New clinical trials regulation in Spain: analysis of royal decree 1090/2015
Clin. transl. oncol. (Print)
; 19(3): 291-300, mar. 2017. graf
Artigo
em Inglês
| IBECS
| ID: ibc-160185
Biblioteca responsável:
ES1.1
Localização: BNCS
ABSTRACT
The coming into force of Directive 2001/20/EC represented a step forward in harmonising clinical trial regulation in European countries, guaranteeing a uniform protection of subjects participating in clinical research across Europe. However, it led to a disproportionate increase in the bureaucratization, and thus, it became evident that procedures needed to be simplified without detriment to patients safety. Thus, Regulation 536/2014, that repealed Directive 2001/20/EC, with the aim of decreasing the growing bureaucratization and stimulating clinical research in Europe, established simplified procedures, such as regulating a common procedure for authorising trials in Europe, the institution of strict assessment timelines, or the definition of new concepts, such as «low-intervention clinical trial». The legal form of a Regulation allowed the norm to be directly applied to Member States without the need for transposition. By means of the new Royal Decree, the national legislation is adapted to make the application of the regulation feasible and it allows the development of the aspects that the Regulation leaves to national legislation. Both documents seek to stimulate clinical research with medicinal products to foster knowledge, facilitate transparency, and reinforce subjects safety. This will surely be the case, but with this revision, we will look at the novelties and key aspects that are most relevant to investigators and we will analyse the consequences for all parties involved in clinical research (AU)
RESUMEN
No disponible
Texto completo:
Disponível
Coleções:
Bases de dados nacionais
/
Espanha
Base de dados:
IBECS
Assunto principal:
Ensaios Clínicos como Assunto
/
Legislação Referente à Liberdade de Escolha do Paciente
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Intervenção Legal
/
Pesquisa Biomédica
/
Compensação e Reparação
/
51725
/
Estudos Controlados Antes e Depois
Tipo de estudo:
Ensaio clínico controlado
/
Guia de prática clínica
/
Estudo prognóstico
Limite:
Feminino
/
Humanos
/
Masculino
Idioma:
Inglês
Revista:
Clin. transl. oncol. (Print)
Ano de publicação:
2017
Tipo de documento:
Artigo
Instituição/País de afiliação:
Complejo Hospitalario Regional Virgen Macarena/Spain
/
Complejo Hospitalario Universitario de Vigo/Spain
/
Complejo Hospitalario de Navarra de Pamplona/Spain
/
Complexo Hospitalario Universitario A Coruña/Spain
/
Hospital 12 de Octubre/Spain
/
Hospital Clinic I Provincial/Spain
/
Hospital Clínico Universitario/Spain
/
Hospital Universitari i Politècnic la Fe/Spain
/
Hospital Universitario Gregorio Marañón/Spain
/
Hospital Universitario Virgen de las Nieves/Spain