CLINICAL TRIAL FINANCIAL PROCESS
RESEARCH TEAM SELF-ASSESSMENT WORKSHEET
Study Name___________________________________________________________________________________________________________
IRB Number_____________
Date Review Completed___________________________
Principal Investigator_______________________________________
Billing Grid? YES
NO (circle one)
Budget Worksheet YES
Reviewed By:_______________________________
Study Coordinator___________________________________________
NO
Number of Subjects enrolled____________________________
Budget/ Billing Grid Review
Issue
Comments
Y / N / NA
1. Is the trial for an IDE device?
2. If not an IDE trial, does the trial qualify under Medicare
NCD? (check for all four criteria)
3. If IDE, was permission obtained from the MC Contractor?
(not required if no MC subjects to be enrolled)
4. Does the CTA have a detailed budget?
5. If the CTA does not have a detailed budget, does the
study team have one on file?
6. Does the research team have a billing grid?
If no to grid questions, create or amend the grid
7. General nature of funding? Is Sponsor paying for all?
Billing to Insurance?
Is there a mixture of both?
8. Does the grid include all clinical services required by the
Protocol?
9. Does the grid clearly define what is Sponsor paid?
10. Is the Grid consistent with the budget?
11. Is the grid consistent with MC billing guidelines?
12. Is Sponsor paying for unbillable items/services
13. Does trial need an NCT #
Place here if yes
Informed Consent Form Review (ICF)
14. Is the research-related injury paragraph consistent with
If not, correct ICF and resubmit to IRB
the CTA?
15. Does the cost section clearly identify what the patient
must pay for?
“
16. Is the cost section consistent with the budget?
“
Either ICF or Grid must be corrected
17. Is the cost section consistent with the billing grid?
18. Are any services promised as free in the ICF which are
legally billable? (not being paid by sponsor)
If yes, correct ICF and resubmit to IRB 9if subjects were billed,
research team must request refund to subject/insurer and bill
research accounts
Verification of Bills Received by Research Team
19. Have any participants been enrolled in the study and
received study items or services?
20. Have the consented subjects been identified and flagged
appropriately for billing purposes?
21. Does the research team/site have a process for verifying
all bills received for all participants (sponsor-funded)
If not, develop a process (SOP)
22. For participants who received sponsor-funded services
more than 60 days prior to this review, is there
documentation (ledger, bills, etc.) that the team
received the bill?
Tracking and Reconciling Sponsor Payments Obligated by the Study Contract
23. Is there a system in place to track the study payments
If not, develop a process (SOP)
owed by the sponsor?
24. Is there an invoicing process and an identifiable invoice
tracking method to ensure that all earned payments are
received?
“
25. Are sponsor payments being reconciled with what is
owed by the sponsor?
“
Additional Comments:
V1 9/15/2014