Clinical Trial Deviations and Amendments

When FDAMA first came out in 1997, Congress instructed FDA to find a way for device manufacturers to make changes during the course of a clinical study without having to get prior approval. Eventually, §812.35 IDE Supplements was issued. It is a short section, just a couple of paragraphs. The real meat is in a guidance document called Changes or Modifications During the Conduct of a Clinical Investigation (May 01).

In the guidance FDA identifies three categories of IDE amendments: administrative changes (to be tabulated in the annual report), non-significant amendments (the sponsor can make the change and tell FDA later in a 5-Day Notice), and amendments (changes which require prior FDA approval.)

If we think about it, non-significant amendments are really planned deviations, and we can use this guidance to develop policies for managing the many clinical trial deviations that inevitably occur.

In developing the 3-hour workshop "Deviations and Amendments" I used this logic to walk through many examples of deviations taken from FDA warning letters with the goal of being able to identify deviations when they occur in a study and determine the reporting requirements. If you are a monitor who is responsible to identify deviations in the field, or a manager responsible for reporting them, this workshop will help clarify your thinking. --> more information