Course Summary

Clinical trial protocols are an essential part of clinical trial design. Protocol documents are critical to conducting safe and cost-effective investigations. Protocol documents are large and complex, containing comprehensive information relating to purpose, design and conduct of a clinical trial. Aspects of a protocol include patient eligibility criteria, and treatment specifications. This short course provides an overview of clinical trial protocols. Opportunities to improve a clinical trial protocol for regulatory approval are also discussed.

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

• Identify the regulatory requirements to complete a protocol for submission to the regulatory authorities
• Explain the importance of the informed consent form addressed in the clinical trial protocol
• Describe the main features of a clinical trial protocol
• Outline opportunities to improve a clinical trial protocol for regulatory submission

Module Outline

Key topics covered in this module include:

• Regulatory and ethical considerations;
• Study objectives;
• Eligibility criteria;
• Treatment specifications;
• Safety monitoring;
• Statistics and data management; and
• Opportunities to improve the protocol.

Assessment - Multiple-choice assessment.