Protocol Modifications

Throughout the course of the study many things may be changed or modified this may include study procedures may be added or discontinued, visits may be dropped, personnel may change, etc. Any change to the study protocol, personnel, etc. should be submitted to the reviewing IRB (in most cases the Penn IRB unless there is a reliance agreement in place. For more information on submission please review the Penn IRB site https://irb.upenn.edu/homepage/formsandtemplates/

Sponsor

When a Sponsor modifies the protocol they must assess how the changes impact reporting, vendors, database, training, and any other trial related activities. Some resources to assist you with doing this include:

• Zone 2 Core Document Change Control
• Protocol Training Log
• FDA Reporting and /or IND IDE Exemption Amendment Risk Assessment 
• PI signature Page (coming soon)