Your browser doesn't support javascript.
loading
Mostrar: 20 | 50 | 100
Resultados 1 - 5 de 5
Filtrar
Mais filtros










Base de dados
Intervalo de ano de publicação
1.
Therapie ; 78(5S): S11-S18, 2023.
Artigo em Francês | MEDLINE | ID: mdl-27839710

RESUMO

CONTEXT: Clinical studies involve an increasing amount of data collection and management. However, there is no specific quality standard sufficiently practical, in free access, and open for data management and the underlying IT-infrastructure in academic units. European Clinical Research Infrastructures Network (ECRIN) published standard requirements for certified data management units. We present a French version of these standards. METHODS: A group of experts produced the standards, by consensus. The first version was revised after two pilot audits for data centre certification were performed. RESULTS: The revised version includes 21 lists of five to ten standards, in three groups: information technologies, data management (DM) and "general". CONCLUSIONS: These standards offer a clear description of DM and IT requirements for clinical studies. Initially created for ECRIN certification purposes, they offer a very useful reference for academic DM structures.

2.
Therapie ; 72(5): 525-538, 2017 Oct.
Artigo em Francês | MEDLINE | ID: mdl-28389014

RESUMO

French clinical investigation centers (CICs) are academic platforms dedicated to clinical research. The QUALI-CIC working group helps to improve and harmonize practices within the CIC network. After some years of implementation, the manual of good professional practices of CICs (MGPP CIC) completed in 2010, needed to be revised to best fit with the large panel of CIC activities. The aim was also to make it more accurate and to reinforce requirements about participants safety and data security. In its second version published in the present article, the MGPP CIC includes 255 items divided into 15 chapters. An explanatory document, currently being drafted, will complete the manual to facilitate its implementation.


Assuntos
Centros Médicos Acadêmicos , Pesquisa Biomédica/normas , Manuais como Assunto , Garantia da Qualidade dos Cuidados de Saúde , França , Humanos
3.
Therapie ; 68(3): 135-41, 2013.
Artigo em Francês | MEDLINE | ID: mdl-23886457

RESUMO

OBJECTIVE: Sponsors must take responsibility for the quality of trials at the best possible cost. Our objective was to describe the most frequent quality failures, how they impact trial results, and identify the most efficient monitoring strategies using published articles and reports. RESULTS: Errors affecting clinical trials include conception, procedures, data management, and data analysis. The consequences are usually an overestimation of the treatment effect. No study shows that monitoring reduces the risk of errors, and there is no comparison of monitoring methods. Many research organisations advocate for monitoring based on risk analysis and recommend an extensive use of centralised monitoring. CONCLUSIONS: Trial quality depends on trial conception and design. Study conduct should guarantee a maximum level of quality level. This should be done using risk management and extensive centralised monitoring.


Assuntos
Ensaios Clínicos como Assunto/métodos , Comitês de Monitoramento de Dados de Ensaios Clínicos , Ensaios Clínicos como Assunto/normas , Interpretação Estatística de Dados , Determinação de Ponto Final , Humanos , Controle de Qualidade , Indicadores de Qualidade em Assistência à Saúde , Projetos de Pesquisa , Gestão de Riscos
4.
Therapie ; 67(1): 11-42, 2012.
Artigo em Francês | MEDLINE | ID: mdl-22487500

RESUMO

Clinical Investigation Centres (CICs) are academic organisations for performing clinical studies. They are a part of a national network which is co-ordinated by French national institute for health and medical research (Inserm), and the head office of healthcare provision (DGOS). There are working groups and specialised networks within the overall CIC network. The Harmonisation of CIC Procedures (HPCIC) group wrote a manual of good professional practices for clinical research. This manual is described here. This manual was written by consensus. It was approved by the coordinators of all CICs, external experts, and validated by representatives of both Inserm and the General directorate of healthcare provision (DGOS). The CIC Good Professional Practices manual is a guide divided into two sections. The first section covers the general management of a CIC (common to all CICs). The second section covers the core activities of CICs, running clinical studies (clinical study coordination, clinical investigation, data management, statistical analysis, valorisation). This manual is available for all CICs and any other clinical research organisations. It will serve as a basis for CIC self-quality evaluation, audits between CICs, and external audits. This manual shows how much the CICs want to standardise practices and procedures nationwide to offer their partners the best quality in performing clinical studies.


Assuntos
Pesquisa Biomédica/normas , Pesquisa Biomédica/organização & administração , França , Guias como Assunto , Humanos , Auditoria Administrativa , Reprodutibilidade dos Testes
5.
Therapie ; 67(1): 11-42, 2012.
Artigo em Francês | MEDLINE | ID: mdl-27393657

RESUMO

Clinical Investigation Centres (CICs) are academic organisations for performing clinical studies. They are a part of a national network which is co-ordinated by French national institute for health and medical research (Inserm), and the head office of healthcare provision (DGOS). There are working groups and specialised networks within the overall CIC network. The Harmonisation of CIC Procedures (HPCIC) group wrote a manual of good professional practices for clinical research. This manual is described here. This manual was written by consensus. It was approved by the coordinators of all CICs, external experts, and validated by representatives of both Inserm and the General directorate of healthcare provision (DGOS). The CIC Good Professional Practices manual is a guide divided into two sections. The first section covers the general management of a CIC (common to all CICs). The second section covers the core activities of CICs, running clinical studies (clinical study coordination, clinical investigation, data management, statistical analysis, valorisation). This manual is available for all CICs and any other clinical research organisations. It will serve as a basis for CIC self-quality evaluation, audits between CICs, and external audits. This manual shows how much the CICs want to standardise practices and procedures nationwide to offer their partners the best quality in performing clinical studies.

SELEÇÃO DE REFERÊNCIAS
DETALHE DA PESQUISA
...