Revisore GCP

Director, GCP

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 Per saperne di più…

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Пример тестовых заданий для оформления сертификата GCP в 2020-2021 году

Пример тестовых заданий для оформления сертификата GCP в 2020-2021 году 1) При использовании перекресного дизайна при исследованиях биоэквивалентности:   un) пациентам группы назначается одинаковое лечение.   B) пациенты, при помощи процедуры рандомизации, распределяются на Per saperne di più…

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Buona pratica clinica

Buona pratica clinica

Descrizione: 
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
ME:
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
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