Anatomy of a Clinical Trial

• Understand and explain at an overview level the stages of a clinical trial
• Describe the roles and responsibilities of the clinical trial team
• Explain the key steps involved in planning, designing and conducting clinical trials
• List the types of documentation in a clinical trial and describe the case reporting form and trial protocol
• Explain data management in a clinical trial

Learner Benefits:

• In-Depth Understanding of Clinical Trial Phases: Gain a clear grasp of the stages of a clinical trial—planning, conducting, and closeout—helping you manage trials effectively and ensure they meet regulatory standards.

• Clarity on Roles and Responsibilities within the Clinical Team: Learn the distinct roles of key team members (e.g., clinicians, biostatisticians, safety representatives) and how they collaborate to ensure successful trial execution.

• Familiarity with ICH GCP Guidelines: Strengthen your knowledge of Good Clinical Practice, ensuring that you can navigate compliance requirements and uphold high ethical and safety standards in clinical research.

• Expertise in Clinical Trial Documentation: Understand the critical documents involved, such as the clinical trial protocol and case report forms (CRFs), and how they support trial design, data collection, and regulatory submissions.

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