Course Summary

The demands on quality from clinical trials are increasing. Quantitative aspects of clinical trials, such as the mass of study data to be collected, the multiple investigational sites, and the need to meet predetermined timelines, often supersede qualitative features. Therefore, addressing basic requirements for quality management is essential when preparing a clinical trial. This short course describes the core elements required for the establishment of a clinical trial and provides an overview of the role of the sponsor in supporting and improving trial quality.

Who will benefit from this module?

This module is intended for all those involved in the preparation, design, conduct or analysis of clinical trials. It will be useful to new entrants to the field or as a refresher for staff, including clinical research associates and data managers, in the clinical/medical departments of pharmaceutical or biotechnology companies or in contract research organisations. It will also be of interest to clinical investigators, study coordinators, and other healthcare staff working on clinical trials.ntract research organisations. It will also be of interest to clinical investigators, study coordinators, and other healthcare staff working on clinical trials.

Learning Objectives

• Identify essential documents that research ethics committees and regulatory authorities will evaluate in deciding whether to approve a clinical trial
• Define the key roles of personnel involved in conducting and monitoring clinical investigations
• Identify the responsibilities of sponsors in ensuring high quality clinical trials
• Describe the core preparatory elements necessary to conduct a successful clinical trial

Module Outline

Key topics covered in this module include:

• Essential documents
• Clinical trial management
• Feasibility studies
• Multicentre trials
• Enrolment strategies and contingency plans
• Communication tools
• Quality control

Assessment - Multiple-choice assessment.