Course Summary

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 in applications for marketing approval. The International Council for Harmonisation’s guideline E6, often referred to as ICH GCP, is the international standard specification for Good Clinical Practice. In this short course we describe the ICH’s role in the harmonisation of regulations, introduce its guideline E6, and set out the principles of GCP.

Who will benefit from this module?

This course provides essential learning for clinical research associates, project managers and other employees of companies sponsoring clinical research, as well as all healthcare professionals involved in conducting clinical trials. Anyone who needs to develop an understanding of the importance of Good Clinical Practice and its application should take this course.

Learning Objectives

• Identify factors motivating demand for harmonisation of regulations for the drug industry and clinical research
• Specify categories of guidelines developed by the ICH
• Define ICH GCP and state its aims and applicability
• Specify principles of GCP
• Summarise the role of an Institutional Review Board or Independent Ethics Committee in overseeing clinical research

Module Outline

Key topics covered in this module include:

• International harmonisation of regulatory requirements
• ICH guideline on Good Clinical Practice
• ICH GCP principles
• Institutional Review Board / Independent Ethics Committee

Assessment - Multiple-choice assessment.