klinik araştırma

İyi Klinik Uygulama

İyi Klinik Uygulama

Açıklama: 
The tripartite harmonised ICH Guideline was finalised under Adım 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
Adım 5
ben:
Adopted by CPMP, Temmuz 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 Mayıs 1997, Cilt. 62, Hayır. 90, p. 25691-25709
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Denetçi GSİO

Denetçi, GSO

Denetçi, GCP Responsibilities The GCP Auditor is responsible for quality assurance auditing of all activities subject to the, “ICH Good Clinical Practice: Consolidated Guideline,” (GCPs), supporting a program of quality assurance (QA) to ensure that Daha fazla oku…

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Denetçi GSİO

Director, GSO

Responsibilities The Director, GCP will be required to oversee all and participate in, quality assurance auditing of all activities subject to the, “ICH Good Clinical/Laboratory Practice: Consolidated Guideline,” (GCP/GLP’s), supporting a program of quality assurance Daha fazla oku…

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