Course Description

This web seminar will provide attendees with a general overview of oncology clinical trials and their distinct characteristics. We will review how oncology clinical trials differ from those in other therapeutic areas, with a special emphasis on the unique challenges of monitoring oncology clinical trials. Distinctions will be drawn between early and later phase trials. Attention will be paid to Adverse Event (AE) and Serious Adverse Event (SAE) reporting. All aspects of oncology clinical trials and how to successfully monitor them will also be discussed.

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Learning Objectives

• Identify the differences between monitoring oncology early phase clinical trials vs. later phase clinical trials
• Identify ways in which oncology clinical trials differ from those in other therapeutic areas
• Describe the complexities of AE and SAE monitoring in oncology clinical trials
• Utilize Common Terminology Criteria for Adverse Events (CTCAE) grading and apply CTCAE to AE source data
• Describe the common challenges in monitoring and apply tools and techniques to overcome them

Who Should Attend

• Monitors who are new to or are interested in learning more about oncology clinical trials

Instructor

Vanessa Laroche, B.S., CIP, CQA, C.C.R.P.