Device Study

Who needs to be listed on the delegation of authority log?

All individuals listed on the investigator agreement should also be listed on the Delegation of Authority log & trained on the protocol & their responsibilities.  This training must be documented by a training log/record that includes the training topics (e.g., protocol and device operation) and name of trainer.

Who needs to complete financial disclosure forms?

All Individuals listed on the investigator agreement or participating in the investigation must provide information to the IDE sponsor about their financial interests. Sponsor-investigators are required to collect this information from all participating investigators at all sites involved in the clinical investigation prior to allowing participation in the investigation. This includes studies conducted under an abbreviated IDE. See financial disclosure certification formNOTE: The FDA financial disclosure certification form is both separate from and in addition to the information collected by Emory’s Conflict of Interest Office and/or any financial disclosure forms required by NIH.

Can I use an investigational device outside of a clinical trial?

Expanded Access regulations provide a mechanism to use an unapproved medical device outside of a clinical trial.  FDA regulations use the term "Expanded Access" although you may also see the terms "compassionate use" or "treatment use".  Expanded access for devices includes emergency use and treatment use of an investigational device to treat a patient with a serious or immediately life-threatening disease or condition for whom there are no comparable or satisfactory alternative treatment options.  See Expanded Access.

Is there is a mechanism within Emory for secure email with the FDA?

Yes. Secure email configuration which allows email communication during the submission process has been completed and the FDA considers these email domains secure:

Use of secure email allows communication between FDA and sponsors.  It is not a substitute for formal submissions.  Formal submissions (e.g., new INDs and amendments)  must be submitted to the respective center’s document room (paper submissions) or via the electronic gateway, as applicable.

For more information see FDA Guidance: Best Practices for Communication Between IND Sponsors and FDA During Drug Development