Introduction To Clinical Trials & Clinical Trials Practice

Hosted at: The Institute of Clinical Research Training Suite

Starts On: October 01, 2019

Finishes: October 03, 2019


CPD Points

The Course

This course is now fully booked.

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

Course Documentation

We are unable to provide online booking to this course at the moment, if you need to attend this course please contact us at:

Tel: 01628 501701, Email: [email protected]

We have a similar upcoming course on the January 28, 2020, please click here for more details.