Minimum Required Documents

Go here to submit documents for budget amendments.

• Protocol or other document that includes a Schedule of Event
• Contract template
• Payment schedule - external budget
• If applicable, B&B Workbook
• If Coverage Analysis is required, draft ICF
• NEW REQUIREMENT: Study Operational Plan
• If applicable, CTRU pricing
• If applicable, PI Waiver

• Protocol or other document that includes a Schedule of Event
• If applicable, B&B Workbook
• If Coverage Analysis is required, draft ICF
• If Coverage Analysis is required, complete Study Operational Plan _ CA Worksheet
• If applicable, CTRU pricing
• If applicable, PI Waiver
• If available, Sponsor budget template or any Sponsor specific guidance/instruction on budget preparation