Sponsor-Investigators Frequently Cited in FDA Warning Letters. Do You Know What Is Required for a High Quality Trial?

8/17/2021

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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?

FDA warning letters frequently address issues with sponsor-investigator led clinical trials. This is likely due to the fact that they are used to being an investigator but are not as familiar with sponsor regulatory responsibilities. In this warning letter from 2020 for a significant medical device risk clinical trial, the sponsor-investigator failed to:

  • ensure the clinical trial was properly monitored

  • obtain IRB approval and review

  • submit progress reports to the IRB and FDA

  • maintain records of device receipt, use, or disposition

Adequate knowledge and training in advance of beginning a clinical trial would reduce the rate of violations, reduce risk to subjects, and increase the quality of and confidence in the data.

 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.

 

IIT training can be purchased as a single license for limited individual use, as a SCORM package for use in your LMS, or can be fully customized to your organization's requirements. No LMS? We can host this course or a full curriculum to train your teams or site staff. Contact us at info@clinicalpathwaysresearch.com for more information.

 

- The Clinical Pathways Team

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