This course discussed the process of developing a research protocol for human investigation and testing for medications that are not sold or available on the market in the United States.  The phrase “clinical research” is a phrase specific to research involving human participation.  This process requires recruitment and enrollment of patient volunteers who will participate in an investigational study for a new product not currently sold.  The term “investigational study” will be used interchangeably with the phrase “clinical research trial.”  Likewise, and for the purpose of this course, the word “study” will be used interchangeably with “trial”.

This course outlines the steps and obligations that need to be taken by a sponsor of a new drug, or product, before the new drug is available for sale.  Discussions will include required steps specific to the investigational drug approval process, and when applicable, device clinical trials specific to premarket approvals (device trials with human subjects).

Topics include:
      ·          Financial arrangements that must be disclosed
      ·          The requirements for financial disclosure
      ·          Who is responsible for disclosing financial information
      ·          How FDA evaluate the financial information that clinical investigators disclose