10/29/2019

What are investigator initiated trials, and are they truly initiated by investigators, or by industry sponsors? Investigators may have an idea for a clinical trial with an investigational or approved product. Such trials can help answer important questions about medical products and devices. When investigators initiate the clinical trial, they also must fill the role of a sponsor. A sponsor-investigator conducted clinical trial is also known as an investigator initiated trial. From the regulatory side, there is not a lot of guidance on such trials, but there is a focus on them for inspections. The sponsor-investigator is ultimately responsible for the regulations that are applicable for sponsors AND investigators. Do you know which regulations and guidelines are applicable and that they have different definitions?

Understanding the importance of clearly identifying roles and ensuring clear expectations can support a successful trial outcome. Our interactive eLearning course offers:

Knowledge Checks
Post Assessment
Scenarios to apply your knowledge
Certificate of Completion

To sample an interactive demo or to purchase the full course, visit our store here.

- The Clinical Pathways Team

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