2015, Number 2
Good Clinical Ptactice certification: the need to prepare the clinical sites and services involved in clinical trials to achieve this status
Méndez TR, Rodríguez RM, Botello RE
Full text
Language: Spanish
References: 3
Page: 57-60
PDF size: 67.76 Kb.
ABSTRACT
Certify compliance with Good Clinical Practice of one or more clinical sites and services that perform clinical trials (or both) should be the aspiration of health institutions linked to these investigations. This letter provides an approach to the certification process of Good Clinical Ptactice from the 52nd Regulation issued in 2008 by the Drug Regulatory Agency of Cuba, the Center for State Control of the Quality of Medicines, Equipment and Medical Devices, which establishes the requirements for clinical sites. The role of the National Clinical Trials Coordinating Center is specified in the diagnosis of compliance with the requirements of the "Manual of Methods for the preparation of clinical sites with a view to their certification in Good Clinical Practice" and an assessment is offered Provincial Clinical Trials Group of Villa Clara on the preparation of University Provincial Hospital " health institution with the greatest potential in the territory to face this process.REFERENCES