Minimum Documents for Submission to CT RMG
Go here to submit documents to CT RMG for budget amendments.
Industry-Initiated Study
- 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
- If Coverage Analysis is required, complete Study Operational Plan _ CA Worksheet
- If applicable, CTRU pricing
- If applicable, PI Waiver
PI-Initiated Study
- 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
Resources
- CT Acuity Tool (coming soon!)