Fillable Proposal Sign-Off Form (Page 4 of 4) in pdf

SECTION B: Prospective Reimbursement Analysis (PRA) (Note 1)

If Question 1 in the

section was answered “Yes”, please check

ADMINISTRATIVE AND POLICY CONSIDERATIONS

one of the appropriate boxes below:

The clinical research study’s clinical procedures constitute a clinical trial (i.e. there is

an investigational drug, device or treatment). The PI has signed the following

three (3) worksheets (copies are attached to this sign off form):

PRA

Template, Participant Grid/Billing Plan and Total Budget comparison

worksheet (refer to Note 2 and Note 3).

The clinical research study’s clinical procedures constitute a clinical trial (i.e. there is

an investigational drug, device or treatment) and the sponsor has indicated it will pay

for all visits and procedures (i.e. nothing will be billed to third party insurance). The

PI has signed the following two (2) worksheets (copies are attached to this

sign off form):

Participant Grid/Billing Plan and Total Budget comparison

worksheet (refer to Note 3).

The clinical research study is not a clinical trial (i.e. there is not an investigational

drug, device or treatment). The PI has signed the following two (2) worksheets

(copies are attached to this sign off form): Participant Grid/Billing Plan and

Total Budget comparison worksheet (refer to Note 3).

PRINCIPAL INVESTIGATORS’ CERTIFICATION

In signing below the Principal Investigator(s) certify that he/she has completed the Blackboard

clinical trial training (Course CT-01).

Date:

________________________________________________

__________________________________

Principal Investigator(s) Name(s)

NOTE 1: The University of Rochester Clinical Research Standard Operating Procedures Regarding Financial Oversight and Billing Compliance

defines a Prospective Reimbursement Analysis as “the process of determining and documenting what procedures, items and tests in a

protocol are standard of care or strictly related to research. This information is then used to determine the appropriate payer of such

activities” (SOP 1.1).

NOTE 2: The PRA Template is a questionnaire that assists with the determination whether a clinical trial is a “Qualifying trial” as per Centers for

Medicare and Medicaid Services guidelines. The PRA Template is a worksheet within the UR’s Budgeting Workbook for clinical trials,

accessible in the Clinical Trial Resources Share Point site (that is accessible through the link on this web page

NOTE 3: The Participant Grid/Billing Plan is an EXCEL worksheet on which is documented the proper payer for each clinical procedure for each

visit in a clinical research study plan. A Total Budget comparison worksheet allows comparison of the sponsor’s financial offer to the

UR’s internally prepared budget and indicates whether a potential deficit or surplus exists. . The Participant Grid/Billing Plan and the

Total Budget comparison are worksheets within the UR’s Budgeting Workbook for clinical trials, accessible in the Clinical Trial

Resources Share Point site (that is accessible through the link on this web page:

Form Rev. 01/01/15

Page 4

Proposal Sign-Off Form Page 4