Food and Drug Administration Documents

Individuals who are performing investigations on new drugs or medical devices must fill out the appropriate Food and Drug Administration forms to be approved by the Institutional Review Board along with a protocol application in VERAS. Any VERAS applications that do not have the correct forms attached at the time of submission may be returned and the investigator will have to resubmit the protocol application with the appropriate forms and FDA information.

• To obtain the appropriate application for drugs, visit the FDA's Electronic Forms page for Drug Applications.
• To obtain the appropriate application for medical devices, visit the FDA’s Electronic Forms page for Investigational Device Exemptions.

If you have any questions concerning the forms which you will be required to complete, email irb@uidaho.edu.