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CT03: ICH Good Clinical Practice

CT03: ICH Good Clinical Practice

  • 30 Day Money Back Guarantee
  • Completion Certificate
  • 24/7 Technical Support

Highlights

  • On-Demand course

  • 3 hours

  • Beginner level

Description

Good Clinical Practice (GCP) is a set of internationally recognised ethical and scientific quality requirements for designing, conducting, recording and reporting clinical trials. Compliance with GCP principles is required by regulatory authorities in many countries for the authorisation of clinical trials and the acceptance of their data. The International Council for Harmonisation’s guideline E6, often referred to as ICH GCP, is the international standard specification for Good Clinical Practice.

This module introduces GCP and sets it in the context of typical collaborative work in clinical research. We discuss the role and goals of the International Council for Harmonisation and the principles of GCP. We describe the roles of members of a team working on a clinical trial. We set out the documentation that must be created and maintained. We specify the responsibilities of trial sponsors, clinical investigators and monitors. We explain the rationale and execution of the informed consent process, and discuss issues that arise in practice.

The module is fully up to date with Revision 2 of ICH GCP.

This training meets the minimum criteria for ICH GCP investigator site personnel training identified by TransCelerate BioPharma, Inc. as necessary to enable mutual recognition of GCP training among trial sponsors.

Course Content

  1. CT03: ICH Good Clinical Practice

About The Provider

Zenosis
Zenosis
Dundee
We specialise in Pharmaceutical & Biotech courses for healthcare professionals, as well as a suite of essential courses for regulatory and statutory business compliance. As a member of the CPD, you can be assured that our courses meet exacting standards and deliver a compelli...
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