I gcp

I gcp

stem cell therapy in Ukraine

Buona pratica clinica

Buona pratica clinica

Description: 

The tripartite harmonised ICH Guideline was finalised underStep 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: 

Step 5

Unione Europea:

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

(altro…)

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stem cell therapy in Ukraine

Norma GCP

PCG standard («Good Clinical Practice», Buona pratica clinica , GOST R 52379-2005) — standard internazionale per gli standard etici e la qualità della ricerca scientifica, descrivere le regole di sviluppo, effettuando, mantenere la documentazione e la rendicontazione della ricerca, che implicano la partecipazione umana come soggetto di prova (studi clinici). La conformità di uno studio a questo standard indica la conformità del pubblico: прав участников исследования правил Leggi tutto

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stem cell therapy in Ukraine

Associato di ricerca clinica/Coordinatore della ricerca clinica

Responsibilities The CRA/CRC is responsible for the monitoring or auditing of all activities subject to the, “ICH Good Clinical Practice: Consolidated Guideline,” (GCP), supporting client programs administrated by Watermark ensure project data and summary statements are of known and documented quality. Requirements Will be expected to travel extensively to study Leggi tutto

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