jcri business operations – post-award. processes relating to the collection of sponsored clinical...
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JCRI Business Operations – Post-Award
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• Processes relating to the collection of sponsored clinical trial funding
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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
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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.
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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
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Study name FAKE Date established 9/8/2014PI Dr. Joseph Smith ORA Account No.080-18014-J97801Sponsor: ABC Pharmaceutical Sponsor contact nameCoordinator Paul Jones Sponsor contact emailNotes:
-$ Screening/ Baseline
Visit 1: Hour 6
Visit 2: Hour 12
Visit 3: Hour 24
Visit 4: Hour 48
Visit 5: Hour 72
Visit 6: Hour 96 Visit 7: Discharge TOTAL
$2,754.00 $2,793.00 $1,700.00 $1,265.00 $1,870.00 $1,192.00 $1,076.00 $1,261.00 $13,911.00
$2,503.64 $2,539.09 $1,545.45 $1,150.00 $1,700.00 $1,083.64 $978.18 $1,146.36 $12,646.36$577.76 $585.94 $356.64 $265.38 $392.31 $250.07 $225.73 $264.55 $2,918.39
$1,925.87 $1,953.15 $1,188.81 $884.62 $1,307.69 $833.57 $752.45 $881.82 $9,727.9722.98 23.31 14.19 10.56 15.61 9.95 8.98 10.52 116.1032.49 32.42 19.73 14.68 21.70 13.84 12.49 14.64 161.98
Subject NameSubject ID DOB W9 (Y/N) MRN
Screening/ Baseline Visit 1 Visit 2 Visit 3 Visit 4 Visit 5: Visit 6: Visit 8 Notes (Indicate any visit activities not performed
Patient Payments
Subject NameSubject ID
Screening/ Baseline
Visit 1 Visit 2 Visit 3 Visit 4 Visit 5: Visit 6: Visit 8
Total Expected Realtime payment
Total 10% holdback due
at study completion
Total Payment
0 0 -$ -$ -$ -$ -$ -$ -$ -$ -$ -$ 0 0 -$ -$ -$ -$ -$ -$ -$ -$ -$ -$ -$ 0 0 -$ -$ -$ -$ -$ -$ -$ -$ -$ -$ -$ 0 0 -$ -$ -$ -$ -$ -$ -$ -$ -$ -$ -$ 0 0 -$ -$ -$ -$ -$ -$ -$ -$ -$ -$ -$
Total Expected Realtime payment
-$
Total 10% holdback due at study completion
-$
Total Payment-$
# Hours (CRC)
Payment less 10% holdback (holdback received upon closure of
study)
Grand Total A/R
PaymentSubject Log
Indirect (30%)Real Payment
# Hours (CRN)
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Subject ID Date of Visit Amount to Be Invoiced Subject ID Date of Visit Amount to Be Invoiced-$ -$ -$ -$ -$ -$ -$ -$ -$ -$ -$ -$ -$ -$ -$ -$ -$ -$ -$ -$ -$ -$ -$ -$ -$ -$ -$ -$ -$ -$ -$ -$ -$ -$ -$ -$ -$ -$ -$ -$ -$ -$ -$ -$ -$ -$ -$ -$ -$ -$ -$ -$ -$ -$ -$ -$ -$ -$ -$ -$
Total: -$ Total: -$
TOTAL Requiring Action -$
Unscheduled Safety Visit Discharge Visit
Additional Forms
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Date Invoice Amount Date Invoice Amount Date Invoice Amount7/2/2015 2,000.00$ 2/12/2015 1,500.00$ -$
-$ -$ -$ -$ -$ -$ -$ -$ -$ -$ -$ -$ -$ -$ -$ -$ -$ -$ -$ -$ -$
Total 2,000.00$ Total 1,500.00$ Total -$
-$
Continuing Review Amendment (Full) Amendment (Expedited)
TOTAL Requiring Action:
IRB Activity
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Date Amount9/15/2014 16,550.00$ 7/17/2015 8,850.00$ Pre-screening for 107 subjects, IRB Continuing review, IRB amendment
Invoices SubmittedCommentElectronic data capture, study start-up fee, administration fee, medicare analysis fee, Initial IRB fee
Invoices Submitted
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Total outstanding patient payment expected realtime 1,000.00$
Payments received (Patient Visits-Main Study) Total 10% holdback due upon study completion 9.09$ Date Check # Amount Notes Total patient A/R 1,009.09$
3,018.18$
-$ Total patient payments received
Invoiced per Additional FormsDate Invoice # Amount Notes
-$ Total patient payments received-$ Total patient payments received
Invoiced per IRBDate Invoice # Amount Notes
7/17/2015 J97801-RM-2015-2 3,500.00$
3,500.00$ Total patient payments received
Financial Summary of A/R
Grand Total Study A/R (or Items requiring Invoicing)
Financial Summary of Accounts Receivable
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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
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• 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.
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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
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Ensures that studies are billed for research specific procedures
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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
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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
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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
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Clinical Research Coordinator’s Role
• Keep the billing and compliance grid available• Be prepared to answer questions your Clinical
Research Administrator may have
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Request for Payment form (RFP)•Petty cash•Check payments•Payments to vendors
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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
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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
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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
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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