support,  English

Record number: 5, Textual support number: 1 DEF

Describes an experiment or clinical trial in which animal or human subjects are assigned by chance to separate groups that compare different treatments.  1, record 5, English, - randomized

Record number: 5, Textual support number: 1 CONT

[A] randomized clinical trial [is] a study in which the participants are assigned by chance to separate groups that compare different treatments; neither the researchers nor the participants can choose which group. Using chance to assign people to groups means that the groups will be similar and that the treatments they receive can be compared objectively. At the time of the trial, it is not known which treatment is best. It is the patient's choice to be in a randomized trial.  1, record 5, English, - randomized

Record 5,  Textual support,  French

Record number: 5, Textual support number: 1 DEF

Qui a fait l'objet de randomisation; qui a été randomisé.  2, record 5, French, - randomis%C3%A9

Record number: 5, Textual support number: 1 CONT

Les essais cliniques randomisés constituent la pierre angulaire de l'investigation clinique. C'est ce type de procédure qui fournit la base d'une évaluation causale entre une procédure et son effet.  3, record 5, French, - randomis%C3%A9

Record number: 5, Textual support number: 1 OBS

randomisation : [Validation d'un] résultat par l'étude comparative du résultat obtenu à partir d'un échantillon dont les éléments sont tirés au hasard.  1, record 5, French, - randomis%C3%A9

Record 5,  Textual support,  Spanish

Record number: 5, Textual support number: 1 CONT

En algunos protocolos para medir la efectividad de un fármaco se hacen dos grupos de personas. La selección de quiénes recibirán el medicamento y quiénes un placebo se hace en forma aleatoria.  2, record 5, Spanish, - aleatorio

Record number: 5, Textual support number: 1 PHR

ensayo clínico aleatorio, ensayo clínico aleatorio controlado.  3, record 5, Spanish, - aleatorio