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

Additional Forms

IRB Activity

Invoices Submitted

Financial Summary of Accounts Receivable

Clinical Research Coordinator Role Communication with your JCRI Clinical Research Administrator is key 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,

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,

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, Michael Caggiano, Team Lead, Jennifer Lott, Team Lead, Jenny Campbell, Clinical Research Administrator, LouEllen Daniel, Clinical Research Administrator, Ryan Massimilla, Clinical Research Administrator, Mary Rose Taft, Clinical Research Administrator,