certificato GCP

standard di GCP

GCP di serie («Good Clinical Practice», Buona Pratica Clinica , GOST R 52379-2005) - lo standard internazionale di etica e la qualità della ricerca, che descrive le regole di progettazione, di, tenuta dei registri e reporting sulla ricerca, che implicano la partecipazione umana come Leggi di più…

Di NBScience, fa
ricerca clinica

Buona Pratica Clinica

Buona Pratica Clinica

Descrizione: 
The tripartite harmonised ICH Guideline was finalised under Passo 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.
Implementation
Passo 5
Stati Uniti:
Adopted by CPMP, luglio 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 Maggio 1997, vol. 62, No. 90, p. 25691-25709
(more…)

Di NBScience, fa
terapia con cellule staminali