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 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)

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

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

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

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

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