You will also need to have IRB approval for the central protocol, informed
consent form (ICF) and assent form for minors. Knowing that
each site will need to make necessary amendments to the ICF to fulfill their site's requirements, please send any proposed changes first to
Elise Olsen @ Elise.email@example.com before submitting to your IRB in order to insure the forms
remain consistent with the approved centrally approved forms.