clinical research

Пример тестовых заданий для оформления сертификата GCP в 2018-2020 году

Пример тестовых заданий для оформления сертификата GCP в 2018-2020 году   1) При использовании перекресного дизайна при исследованиях биоэквивалентности:   a) пациентам группы назначается одинаковое лечение.   b) пациенты, при помощи процедуры рандомизации, распределяются на Read more…

By NBScience, ago
clinical research

Good Clinical Practice

Good Clinical Practice

Description: 
The tripartite harmonised ICH Guideline was finalised under Step 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
EU:
Adopted by CPMP, July 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 May 1997, Vol. 62, No. 90, p. 25691-25709
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By NBScience, ago
Auditor GCP

Auditor, GCP

Auditor, 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 Read more…

By NBScience, ago
Auditor 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 Read more…

By NBScience, ago
stem cell therapy