recherche clinique

Bonnes pratiques cliniques

Bonnes pratiques cliniques

La description: 
The tripartite harmonised ICH Guideline was finalised under Étape 4 in May 1996. This Good Clinical Practices document describes the responsibilities and expectations of all participants in the conduct of clinical trials, including investigators, monitors, sponsors and IRBs. GCPs cover aspects of monitoring, reporting and archiving of clinical trials and incorporating addenda on the Essential Documents and on the Investigator's Brochure which had been agreed earlier through the ICH process.
la mise en oeuvre: 
Étape 5
États-Unis:
Adopted by CPMP, juillet 1996, issued as CPMP/ICH/135/95/Step5, Explanatory Note and Comments to the above, issued as CPMP/768/97
MHLW:
Adopted March 1997, PAB Notification No. 430, MHLW Ordinance No. 28
FDA:
Published in the Federal Register, 9 Mai 1997, Vol. 62, Non. 90, p. 25691-25709
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certificat GCP

standard GCP

norme GCP («Les bonnes pratiques cliniques», Bonnes pratiques cliniques , GOST R 52379-2005) - la norme internationale de l'éthique et de la qualité de la recherche, décrivant les règles de conception, de, la tenue des dossiers et des rapports sur la recherche, qui impliquent la participation humaine Lire la suite…

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thérapie de cellules souches