Overview
A fully developed clinical protocol is the basis for both the IRB application and the initial IND submission to FDA.
Step1
Review the IND Protocol Template
Review the IND Protocol Template external site (opens in a new window) for required content.
Step2
Create a Protocol Synopsis
Start with a protocol synopsis (page 7 and 8 of the protocol template).
The protocol synopsis will be valuable if you are planning a pre-IND meeting.
Step3
Compile References Cited
Compile a reference list; include all published articles and unpublished reports or manuscripts cited. Collect a copy of each article or report listed.
Step4
Include Product Information
Product information should be integrated into the protocol.
For approved medications, review and retain the Prescribing Information.
In addition, your safety plan should acknowledge known safety risks from the prescribing information and incorporate relevant safety monitoring into the protocol - or show why it is not relevant to the disease under study.