Business Operations Pre-Award

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

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

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 must be reviewed, negotiated and executed by the PI, University Official and the Company.

Negotiation CDA’s are usually straightforward and require little negotiation Point of contact: Roseann Talarico – Most are negotiated within 5-10 business days Include the name, address, telephone number and the Sponsor/CRO /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

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

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

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

JCRI Business Operations Coverage Analysis & Budget

Coverage Analysis

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

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

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

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

Clinical Trial Budget

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

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

Start-Up Costs

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

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

Other Costs

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

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

Clinical Trial Agreement

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

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

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

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

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, 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,