This protocol has been submitted to the Food and Drug Administration under the Investigational New Drug (IND) regulations. The date of submission was ___________. __________________________ (sponsor) agrees to notify the Cancer Information Products and Systems (CIPS) staff if pertinent parameters of the protocol are revised by us or the FDA. You agree to contact the CIPS staff if the protocol is placed on clinical hold, terminated, placed on inactive status or if the FDA notifies you that the investigation is exempt from IND regulations.
Protocol Title: ____________________________ Protocol ID: _____________________________ _______________________________________ (Print Name)
_______________________________________ (Signature)	_____________ (Date)
______________________________ (Telephone Number)

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