modificación sustancial

English translation: substantial modification/amendment

GLOSSARY ENTRY (DERIVED FROM QUESTION BELOW)
Spanish term or phrase:modificación sustancial
English translation:substantial modification/amendment
Entered by: EirTranslations

18:46 Nov 13, 2018
Spanish to English translations [PRO]
Medical - Medical (general) / clinical trial
Spanish term or phrase: modificación sustancial
Also appears as a heading later on in the document see below thanks

xxx, titular de la Secretaría Técnica del Comité de Ética de la Investigación con medicamentos del xxx,
CERTIFICA
Que este Comité, ha evaluado la propuesta del promotor xxx.
relativa a la modificación sustancial con n° MODIFICACIÓN SUSTANCIAL xxx2018, correspondiente al ensayo clínico con código de protocolo xxx, titulado:
“ESTUDIO CLÍNICO DE FASE II, ALEATORIZADO, BASADO EN BIOMARCADORES, EN PACIENTES CON xxx RECIDIVANTE O RESISTENTE CON UN GRUPO EXPLORATORIO PARA PACIENTES CON DIAGNÓSTICO RECIENTE DE xxx Y GRUPOS EXPLORATORIOS CON GRADOS DIVERSOS DE DEPENDENCIA DE xxx."
EirTranslations
Ireland
Local time: 01:58
substantial modification/amendment
Explanation:
I think the difference depends on whether the text of the clinical trial protocol is changed (amendment), or the actual protocol is changed (modification).
See Emma Goldsmith's piece on it here:

"Substantial amendment/substantial modification: the same or different?

On the surface, the term modification appears to have replaced amendment in the new Regulation. Substantial modification even has a specific definition now:

‘Substantial modification’ means any change to any aspect of the clinical trial […] which is likely to have a substantial impact on the safety or rights of the subjects or on the reliability and robustness of the data generated in the clinical trial;

However, the dictionary definition of amendment actually refers to a change in a written text (e.g., the protocol or informed consent), whereas modification refers here to a change in the clinical trial itself and the new procedure for authorising such modifications.

Therefore, we should add substantial modification to our termbases, but not necessarily replace the use of substantial amendment. In practice, I suspect that amendment will continue to be widely used in the context of protocols and informed consents.

Spanish: amendment and modification are both translated as modificación in the old and new legislation alike. However, in practice, enmienda is often used for amendment in clinical trial documentation."

https://signsandsymptomsoftranslation.com/2015/12/16/ct-reg-...

--------------------------------------------------
Note added at 13 mins (2018-11-13 19:00:25 GMT)
--------------------------------------------------

http://www.trilogywriting.com/glossary/substantial-modificat...
Substantial modification of a clinical trial. Any change to any aspect of a clinical trial made after notification of approval of a clinical trial, which is likely to have a ...

https://ec.europa.eu/health/sites/health/files/files/eudrale...
Question: How is a "substantial modification" defined?
74.
Answer:
Article 2(2)(13) of The Clinical Trials Regulation defines a
substantial modification as "any change to any aspect of the clinical trial which is made AFTER notification of a decision referred to in articles 8, 14, 19, 20 or 23 and which is likely to have a substantial impact on the safety or rights of the subjects or on the reliability and robustness of the data generated in the clinical trial".
This implies that a substantial modification (SM) can be submitted
and assessed only after a decision is issued on a previously submitted
application: initial application (article 8), additional member state (article 14), another SM on Part I only or Part II only or both
Part I and II (articles 19, 20 and 23) (see also Q2.2).
Selected response from:

Neil Ashby
Spain
Local time: 02:58
Grading comment
thx
4 KudoZ points were awarded for this answer



Summary of answers provided
4 +6substantial modification/amendment
Neil Ashby


  

Answers


8 mins   confidence: Answerer confidence 4/5Answerer confidence 4/5 peer agreement (net): +6
substantial modification/amendment


Explanation:
I think the difference depends on whether the text of the clinical trial protocol is changed (amendment), or the actual protocol is changed (modification).
See Emma Goldsmith's piece on it here:

"Substantial amendment/substantial modification: the same or different?

On the surface, the term modification appears to have replaced amendment in the new Regulation. Substantial modification even has a specific definition now:

‘Substantial modification’ means any change to any aspect of the clinical trial […] which is likely to have a substantial impact on the safety or rights of the subjects or on the reliability and robustness of the data generated in the clinical trial;

However, the dictionary definition of amendment actually refers to a change in a written text (e.g., the protocol or informed consent), whereas modification refers here to a change in the clinical trial itself and the new procedure for authorising such modifications.

Therefore, we should add substantial modification to our termbases, but not necessarily replace the use of substantial amendment. In practice, I suspect that amendment will continue to be widely used in the context of protocols and informed consents.

Spanish: amendment and modification are both translated as modificación in the old and new legislation alike. However, in practice, enmienda is often used for amendment in clinical trial documentation."

https://signsandsymptomsoftranslation.com/2015/12/16/ct-reg-...

--------------------------------------------------
Note added at 13 mins (2018-11-13 19:00:25 GMT)
--------------------------------------------------

http://www.trilogywriting.com/glossary/substantial-modificat...
Substantial modification of a clinical trial. Any change to any aspect of a clinical trial made after notification of approval of a clinical trial, which is likely to have a ...

https://ec.europa.eu/health/sites/health/files/files/eudrale...
Question: How is a "substantial modification" defined?
74.
Answer:
Article 2(2)(13) of The Clinical Trials Regulation defines a
substantial modification as "any change to any aspect of the clinical trial which is made AFTER notification of a decision referred to in articles 8, 14, 19, 20 or 23 and which is likely to have a substantial impact on the safety or rights of the subjects or on the reliability and robustness of the data generated in the clinical trial".
This implies that a substantial modification (SM) can be submitted
and assessed only after a decision is issued on a previously submitted
application: initial application (article 8), additional member state (article 14), another SM on Part I only or Part II only or both
Part I and II (articles 19, 20 and 23) (see also Q2.2).


Neil Ashby
Spain
Local time: 02:58
Specializes in field
Native speaker of: Native in EnglishEnglish
PRO pts in category: 302
Grading comment
thx

Peer comments on this answer (and responses from the answerer)
agree  Maria Iglesia Ramos: exactly
21 mins
  -> Thanks María

agree  spanruss: "Substantial amendment" is standard for clinical trial documentation.
1 hr
  -> Thanks, but check out the 1st and 3rd refs, it's not always "amendment"; I don't think it's 100% clear from the context provided, no?

agree  Heather Oland: I've used "substantial amendment" in this context per client request.
3 hrs
  -> Thanks, but check out the 1st and 3rd refs, it's not always "amendment"; I don't think it's 100% clear from the context provided, no?

agree  Carlos Teran
5 hrs
  -> Gracias Carlos

agree  Chema Nieto Castañón
13 hrs
  -> Gracias Chema

agree  Amy Gulvin
2 days 3 hrs
  -> Thanks Amy
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