JCRI Business Operations –
Post-Award
• Processes relating to the collection of sponsored clinical trial
funding
Invoicing
Clinical Research Administrator submits invoices to the
sponsor
• Initial invoice includes startup fees, initial IRB fees, billing and
compliance and any other items listed in the clinical trial
agreement
• Ongoing invoices include IRB fees & IRB prep fees, pharmacy
monthly maintenance, site monitor fees, advertising, protocol
specific procedures, other items listed in clinical trial
agreement
Milestone Payments
• Based on finalized contract, milestone payments would
apply if TJU is paid upon enrollment of a certain number
of patients, completion and collection of case report
forms, etc.
Patient Tracking
• Study calendar set up based on finalized budget
• Calculates amounts due based on the patient activity within the
study
• May include conditional procedures or services, based on the
study
Study name
PI
Sponsor:
Coordinator
Notes:
Date established
9/8/2014
ORA Account
080-18014-J97801
No.
Sponsor contact name
Sponsor contact email
FAKE
Dr. Joseph Smith
ABC Pharmaceutical
Paul Jones
Grand Total A/R
Subject Log
$
Visit 3: Visit 4: Hour
Hour 24
48
Screening/
Baseline
Visit 1:
Hour 6
Visit 2:
Hour 12
$2,754.00
$2,793.00
$1,700.00
$1,265.00
$2,503.64
$577.76
$1,925.87
22.98
32.49
Screening/
Baseline
$2,539.09
$585.94
$1,953.15
23.31
32.42
$1,545.45
$356.64
$1,188.81
14.19
19.73
Visit 1
Visit 1
Payment
Visit 5:
Hour 72
Visit 6:
Hour 96
Visit 7: Discharge
TOTAL
$1,870.00
$1,192.00
$1,076.00
$1,261.00
$13,911.00
$1,150.00
$265.38
$884.62
10.56
14.68
$1,700.00
$392.31
$1,307.69
15.61
21.70
$1,083.64
$250.07
$833.57
9.95
13.84
$978.18
$225.73
$752.45
8.98
12.49
$1,146.36
$264.55
$881.82
10.52
14.64
$12,646.36
$2,918.39
$9,727.97
116.10
161.98
Visit 2
Visit 3
Visit 4
Visit 5:
Visit 6:
Visit 8
Visit 2
Visit 3
Visit 4
Visit 5:
Visit 6:
Visit 8
Payment less 10% holdback
(holdback received upon closure of
study)
Indirect (30%)
Real Payment
# Hours (CRN)
# Hours (CRC)
Subject
ID
Subject Name
DOB
W9 (Y/N) MRN
Notes (Indicate any visit activities not performed
Patient Payments
Screening/
Baseline
Subject
ID
Subject Name
0
0
0
0
0
0
0
0
0
0
$
$
$
$
$
-
$
$
$
$
$
-
$
$
$
$
$
-
$
$
$
$
$
-
$
$
$
$
$
-
$
$
$
$
-
$
$
$
$
$
-
$
$
$
$
$
-
Total
Expected
Realtime
payment
$
$
$
$
$
-
Total 10%
holdback due
at study
completion
$
$
$
$
$
-
Total Payment
$
$
$
$
$
-
$
-
$
-
$
-
Total Expected Realtime
payment
Total 10% holdback due at
study completion
Total Payment
Additional Forms
Subject ID
Unscheduled Safety Visit
Date of Visit
$
$
$
$
$
$
$
$
$
$
$
$
$
$
$
$
$
$
$
$
$
$
$
$
$
$
$
$
$
$
Total:
$
Amount to Be Invoiced
Discharge Visit
Date of Visit
Subject ID
-
Total:
TOTAL Requiring Action
Amount to Be Invoiced
$
$
$
$
$
$
$
$
$
$
$
$
$
$
$
$
$
$
$
$
$
$
$
$
$
$
$
$
$
$
$
-
$
-
IRB Activity
Continuing Review
Date
Invoice Amount
7/2/2015 $
2,000.00
$
$
$
$
$
$
$
Total $
2,000.00
Amendment (Full)
Date Invoice Amount
2/12/2015 $ 1,500.00
$
$
$
$
$
$
$
Total $ 1,500.00
Amendment (Expedited)
Date Invoice Amount
$
$
$
$
$
$
$
$
Total $
-
TOTAL Requiring Action:
$ -
Invoices Submitted
Invoices Submitted
Date
9/15/2014 $
7/17/2015 $
Amount
Comment
16,550.00 Electronic data capture, study start-up fee, administration fee, medicare analysis fee, Initial IRB fee
8,850.00 Pre-screening for 107 subjects, IRB Continuing review, IRB amendment
Financial Summary of Accounts Receivable
Financial Summary of A/R
Total outstanding patient payment expected realtime
Payments received (Patient Visits-Main Study)
Date
Check #
Amount
$
Notes
-
Total patient payments received
Invoiced per Additional Forms
Date
Invoice #
Amount
$
$
Notes
-
Total patient payments received
Total patient payments received
Invoiced per IRB
Date
Invoice #
7/17/2015 J97801-RM-2015-2
Amount
Notes
$ 3,500.00
$
3,500.00 Total patient payments received
Total 10% holdback due upon study completion
Total patient A/R
Grand Total Study A/R (or Items requiring Invoicing)
$
1,000.00
$
$
$
9.09
1,009.09
3,018.18
Clinical Research Coordinator Role
• Communication with your JCRI Clinical Research Administrator
is key
• Email copies of IRB approval letters, documentation for
advertising and any other supporting documents for invoicing
• Ensure patient trackers are updated timely
• Ask questions to your Clinical Research Administrator
• Clinical Research Administrator should receive
all clinical trial payments from the sponsor
• Patient payments paid via CRF
• Payment entered as received on patient
payment sheet
• Payments reconciled against visits on patient
visit sheet. BOPS ensures payments received
match the amounts expected from the
sponsor.
Clinical Research Coordinator’s Role
• Any payments received related to a clinical trial by the
research staff should be forwarded to your Clinical Research
Administrator for deposit and proper accounting
• Be prepared to answer questions from the Clinical Research
Administrator about patient activity
Ensures that studies are billed for research specific procedures
Clinical Trial Billing
Entities
• Jefferson University Physicians (JUP)
• Bills related to clinical services sent monthly from JUP
Business Services
• Hospital
• Bills related to clinical services sent regularly from Hospital
Business Services
Jefferson University Physician (JUP) Bills
- Physician professional fees
- Examples: Physical exam, evaluation of MRI, ECG
interpretation, etc.
- Services get billed to grant or patient’s insurance for JUP
services. Review billing and compliance grid as reference
- Contact for JUP Billing
-
Merle Charlton, 3-3311
Hospital Bills
• Technical Fees for clinical trial services
• i.e. MRI cost, CT scan cost, some clinical labs, ECG cost, etc.
• Billed to grant or patient insurance as designated by
billing and compliance grid
• Contact for hospital billing
•
Ed Dunigan, 5-2521
Clinical Research Coordinator’s Role
• Keep the billing and compliance grid available
• Be prepared to answer questions your Clinical Research
Administrator may have
Request for Payment form (RFP)
• Petty cash
• Check payments
• Payments to vendors
Payments to Patients
• For payments made to patients, as compensation for study
related activities in the form of petty cash an RFP will be
submitted to your Clinical Research Administrator
• For check payments, the Request for Payment will be
submitted to your Clinical Research Administrator for
approval
Payment to Vendors
• Use Request for Payment form, enter vendor information
in the address section, attach any invoices and be sure to
check box for this to be included with the check.
• Forward the RFP to your Clinical Research Administrator
for approval
Clinical Research Coordinator’s Role
• Ensure you’ve included all information on the Request for
Payment and attached any required documentation
• Be prepared to answer questions or provide information
to your Clinical Research Administrator
Contact Information
•
•
•
•
•
•
•
Ronald Polizzi, Director, Business Operations JCRI, 3-2127
Michael Caggiano, Team Lead, 3-4746
Jennifer Lott, Team Lead, 5-2546
Jenny Campbell, Clinical Research Administrator, 3-4282
LouEllen Daniel, Clinical Research Administrator, 3-5390
Ryan Massimilla, Clinical Research Administrator, 3-2890
Mary Rose Taft, Clinical Research Administrator, 3-4265