Module 01:

• Overview
• Introduction
• Pages
  • Page 01
  • Page 02
  • Page 03
  • Page 04
  • Page 05
  • Page 06
  • Page 07
  • Page 08
  • Page 09
  • Page 10
• Assessment
• Questions
  • Question 01
  • Question 02
  • Question 03
  • Question 04
  • Question 05
  • Question 06
  • Question 07
• Key Points / Summary
• Further Reading / Resources

Course Introduction

Introduction

Good Clinical Practice and the UK Law

This Module will focus on the following:

• The history and background of the United Kingdom Statutory Instruments (UKSIs)
• Understanding the legal framework for Good Clinical Practice application and enforcement in the UK and the role of the Medicines and Healthcare Products Regulatory Agency (MHRA)
• Consequences of failure to comply with the UKSIs

This Module uses the following abbreviations:

• MHRA - The Medicines and Healthcare products Regulatory Agency
• UKSI 1031 - The Medicines for Human Use (Clinical Trials) Regulations 2004 (UKSI 2004 No. 1031)
• UKSI 1928 - The Medicines for Human Use (Clinical Trials) Amendment Regulations 2006 (UKSI 2006 No. 1928)