Course Summary

Capture and management of clinical trial data is a challenge. The industry is under pressure to obtain and analyse such data more quickly, while maintaining data integrity, so that products can be brought to market sooner. Effective planning and adequate resources can ensure clinical trials yield high quality data within strict timelines and budget requirements, at the same time satisfying regulatory standards. This short course describes the purpose of data capture and explores efficiencies in data management as part of the evolving regulatory landscape.

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.

Learning Objectives

• Describe the purpose of data capture and management
• Outline the regulatory requirements for clinical data capture and management
• Describe how electronic data capture can improve data quality and shorten trial timelines

Module Outline

Key topics covered in this module include:

• data capture
• data management
• design of case report forms
• electronic data capture
• Decentralised clinical trials

Assessment - Multiple-choice assessment.