[Organising an investigation site: a national training reference document]. / Organiser un site investigateur : un référentiel national de formation pédagogique.
Therapie
; 69(4): 367-81, 2014.
Article
en Fr
| MEDLINE
| ID: mdl-24998702
ABSTRACT
OBJECTIVE:
Several surveys have shown a declining performance of French investigators in conducting clinical trials. This is partly due to insufficient and heterogeneous investigator training and site organisation. A multidisciplinary group was set up to propose solutions. We describe the tools developed to improve study site organisation.RESULTS:
This working group was made up of clinical research experts from academia, industry, drug regulatory authorities, general practice, and consulting. Methods and tools were developed to improve site organisation.CONCLUSIONS:
The proposed tools mainly focus on increasing investigators' awareness of their responsibilities, their research environment, the importance of a thorough feasibility analysis, and the implementation of active patient recruitment strategies. These tools should be able to improve site organisation and performances in conducting clinical trials.
Texto completo:
1
Ejes tematicos:
Capacitacao_em_gestao_de_ciencia
/
Pesquisa_clinica
Banco de datos:
MEDLINE
Asunto principal:
Investigación Biomédica
Tipo de estudio:
Guideline
/
Prognostic_studies
Límite:
Humans
Idioma:
Fr
Año:
2014
Tipo del documento:
Article