Submit Site

A Sponsor/CRO requesting review of an additional site of a previously approved protocol must submit:

Research Site Submission Form
Copy of the 1572 Form or the Non-IND/Device Studies Form
Curriculum vitae of each investigator
Copy of the Principal Investigator's current medical license

Refer to the

Submission Checklist for additional information.

NOTICE: Effective November 3, 2008, WebPortal users will no longer receive faxed copies of incomplete Site submissions requiring follow-up.

The submission deadline for an additional site of a previously approved protocol is
4 p.m. EST. If a site submission is received after the 4 p.m. EST deadline, it will be recorded as received on the next business day.