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28-Jan-2020 - 30-Jan-2020

J2 Introduction to Clinical Trials and Clinical Trials Practice

  • Location:
    • Cedar Court
    • White Waltham
    • Maidenhead, Berkshire
    • SL6 3LW
    • England
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The Course

An Introduction to Clinical Trials and Clinical Trial Practice, the ICR’s flagship training course, is accredited by Cranfield University. This highly practical course explores the relevance of clinical research in drug development and summarises the ethical and regulatory requirements for clinical trials. It covers clinical trial methodology and summarises the principles of Good Clinical Practice. The course gives an overview of the various aspects of clinical research and will be of interest to all members of the clinical study team. It uses a combination of lectures, tutorials and group workshops. Delegates receive a comprehensive workbook and a copy of ICH GCP guidelines. The content of the course will equip delegates to sit the ICR Certificate examination.

Learning Objectives

  • Relate the relevance of clinical trials to the drug development process
  • Design a simple protocol and draft appropriate case record forms
  • Demonstrate the basic principles behind the statistical sections of a protocol
  • Summarise the ethical and regulatory requirements that must be met before a clinical trial commences
  • Describe the requirements for conducting monitoring visits
  • Determine the difference between an adverse event and an adverse drug reaction
  • Outline the audit process and how it fits into the quality system
  • Compare the differences between drug and device trials

Course Outline

  • Introduction to GCP
  • Drug development process
  • EU Directives
  • Basic principles of statistics for CRA's
  • Clinical trial & design workshop
  • Phase 1 studies
  • Designing simple protocols
  • Case Report Form (CRF) design
  • Pre trial organisation
  • Ethics Committees approval
  • Clinical trial applications
  • Patient information sheets & informed consent
  • Clinical trial monitoring visits
  • Source data verification
  • Pharmacovigilance, AEs & ADRs
  • Quality assurance
  • Marketing authorisation