Business Operations Pre-Award

1. Business OperationsPre-Award

2. Confidential Disclosure Agreements (CDA)/Non-Disclosure Agreements (NDA)

3. Two Types • One Way • A company may want to send a protocol to the Principle Investigator (PI) so that he/she can decide whether to participate in the trial • The protocol will have confidential information that the company needs to safeguard • The sponsor may wish to support a Principal Investigator by supporting travel to a conference which may have confidential information • Two Way (Mutual) or One Way Out • A Principal Investigator may want to request a sponsor to support their own research

4. How does this work? • Principal Investigator contacts University administration looking for assistance • Sponsor contacts PI/Coordinator • Sponsor contacts University administration • In order to protect the University and the PI, all CDA’s require University signature • Each mustbe reviewed, negotiated and executed by the PI, University Official and the Company.

5. Negotiation • CDA’s are usually straightforward and require little negotiation • Point of contact: Roseann Talarico – 3-4743 roseann.talarico@jefferson.edu • Most are negotiated within 5-10 business days • Include the name, address, telephone number and the Sponsor/CRO email/phone • If needed, include a note with any concerns about the CDA or what confidential information University may wish to protect • Once completed PI will receive executable copy – return to complete the execution process • Fully executed copy sent to PI for recordkeeping

6. What is required to begin the business process? • Possible indicators • CDA executed • Cancer Center • MDG/PRC approvals • Department contacts business office • Electronic Proposal Transmittal Form (ePTF) • What is it/what is it for? • It is an electronic mechanism for Jefferson to manage, maintain, and approve research • Used for all research at Jefferson

7. Electronic Proposal Transmittal Form (ePTF)What is needed? • Materials required to complete (ePTF) for approval • Protocol • Investigator Brochure (IB) • Draft Informed Consent (ICF) • Clinical Trial Agreement (CTA) • Sponsor Budget

8. Electronic Proposal Transmittal Form (ePTF)What is the approval process? • Clinical trials • First Round approval • Contract/MCA/Budget • Process may begin • Second round approval • MCA/Contract/Budget negotiated • IRB approval letter and informed consent

13. JCRI Business OperationsCoverage Analysis & Budget

14. Coverage Analysis

15. Materials needed to conduct a Coverage Analysis From Study Team: • Same as (ePTF) process • Protocol • Investigator Brochure (IB) • Draft Informed Consent (ICF) • Clinical Trial Agreement (CTA) • Sponsor Budget • Approved electronic proposal transmittal form (ePTF) • First round only

16. What is a Coverage Analysis? • Document that determines the appropriate payor (i.e. Sponsor, Medicare or third party payor) for each item and service required by a clinical research trial

17. Why is a Coverage Analysis important? • Reduces risk for submitting false claims • Billing for services not part of a qualifying clinical trial • Billing for items and services promised/paid for by Sponsor • Billing for research only items and services • Assists in budget negotiations with Sponsor/CRO • Identifies costs that need to be accounted for in the sponsor budget • Basis of billing compliance/audits • Provides evidence of due diligence and a mechanism for compliance with billing rules

18. Coverage Analysis Process • Receive all materials from the study team • Create a grid that reflects all clinical events and time points in the protocol • Review clinical guidelines along with CMS national and local coverage determinations to identify the appropriate payor for each event • Send the CA to PI/SC for review and approval • Approve or revise the CA as necessary

20. Clinical Trial Budget

21. Develop a financial plan that encompasses all phases of the study: • Start-up costs • Institutional costs • Other costs incurred throughout the study • Subject costs

22. Develop a financial plan that encompasses all phases of the study: • Start-up costs • training, meetings, IRB/regulatory work, source document creation • Institutional costs • Other costs incurred throughout the study • Subject costs

23. Start-Up Costs

24. Develop a financial plan that encompasses all phases of the study: • Start-up costs • training, meetings, IRB/regulatory work, source document creation • Institutional costs • F&A, IRB fees, billing compliance fees • Other costs incurred throughout the study • Subject costs

27. Develop a financial plan that encompasses all phases of the study: • Start-up costs • training, meetings, IRB/regulatory work, source document creation • Institutional costs • F&A, IRB fees, billing compliance fee • WIRB/Quorum – One time fee $2,500 • Other costs incurred throughout the study • site monitor fees, IRB work on continuing reviews or amendments, dry ice, close-out costs, etc. • Subject costs

28. Other Costs

29. Develop a financial plan that encompasses all phases of the study: • Start-up costs • training, meetings, IRB/regulatory work, source document creation • Institutional costs • F&A, IRB fees, billing compliance fee • WIRB/Quorum – One time fee $2,500 • Other costs incurred throughout the study • site monitor fees, IRB work on continuing reviews or amendments, dry ice, close-out costs, etc. • Subject costs • Any items that are not billable to insurance or provided by the sponsor

31. Accomplished by considering all stakeholders input: • PI and Study Coordinator • Radiology • Pathology • Pharmacy • Hospital Billing • Professional Services Billing • Other departments • Sponsor

32. Clinical Trial Agreement

33. What is required to complete a contract? • Who wrote the protocol? • Sponsor • Clinical Trial Agreement • PI/Jefferson • Investigator Initiated Agreement • Is the sponsor contract new or previously negotiated? • If new – review/red line changes • Forward to legal • If previously negotiated – similar protocol • Review/red line changes • Forward to sponsor

34. What is required to complete a contract? • Negotiate terms • Ensure budget, billing and payment terms are acceptable • Is the IRB approved? • Approval letter and informed consent reviewed • Sponsor and protocol must match contract • Subject injury and indemnification language • Different terms in each but intent must be the same • (ePTF) secondary approvals

35. What is required to complete a contract? • Execute • Forward to PI • Return to sponsor • PDF or mail • Account set up • Establishment letter to staff and accounting • MCA includes account number sent to staff and billing

37. Post Account Establishment • Modifications/Amendments • No cost extension • Change in PI • Modification to protocol • No budget modification • Modification to protocol • Budget modification • $5,000 or greater • (ePTF) supplement • Approvals, etc. • Follow same SOPs as a new clinical trial

40. How to initiate the process Please, please, and please reach out to your clinical research administrator for more 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