Glossary entry (derived from question below)
Spanish term or phrase:
no post autorización
English translation:
(observational epidemiological study) not meeting the characteristics of a post-authorisation study
Added to glossary by
Charles Davis
Jun 30, 2017 09:06
6 yrs ago
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Spanish term
Netherlands
Broad medical experience
Native in: English (Variants: US, UK) 
Works in: Spanish to English, Portuguese to English
no post autorización
Spanish to English
Medical
Medical: Pharmaceuticals
Clinical trials
Solicitud de Evaluación de Estudio Observacional no post autorización
Siguiendo vuestro procedimiento, encontrarán adjunta la siguiente Documentación requerida para su evaluación:
Carta-solicitud de evaluación de estudio con referencia ALX-HPP-501 Registry
Clasificación por parte de la AEMPS
Compromiso de investigadores participantes.
Solicitud de evaluación, según modelo específico de Euskadi
Compromiso de publicación de los resultados del estudio
Memoria económica del estudio V1.0 24Sep2013
Protocolo completo v1.1, 06Oct2014
Cuaderno de recogida de datos v.
This is the subject line of an application to conduct a clinical study. I have not heard of a Nonpost-authorization Observational Study, but maybe I am missing something. Thoughts?
TIA,
Juliette
Siguiendo vuestro procedimiento, encontrarán adjunta la siguiente Documentación requerida para su evaluación:
Carta-solicitud de evaluación de estudio con referencia ALX-HPP-501 Registry
Clasificación por parte de la AEMPS
Compromiso de investigadores participantes.
Solicitud de evaluación, según modelo específico de Euskadi
Compromiso de publicación de los resultados del estudio
Memoria económica del estudio V1.0 24Sep2013
Protocolo completo v1.1, 06Oct2014
Cuaderno de recogida de datos v.
This is the subject line of an application to conduct a clinical study. I have not heard of a Nonpost-authorization Observational Study, but maybe I am missing something. Thoughts?
TIA,
Juliette
Proposed translations
(English)
| 4 +1 | (observational epidemiological study) not meeting the characteristics of a post-authorisation study |
Charles Davis
|
Change log
Jul 25, 2017 21:18: Charles Davis Created KOG entry
Proposed translations
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Selected
(observational epidemiological study) not meeting the characteristics of a post-authorisation study
Sorry this is such a mouthful, but I don't think we have an expression for this.
It's not a typo; it's a well established term. Here's one among many explanations available online:
"No-EPA – Estudio observacional no post-autorización
También conocidos como estudios epidemiológicos, en ellos el medicamento no es factor de exposición fundamental investigado. Son de carácter descriptivo, y miden a la vez la prevalencia de la exposición y del efecto en una muestra poblacional en un periodo concreto en el tiempo, permitiendo estimar la magnitud y distribución de una enfermedad o condición en un momento dado."
http://leonresearch.com/blog/tipos-de-estudios-observacional...
PAS (post-authorisation studies), subdivided into PASS (safety) and PAES (efficacy), is of course standard, but we just don't talk about non-PAS, as far as I can tell. And we can't just call these epidemiological studies. They are defined negatively; they are observational epidemiological studies that are not EPA (PAS).
I've taken my answer from this site, which as far as I can see is very well written and authoritative:
"B.2) STUDIES PREVIOUSLY APPROVED BY OTHER ACCREDITED ETHICS COMMITTEES
Favorable rulings handed down by any accredited ethics committee in our country regarding a post-authorization study or an epidemiological study not meeting the characteristics of a post authorization study shall be recognized by health authorities or publicly funded bodies, hospital management, and the hospital's ethics committee; no additional rulings will be required with regard to the ethical aspects of studies previously evaluated by other ethics committees."
It also offers clear explanations of the various types of EPA (PAS) in Spain.
http://www.fjd.es/iis_fjd/en/clinical-trials-committee/docum...
It's not a typo; it's a well established term. Here's one among many explanations available online:
"No-EPA – Estudio observacional no post-autorización
También conocidos como estudios epidemiológicos, en ellos el medicamento no es factor de exposición fundamental investigado. Son de carácter descriptivo, y miden a la vez la prevalencia de la exposición y del efecto en una muestra poblacional en un periodo concreto en el tiempo, permitiendo estimar la magnitud y distribución de una enfermedad o condición en un momento dado."
http://leonresearch.com/blog/tipos-de-estudios-observacional...
PAS (post-authorisation studies), subdivided into PASS (safety) and PAES (efficacy), is of course standard, but we just don't talk about non-PAS, as far as I can tell. And we can't just call these epidemiological studies. They are defined negatively; they are observational epidemiological studies that are not EPA (PAS).
I've taken my answer from this site, which as far as I can see is very well written and authoritative:
"B.2) STUDIES PREVIOUSLY APPROVED BY OTHER ACCREDITED ETHICS COMMITTEES
Favorable rulings handed down by any accredited ethics committee in our country regarding a post-authorization study or an epidemiological study not meeting the characteristics of a post authorization study shall be recognized by health authorities or publicly funded bodies, hospital management, and the hospital's ethics committee; no additional rulings will be required with regard to the ethical aspects of studies previously evaluated by other ethics committees."
It also offers clear explanations of the various types of EPA (PAS) in Spain.
http://www.fjd.es/iis_fjd/en/clinical-trials-committee/docum...
4 KudoZ points awarded for this answer.
Comment: "Thank you!"
Reference comments
49 mins
Reference:
see
http://www.elsevier.es/es-revista-medicina-clinica-2-articul...
Otro tipo de estudios son los estudios observacionales no EPA, definidos como aquéllos en los que el factor de exposición fundamental investigado no es un medicamento.
estudios postautorización (EPA)
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Note added at 57 mins (2017-06-30 10:04:05 GMT)
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https://inforeuma.com/wp-content/uploads/2015/09/Faq3.pdf
En relación a su consulta sobre los requisitos que debe cumplir el Consentimiento Informado del estudio “Proyecto CarMa”, así como qué CEIC es el competente para evaluarle y emitir el dictamen pertinente, le informo de lo siguiente: Tal y como me indica a través de correo electrónico, remitido el día 5 de mayo de 2010, se trata de un estudio observacional no considerado posautorización, denominado No-EPA. Los estudios observacionales No-EPA son aquellos en los que el factor de exposición fundamental investigado no son medicamentos, aunque curiosamente vienen regulados en la Orden SAS/3470/2009, de 16 de diciembre, por la que se publican las directrices sobre estudios posautorización de tipo observacional para medicamentos de uso humano.
Otro tipo de estudios son los estudios observacionales no EPA, definidos como aquéllos en los que el factor de exposición fundamental investigado no es un medicamento.
estudios postautorización (EPA)
--------------------------------------------------
Note added at 57 mins (2017-06-30 10:04:05 GMT)
--------------------------------------------------
https://inforeuma.com/wp-content/uploads/2015/09/Faq3.pdf
En relación a su consulta sobre los requisitos que debe cumplir el Consentimiento Informado del estudio “Proyecto CarMa”, así como qué CEIC es el competente para evaluarle y emitir el dictamen pertinente, le informo de lo siguiente: Tal y como me indica a través de correo electrónico, remitido el día 5 de mayo de 2010, se trata de un estudio observacional no considerado posautorización, denominado No-EPA. Los estudios observacionales No-EPA son aquellos en los que el factor de exposición fundamental investigado no son medicamentos, aunque curiosamente vienen regulados en la Orden SAS/3470/2009, de 16 de diciembre, por la que se publican las directrices sobre estudios posautorización de tipo observacional para medicamentos de uso humano.
1 hr
Reference:
The study in question--no drugs are administered
http://www.hra.nhs.uk/news/research-summaries/alx-hpp-501-v1...
Research summary We are conducting this study to learn about patients who have Hypophosphatasia (HPP). HPP is an ultra-rare bone disorder caused by gene mutations or changes. These gene mutations result in low or absent levels of an enzyme needed to harden bones. There is no approved treatment for this condition. Due to the rare nature of this disease, and considering the lack of information regarding diagnosis and health care management in a “real world” setting, this study will document the demography, clinical course, and impact of disease on patients of all ages who have HPP. There is no study drug administered in this study, patients who consent to participate will be asked to complete questionnaires at various timepoints, in line with routine clinic visits. We will be collecting data on the routine clinical care of patients of all ages, regardless of the age of onset of HPP, by reviewing patient medical records. There are no protocol specific clinical procedures to be undertaken. We plan to enroll at least 500 patients to better understand the disease. The expected duration of the study is at least 5 years.
Research summary We are conducting this study to learn about patients who have Hypophosphatasia (HPP). HPP is an ultra-rare bone disorder caused by gene mutations or changes. These gene mutations result in low or absent levels of an enzyme needed to harden bones. There is no approved treatment for this condition. Due to the rare nature of this disease, and considering the lack of information regarding diagnosis and health care management in a “real world” setting, this study will document the demography, clinical course, and impact of disease on patients of all ages who have HPP. There is no study drug administered in this study, patients who consent to participate will be asked to complete questionnaires at various timepoints, in line with routine clinic visits. We will be collecting data on the routine clinical care of patients of all ages, regardless of the age of onset of HPP, by reviewing patient medical records. There are no protocol specific clinical procedures to be undertaken. We plan to enroll at least 500 patients to better understand the disease. The expected duration of the study is at least 5 years.
Discussion
https://clinicaltrials.gov/ct2/show/NCT02306720
or has lost a word as in non-interventional post-marketing studies