Checklist

Required by OSP

_____ Signed Document Summary Sheet 
_____ Signed Detailed Internal Budget*
(Note: If the Detailed Internal Budget contains Patient Care procedures, research pricing should be obtained from the Clinical Research Compliance and Education office contact Johanna Chesley - 801-213-3604. 

_____ Copy of Protocol Billing Grid*
_____ Budget Summary*
_____ Copy of Clinical Service Agreement (if Sponsor has provided contract to PI)
_____ Copy of Confidential Disclosure Agreement (if applicable)
_____ Copy of IRB approval (when available)
_____ Any changes made to budget, protocol, or investigator that might affect the contract
(Note: Changes to the protocol that affect Hospital Patient Care Procedures must be reviewed and approved by the Office of Clinical Research Compliance and Education.)


*OSP does not need immediately. You can submit your Contract and DSS to OSP while working on your budget and IRB submission.
Often requested by Sponsor:
_____ FDA (Food & Drug Administration) Form 1572 forms available at: http://www.fda.gov/opacom/morechoices/fdaforms/fdaforms
_____ FDA Disclosure: Financial Interests & Arrangements of Clinical Investigators forms available at: http://www.fda.gov/opacom/morechoices/fdaforms/fdaforms
_____ Notice of IRB approved protocol and patient consent/authorization
_____ IRS W-9 Form signed by the University of Utah available in OSP or at www.tax.utah.edu