Protocol Changes

  • The protocol is located in the Basic Information section of the study application.  In the Modification submission, remove the outdated protocol and replace with a tracked changes version of the revised protocol.
  • Remember to update the version date when revising the protocol.
  • If applicable, also upload the Summary of Changes and any other relevant sponsor correspondence.
  • Editing the protocol may affect other parts of the study record.  Go through and update the study application to reflect all changes in the protocol.