Clinical Trial Protocol

Clinical research involving human participants is one of the most regulated areas in life sciences. Every successful clinical trial begins with a robust protocol that clearly defines objectives, methodology, and compliance requirements.

This course teaches you how to transform complex regulatory expectations into a clear, actionable clinical trial protocol under IND or IDE. You will learn how to structure your protocol effectively, avoid common pitfalls, manage amendments, and ensure full regulatory compliance, giving your study the best chance of IRB approval and successful execution.

Curriculum:

Who should enroll?
This course is designed for professionals involved in clinical research, protocol development, and trial management, including:

• Clinical Research Associates (CRAs) and Clinical Project Managers
• Investigators and study coordinators
• Regulatory Affairs specialists
• Quality Assurance and Compliance Officers
• Medical writers responsible for protocol documentation

 
What you’ll learn?
Through interactive lessons, case studies, and practical examples, participants will gain the skills to:

• Understand the purpose, structure, and critical components of a clinical trial protocol
• Draft compliant protocols that satisfy IND/IDE and IRB requirements
• Identify and avoid common errors in protocol design and writing
• Manage protocol amendments and updates effectively
• Apply data governance practices for both investigators and sponsors
• Improve overall trial quality and efficiency by integrating best practices in protocol development

By the end of this course, learners will be fully equipped to produce clear, compliant, and actionable clinical trial protocols that streamline IRB approvals, support better study outcomes, and maintain regulatory compliance throughout the trial lifecycle.
 
Introduction
 
Lesson 1: Introduction to Clinical Trial Protocol

• What is a Clinical Trial Protocol?
• Why is a Clinical Trial Protocol important?

 
Lesson 2: Content and Format of a Protocol

• Regulatory framework and ethical considerations of NIH in the EU and US

 
Lesson 3: Writing a Clinical Trial Protocol

• NIH’s protocol template

 
Lesson 4: Problems Encountered When Writing a Protocol

• Common problems in protocol development
• Errors to avoid during protocol development

 
Lesson 5: Making Amendments to a Clinical Trial Protocol

• What are amendments to a Clinical Trial Protocol?
• Process of making amendments
• Types of amendments

 
Conclusion
 
Quiz