Overview
A fully developed clinical protocol is the basis for both the IRB application and the initial IDE submission to FDA.
Step1
Review the Protocol Template.
- Review the IDE Protocol Template for required content.
- An alternative template protocol can be found here from the NIH National Institute on Aging.
- Consider whether the study meets the criteria for an Early Feasibility Study (EFS)
Step2
Create a Protocol Synopsis.
The protocol synopsis will be valuable if you are planning a Q-Submission (Pre-IDE).
Step3
Compile References Cited.
Compile a reference list, to include all published articles and unpublished reports or manuscripts cited. Collect a copy of each article or report listed.
Step4
Device Information
Device safety information should be integrated into the protocol.
For approved or cleared devices, review and retain the specific language of the FDA indications.
In addition, your safety plan should acknowledge known safety risks from the approval/clearance information and incorporate relevant safety monitoring into the protocol - or show why it is not relevant to the disease under study.