TERMIUM Plus^®

Record 1,  Textual support,  English

Record number: 1, 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 1, English, - suspected%20unexpected%20serious%20adverse%20reaction

Record number: 1, 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 1, English, - suspected%20unexpected%20serious%20adverse%20reaction

Record 1,  Textual support,  French

Record number: 1, 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 1, French, - pr%C3%A9somption%20d%27effet%20ind%C3%A9sirable%20grave%20et%20inattendu

Record number: 1, 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 1, French, - pr%C3%A9somption%20d%27effet%20ind%C3%A9sirable%20grave%20et%20inattendu

Record number: 1, 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 1, French, - pr%C3%A9somption%20d%27effet%20ind%C3%A9sirable%20grave%20et%20inattendu

Record 1,  Textual support,  Spanish

Record number: 1, 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 1, Spanish, - sospecha%20de%20reacciones%20adversas%20graves%20e%20inesperadas

Record number: 1, Textual support number: 1 OBS

sospecha de reacciones graves e inesperadas: Término utilizado generalmente en plural.  2, record 1, Spanish, - sospecha%20de%20reacciones%20adversas%20graves%20e%20inesperadas