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A UL course

This course covers the process of developing a research protocol for human investigation and testing for medications that are not sold or available in the United States. This process requires recruiting and enrolling people to participate as volunteers in an investigational study for a new product not currently sold. In this course, such studies are referred to interchangeably as “clinical research trial” and “investigational study.” This course outlines the steps that must be taken by a sponsor of a new drug or product before it is available for sale. Discussions will include steps required for the investigational drug approval process and device clinical trials (device trials with human subjects).

Featured topics

  • Requirements for financial disclosure
  • Who is responsible for disclosing financial information
  • How FDA evaluates clinical investigators’ financial disclosures

Who should attend?

Professionals and experts in the pharmaceutical, biotechnology, and medical device fields

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