Course Summary

A clinical trial, particularly a late-phase commercial study, is a major project requiring collaboration between the sponsor and staff or contractor, on the one hand, and the clinical investigator(s) and other healthcare professionals on the other. Good communication among all parties is essential. In this short course we introduce the major roles in a typical clinical research project and outline their duties.

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 the major roles in a typical clinical research project
• Outline the duties of sponsor, investigator, monitor, project manager and study nurse
• Define contract research organisation

Module Outline

Key topics covered in this module include:

• validity;
• bias;
• randomised controlled trials;
• trial design;
• placebo considerations;
• comparator-controlled studies;
• parallel versus crossover design.

Assessment - Multiple-choice assessment.