Financial Management of Clinical Research

1. Financial Management of Clinical Research Office of Research Compliance NSLIJHS 516-562-2018

2. Overview • In 2007 over $91 million in External Funding was received for Service Delivery and Research projects throughout the Health System • Federal and state agencies have regulations governing how money may be spent and when financial statements must be filed • Sponsors often have additional reporting requirements outlined in the Notice of Grant Award or terms of the contract • Failure to comply with these terms can lead to reductions in funding, disallowed costs, and disbarment from future rounds of funding

3. Responsibilities • Who? • Principal investigators and designees (i.e. research coordinators); institution • What? • Appropriate budget development • Cost allocation and monitoring • Operational efficiencies • When? • Before the study begins • During the conduct of the study • Study close-out

4. Roles and Responsibilities • Fiduciary responsibility lies with the program manager (PM) or principal investigator (PI) of each awarded project. As such, it is the responsibility of the PI/PM of their designee to review at least monthly: • PeopleSoft Financial Status Reports to monitor expenses and request changes as necessary to ensure compliance with the terms and conditions of an award and to ensure that costs are being captured. • Salary and Labor Monitors and Effort Certification Report Forms to ensure that labor and effort are appropriately allocated and are in compliance with the terms and conditions of an award. • Grants Management staff in the Office of Sponsored Programs (for service delivery), Grants and Contracts (for research), BRANY (for industry sponsored studies) and Grants Financial Reporting (for both) provide administrative and technical support to assist PI/PMs in meeting requirements • PeopleSoft Financial Reporting team plays a significant role and we will discuss how to get access to reports later in this presentation

5. NS-LIJ Policies • Healthport: System wide Research Policies that impact financial management for clinical research • Time and Effort Reporting • Intellectual Property • Compensation for Research Subjects •        Research Study Participant Payment Form • Research Billing Procedure for Outpatient Services, Inpatient Services and Ancillary Testing •        Medicare Outpatient Payment Rates •        Inpatient Research Subject Registration •        Outpatient Research Subject Registration •        Special Purpose Fund Account Set Up Form • Grant Close Out • Grant Applications for External Funding •        Office of Sponsored Programs Grant Application Routing Form •        Office of Grants & Contracts Grant Application Routing Form • Principal Investigators for Sponsored Research • Research at the North Shore-LIJ Health System • Research Misconduct • Office of Research Compliance • www.nslij.com/orc • Office of Grant and Contracts • www.nslij.com/ogc

6. Before a study begins: Budget Development • Do create a project-specific detailed budget that includes all protocol procedures and associated costs, even if it’s not required by the sponsor or if the study is not yet funded. You should do this BEFORE you agree to take on a study. • Don't enter into final budget negotiations and execute an agreement until you have created a final budget and are confident you have identified all study costs. • Don'tgive final approval to the budget without reviewing the final protocol. • Doread the contract language related to budget and payment carefully. Consult with Grants, BRANY, or Finance if you need clarification of terms.

7. Budget Development • How do I calculate an appropriate per patient reimbursement? • If the sponsor has provided a detailed budget, this makes a good starting point; however, sponsor-prepared budgets do not always include all the costs associated with the study. Before beginning, both the PI and study coordinator should review the study protocol or schema with BRANY or OGC with the following in mind: • Difficulty and/or complexity of study • Study preparation requirements • Patient acuity and age • Length of study • Inclusion/exclusion criteria for patient recruitment

8. Budget Development • When working with BRANY or OGC when calculating your budget you should consider the following non-patient specific costs in your per-patient reimbursement in addition to protocol procedures: • Study start up costs: contract negotiation and review, time spent preparing and maintaining regulatory documents and IRB approval • Data management both while the study is active and during close out • CRF completion • Time spent with monitors • Advertising • Screening, including the costs of pre-screening before any subject is enrolled. • Archiving • Pharmacy storage and preparation costs • Shipping costs • In addition be sure that the payment schedule takes into account front loaded screening or dose escalation visits that may be more intensive then later visits. Failure to manage the timeline for when you are paid can often present problems. Be careful how you request payment based on milestones.

9. Per Patient Budgets and the NIH • Increasing in popularity • Must be based on actual costs • Cost Accounting Standard (CAS) 501 requires consistency in estimating, accumulating, and reporting costs • You cannot “profit” from NIH grants or contracts, all “credits” must be returned at the end of the grant or contract period • If the budget states that the per patient rate was calculated based on ancillary tests, the expectation is that the per patient amount will pay for those ancillary tests. This does not mean you cannot roll in personnel or other costs, but the budget will need to be clear from the start that these costs were rolled into the per patient calculation and how the expenses were verified.

10. Budget Development • Where can I get access to a complete list of procedures with charge rates? • Costs for ancillary procedures are charged to research grants based on the Medicare fee schedule. No matter what kind of insurance or lack of insurance a research subject has, the grant or contract will be charged the same amount that the health system would charge Medicare. • These costs are listed in the Medicare Outpatient Prospective Payment System (OPPS).All services paid under OPPS are classified into groups called Ambulatory Payment Classifications or APCs. Services in each APC are similar clinically and in terms of the resources they require. A payment rate is established for each APC and is hospital specific. • A spreadsheet which lists Medicare charges based on APCs effective January 1, 2009 for all health system entities has been posted on healthport under the policies tab. • Costs for inpatient stays: are facility and discipline specific and negotiated with the federal government by Finance. This rate is often referred to as the “bed day rate”. If you need to know the rate for a specific facility or discipline contact Larry Katz or Danny Halfant in Grants Financial Reporting for more information.

11. Post Award Management • Where can I locate the amount I am being reimbursed by sponsor for each patient or per patient visit? • The amount the site will receive should be documented in the clinical trial agreement (CTA) or grant budget. • Many budgets do not break out costs on a per visit basis rather they are calculated as a per patient reimbursement. • If your study sponsor simply provides a “per-patient reimbursement” you MUST develop a detailed study budget (its required under the Clinical Trials Billing Policy)

12. Post Award Management What is the process in obtaining fund (PeopleSoft #)? • The Office of Grants and Contracts or BRANY will initiate the start-up of a fund account (called a PeopleSoft #) for research projects and programs. • This process begins with OGC or BRANY requesting a fund number from the Department of Finance, followed by the development and dissemination of a Fund Memorandum. • The Fund Memorandum is generated from the Grants and Contracts or BRANY database and sent to key persons who will be involved with the management of the grant award, including the Principal Investigator, the Department Chair or Center head, and their respective Administrators. • If applicable, copies are sent to the Departments of Finance and Purchasing to monitor and report out on expenses and for reference when the purchase of materials and supplies are required for the conduct of the study.

13. What is PeopleSoft? • PeopleSoft is the health system’s financial and human resources tracking system, it is a series of databases that help manage operations. Two key areas are: • EPRO PS database in which eProcurement users can order supplies and perform the Desktop Receiving and Approving functions for requisitions. • EPMREPORTS PS database forviewing PeopleSoft EPM Reports, including all Monthly Financials, Salary Monitors, Position Control, Monthly Goods and Services, AP Voucher Distribution reports and other reports related to Financials and Budgeting. • If you are responsible for the administration, implementation, or oversight of externally sponsored research protocols you will need access to the appropriate PeopleSoft financial reports for those projects

14. Post Award Management • How do we get access to People Soft? • New users complete and submit a PeopleSoft User Security form and attend a PeopleSoft workshop, offered through the Center for Learning and Innovation. • Forms and instructions on this process may be found at the PeopleSoft website on Health Port. • PeopleSoft Home is available under Quick Links in the top right corner of the Health Port site.

15. What is “Time and Effort”? A process for capturing how an individual spends his/her effort over a given time period Reflected in percentages of total time (100%) worked in the health system regardless of where work is performed Total includes all effort (hours) spent to meet all commitments to the health system (Total hours will vary from person to person) Based on actual activities, but may be reasonably estimated Reported retrospectively or “after-the-fact” every MONTH Required by federal regulation Post Award Management

16. Effort is defined as the amount of time spent on a particular activity. Individual effort is expressed as a percentage of the total amount of time spent on work-related activities (clinical care, instruction, research, administration, etc.) % Effort = Project specific time All time expended to meet commitments in the Health System How is effort calculated?

17. How does it work? • Every month key research personnel will receive an Effort Certification Report Form (ECRF) from Research Compliance • Review the report, sign, and send back to Research Compliance • If changes need to be made they can be indicated on the form • Note if the change effects salary the appropriate position data change form MUST be submitted to Human Resources

18. Time and Effort Reporting • NOTE a change in Process: • Processing of effort report forms is moving from Grants Finance to Research Compliance as of April 10, 2009. • Completed forms should be sent to Gerry Kassoff at The Feinstein Institute for Medical Research at 350 Community Drive, Manhasset, NY 11030

20. Clinical Trial Management If my department is providing services to a research study what will my department be reimbursed for those services? If my department is asking another department to provide services what will we charged? • If your department is providing services your department will incur a cost and you will need to seek reimbursement for that cost from a sponsor, grant, contract, departmental fund, or operations. The entity reimbursing you is incurring the charge. • For example if a Cardiology study calls for an EKG, both the cost and the charge of the EKG might be the responsibility of Cardiology. • However if Cardiology provides EKG services to Gastroenterology, Cardiology incurs the cost and Gastroenterology should be charged for the cost of the EKG. • If there is external funding the Clinical Trials Billing Policy and Procedure must be followed and the appropriate project ID (peoplesoft #) will be charged • There should be no “special deals”. All research related costs for ancillary services are charged the same amount that the health system would charge Medicare. The schedule is available on healthport under the policies tab.

21. Clinical Trial Management • How long does it take to get reimbursed? • Grants Financial Reporting receives a report of costs to be charged to specific funds at the end of every month from patient accounts. If all the information is accurate, Grants Financial Reporting will charge the appropriate peoplesoft project ID and transfer funds to your department within 1 calendar month after receiving notification. • How do we know if we have been reimbursed for services our department has performed for researchers in the health system? • It will appear as a journal entry credit in your department’s PeopleSoft reports. • How do we know if we have been charged for a service provided by another department in the health system? • It will appear as an expense in your PeopleSoft Grant Fiscal Recap or Clinical Trial Fund Balance report.

22. Clinical Trial Management • How do we know if we have been paid by the sponsor? • Grants Financial Reporting provides this information.

23. Clinical Trial Management • How do I know what costs can be billed to insurance and which ones can or should be covered by a grant or contract? Am I allowed to charge this cost to a third party payer? • The decision that governs clinical research costs (with the exception of investigational devices) is called the National Coverage Decision for Routine Costs in Clinical Trials. The decision is made by the Center for Medicare and Medicaid Services or CMS: http://www.cms.hhs.gov/mcd/viewncd.asp?ncd_id=310.1&ncd_version=2&basket=ncd%3A310%2E1%3A2%3ARoutine+Costs+in+Clinical+Trials. • We apply this decision to all study subjects regardless of the subject’s insurance status as a significant amount of health system reimbursement is from CMS, most insurers follow their lead and we have to capture and bill costs equally.

24. Clinical Trial Management • Medicare covers the routine costs of qualifying clinical trials, as well as reasonable and necessary items and services used to diagnose and treat complications arising from participation in all clinical trials. (Note that there is a separate decision for investigational devices) • Routine costs in clinical trials include: • Items or services that are typically provided absent a clinical trial (e.g., conventional care); • Items or services required solely for the provision of the investigational item or service (e.g., administration of a noncovered chemotherapeutic agent), the clinically appropriate monitoring of the effects of the item or service, or the prevention of complications; and • Items or services needed for reasonable and necessary care arising from the provision of an investigational item or service--in particular, for the diagnosis or treatment of complications. • Costs that are not covered: • The investigational item or service, itself unless otherwise covered outside of the clinical trial; • Items and services provided solely to satisfy data collection and analysis needs and that are not used in the direct clinical management of the patient (e.g., monthly CT scans for a condition usually requiring only a single scan); and • Items and services customarily provided by the research sponsors free of charge for any enrollee in the trial.

25. Clinical Trial Management • If services provided in a research study are covered by a grant or contract and/or should not be billed to insurance, what do I do? • Follow the Health System’s Policy on Clinical Trials Billing • The purpose of this policy is to describe the process for capture and payment of costs associated with outpatient services, inpatient services and ancillary testing provided in the course of a clinical research study.

26. Clinical Trial Billing POLICY • It is the policy of the North Shore-LIJ Health System that all clinical services rendered during the course of a research study be billed to the appropriate PeopleSoft project number, third party payer, or individual in compliance with applicable state and federal regulations.   • Research procedures reimbursed by a research grant or contract may not be billed to a subject and/or their insurance carrier. • It is the research team’s responsibility to know which procedures and visits are required and covered by the research grant or contract.  • All clinical trial research studies must develop a budget and the budget must indicate which services are billable or non-billable. • The correct PeopleSoft Project # must be used when billing to a research grant or contract. 

27. Clinical Trial Billing: Outpatient Outpatient Process for hospital or office based procedures: • The investigator/study coordinator identifies that the subject is appropriate for the study and obtains informed consent. • The investigator/study coordinator determines whether or not the procedures are being paid for by the grant or contract by reviewing the detailed study budget. • If the investigator/study coordinator determines the procedures/visits are covered by the study budget they are therefore non-billable to the subject or 3rd party payer. • Complete requisition or prescription for services; attach the Outpatient Research Registration form. • If the procedure/visit is determined to be billable and not reimbursed by the study budget or grant • If the patient has insurance, obtain proper authorization • If the patient lacks insurance or insurance won’t cover the procedure ensure that the consent form advises the subject that these procedures are not covered.

28. Clinical Trial Billing: Outpatient When Patient Arrives for Visit (date of service) • Patient will be registered following normal facility procedures. • The investigator/study coordinator will provide the subject with a prescription or requisition attaching the Outpatient Research Registration form • Registration will record the following information to ensure research services are correctly billed: • If the procedure/visit is covered by the research study and is being billed via INVISION • Apply the registration to plan code F60 for NSUH Manhasset and enter the PeopleSoftproject number into the prior authorization AND policy number fields.  • Apply the registration to plan code GNT for LIJ, SCH, and ZHH and enter the PeopleSoft project number into the prior authorization AND policy number fields.  • If the procedure/visit is covered by the research study and is being billed via IDX • Apply the invoice to plan code RES for NSUH Manhasset and enter the PeopleSoft project Number into the prior authorization field.  • Apply the invoice to plan code GNT for LIJ, SCH, and ZHH and enter the PeopleSoft project number into the prior authorization field.  • If the procedure/visit is NOT covered by the research study’s grant or contract no form needs to be completed and registration staff should apply the registration to the subject and/or insurance

29. Clinical Trial Billing: Core Lab • Once a PeopleSoft project number has been received, the investigator/coordinator will contact the Core Lab Billing Office to set up a protocol specific account.  Each PeopleSoft project number must have a separate Core Lab Account #.  • The investigator/coordinator will provide the Core Lab with a Special Purpose Fund Account Set Up Form in order to create the account. The Core Lab will then provide the investigative site with a pre-printed research requisition form specific to the study protocol. • The investigator/study coordinator Identifies that a subject is appropriate for the study and obtains informed consent • The investigator/study coordinator determines whether or not the procedures are being paid for by the grant or contract by reviewing the detailed study budget. • If the investigator/study coordinator determines the procedures/visits are covered by the study budget and are therefore non-billable complete Core Lab research requisition and submit sample with research requisition to the Core Lab. • If the procedure/visit is determined to be billable and not reimbursed by the study budget or grant submit sample with clinical requisition to the Core Lab: • If the patient has insurance, obtain proper authorization. • If the patient lacks insurance or insurance won’t cover the procedure ensure that the consent form advises the subject that these procedures are not covered.

30. Clinical Trial Billing: Inpatient Process for Category A subjects (those hospitalized specifically for research): • The investigator/study coordinator identifies that the subject is appropriate for the study and obtains informed consent. • The investigator/study coordinator determines whether or not the hospitalization is being paid for by the grant or contract by reviewing the detailed study budget. • If the investigator/study coordinator determines the hospitalization is required by protocol and covered by the study budget and are therefore non-billable notify Admitting either prior to hospitalization or if already hospitalized at the time the subject becomes a research subject (day they sign consent); provide admitting with the Inpatient Research Subject Registration form. • If the hospitalization is determined to be billable and not reimbursed by the study budget or grant: • If the patient has insurance, obtain proper authorization. • If the patient lacks insurance or insurance won’t cover the procedure ensure that the consent form advises the subject that these procedures are not covered.

31. Clinical Trial Billing: Inpatient Process for Category B subjects (those hospitalized for medical necessity): • The investigator/study coordinator identifies that the subject is appropriate for the study and obtains informed consent. • The investigator/study coordinator determines whether or not hospitalization is required by the protocol, or whether services are being paid for by the grant or contract by reviewing the detailed study budget. • If the investigator/study coordinator determines that hospitalization is not required but that ancillary services are covered by the study budget and are billable notify Patient Accounts the day the subject is enrolled, (day they sign consent); provide patient accounts with the Inpatient Research Subject Registration form. • If procedures are determined to be billable and not reimbursed by the study budget or grant. • If the patient has insurance, obtain proper authorization. • If the patient lacks insurance or insurance won’t cover the procedure ensure that the consent form advises the subject that these procedures are not covered.

32. Clinical Trial Billing: Inpatient Admitting Procedure • Patient will be registered following normal hospital procedures. If this is a planned admission, Investigators must contact bed management and admitting prior to the day of admission • The investigator/study coordinator will provide admitting with the Inpatient Research Subject Registration form (Attachment A). • Admitting will record the following information to ensure research services are correctly billed: • If the procedure/visit is covered by the research study: • Apply the registration to plan code F10 for NSUH Manhasset and enter the PeopleSoft Project number into the prior authorization AND policy number fields • Apply the registration to plan code GNT for LIJ, SCH, and ZHH and enter the PeopleSoft project number into the prior authorization AND policy number fields. • If the procedure/visit is NOT covered by the research study’s grant or contract and proper authorizations have been obtained no form needs to be completed and staff should apply the registration to the subject and/or insurance

33. Clinical Trial Management • Should the front desk make a regular chart for the research patient if this patient is only seen by research? How does this impact their account? • Yes if the study involves a clinical intervention. Note that FDA and Good Clinical Practice guidelines require that sites be able to provide original source documents for everyone who participates in a clinical research study. This includes subjects who are seen as normal controls. You need to be able to verify against the chart for auditing and legal purposes. • It should not impact on the subject’s “account” adversely if the appropriate process is followed for clinical trial billing. If there is no funding for the study the visit need not be billed, there are codes in IDX that can be used to keep a bill from being generated.

34. Pharmacy Services for Clinical Trials You should always consult with the appropriate Pharmacy service when evaluating whether to accept a new study that involves a pharmaceutical agent. Facility Pharmacy Contacts: • NSUH Manhasset Leonard Langino, RPh Phone: (516) 562-1588 Fax: (516) 562-1697 Email: llangino@nshs.edu • LIJ James Abberton, RPh or Zina Faynblatt, RPhPhone 1: (718) 470-7423 Phone 2: (718) 470-7430 Fax: (718) 343-824 Email: zfaynbl@lij.edu • SCHNEIDER Richard L. Goldstein, RPh Phone 1: (718) 470-3420 Phone 2: (718) 470-7430 Fax: (718) 343-8244 Email: rgoldste@lij.edu • ZUCKER-HILLSIDEKen Sokol, RPh Phone: (718) 470-8321 Fax: (718) 831-2605 Email: ksokol@lij.edu • Note: If the study will involve other Health System pharmacies, the PI must contact the pharmacy administration of each facility.

35. Pharmacy Services for Clinical Trials How do you reimburse the hospital or satellite pharmacies for services provided in support of clinical research? • If the study has a funding for Pharmacy, monies are transferred via a memo from the PI or Study Coordinator to Finance to transfer the funds from your study specific peoplesoft # to the appropriate Pharmacy Clinical Research Account. • The correct Account # can be obtained by calling Pharmacy Service. If we have a study that covers the cost of a marketed drug that is not provided by the sponsor, can we buy a supply of the drug through the hospital pharmacy department from study funds and then dispense it to the subject as we would for any other study? How would this work? • For marketed drugs the hospital pharmacy can purchase the drug for your study. They can also obtained placebos and other types of pharmaceutical study related items. • Pharmacy will provide you with a quote on cost, they will purchase the medication or supplies and let you know when they have been received. A memo from the PI or Study Coordinator to Finance to transfer the funds from your study specific peoplesoft # to the appropriate Pharmacy Clinical Research Account is all that is required to pay your “bill”. • Medication may need to be stored on site at the pharmacy. • DO NOT ASSUME THIS IS AUTOMATIC: Pharmacy Service may need to negotiate a contract with procurement or allocate space and resources, you must call Pharmacy before the study begins, ideally when the contract with sponsor is being negotiated.

36. Clinical Trial Management Managing Per-Diems, Pick-up Hours, and off shift work: CALL Research Compliance before you consider entering into any of the following. It might be possible but special procedures and in some cases legal contracts need to be put into place. • How do you reimburse another business unit or department within the health system for provision of personnel services as back-up coordinators? What would be the process involved in reimbursing one department for the staff services they have rendered for another department’s patient visit?  • I work part time at 1 health system facility and pick up additional hours by working at another, part or all of my salary is funded by federal grants, what do I need to do? • We have a study coordinator working on collaborative studies where she is actually paid full time by our collaborating site but will be spending 20% of her time at NSLIJ, how do I reimburse the collaborating site for the portion of her salary spent working on NSLIJ activities? • I need a nurse “on call” for a research study that involves after hours enrollment. I’d like to use a nurse from a different clinical department who already works full time as she understands the disease and has agreed to work overtime when needed. This is a federally funded project, how do I budget this, how does her salary get split, and how to I capture effort?

37. Compensation to Research Subjects POLICY • Must be reasonable for the tasks completed, conform to any limitations or exclusions set forth in federal regulations, and not be unduly coercive to study participants. • Protocol specific justifications for compensation should be applied consistently across all study cohorts. • Credit for payment should accrue as the study progresses and not be contingent upon the participant completing an entire study. • Participants should be paid in proportion to their time and inconvenience as a result of participation in a research study. • Unless it creates undue inconvenience or a coercive practice, payment to participants who withdraw from a study may be paid at the time they would have completed the study (or completed a phase of the study) had they not withdrawn. • Information concerning payment, including the amount and schedule should be described in the informed consent document.

38. Compensation to Research Subjects PROCESS • The amount and schedule of all payments should be presented to the IRB at the time of initial review. • The IRB should review both the amount of payment and the proposed method and timing of disbursement to assure that neither are coercive nor present undue influence. • Any alterations in research participant payment must be submitted as a modification to the IRB for approval prior to implementation. • Subjects may be paid through use of petty cash, check requests or gift cards.

39. Subject Compensation and the IRS • Reporting Payments to the IRS • The Internal Revenue Service (IRS) requires that institutions report payments to an individual in excess of $600 per calendar year on Form 1099-Misc. • As a result, Finance will require that the name and social security number of participants be collected on a check request form and released to the Office of Procurement/Accounts Payable for processing, unless a specific request is made not to capture this information due to confidentiality or other study concerns. • The collection and release of this information must be addressed thoroughly in the informed consent document so that it is clear to participants that their identity will be released for the purpose of payment and reporting. • If the study involves sensitive information and/or the amount of compensation provided will not exceed $600 in aggregate during the calendar year, investigators must submit a signed Research Study Participant Payment Form in addition to the Check Request Form

40. Questions about Compensation • How long should it take for the subject to receive their check? • Accounts Payable's standard turn around time on check request processing is 10 business days FROM the time it is received in Accounts Payable.  Those submitting the request should be cognizant of the time it takes for the appropriate approver to approve the check request and also the time in transit from your building to ours (which unfortunately can take two business days.)  If alerted, AP does it's best to expedite requests of an urgent matter.  • Note Research is authorized to use American Express Gift checks to pay for research study subjects.  Controls similar to the way petty cash is handled such as independent accounting, logs and sign offs have to be put in place; however in general it is allowable.

41. Questions about Compensation • Who can we call to check on the status of a check request for subject compensation? • There are queries available in PeopleSoft that most departments use to track the completion of their check requests (AP would be happy to show you), end users can always call the main AP line at 516-396-6430.  • The receptionist will connect the inquiring party to the proper person.  However before doing so, AP respectfully requests that the end user (requestor) factor in the turn around timeline mentioned above.  Inquires prior to considering that only serve to slow down the process overall.

42. Questions about Compensation • If a study subject is also an employee, how do they get paid for doing the study - what is the process? Is it true that the check request process is not used for employees?  • The process for compensating employees and non-employees for research participation is the same • The issue is that IRS rules will definitely be triggered and employee subjects should expect to receive a 1099 for misc. compensation

43. Grant Close Out • PeopleSoft Project IDs will be automatically “turned off” 90 days after a grant or contract period has ended and there is no possibility of renewal • After this 90 day period costs will no longer be allowed to be incurred against a specific project without the review and approval of Grants Financial Reporting

44. Costs Incurred After Close-out • The PI/PM’s Business Unit (ex. LIJ, MANH, FIMR) retains responsibility for costs and liabilities incurred after PeopleSoft Project ID close out. • Charges incurred against an PeopleSoft Project ID after close out will be evaluated by Grants Financial Reporting and will be allocated to the appropriate Business Unit’s operating budget. • Grants Financial Reporting will notify Site Finance when charges are allocated.

45. Process for Special Extension • There may be times when it is appropriate to maintain a PeopleSoft Project ID even though a grant period has ended, for example when an awarded contract for continuation or no cost extension approval is pending or when the award does not have a set expiration date. • A written request to maintain a PeopleSoft Project ID, including project specific justification, must be submitted to OGC or OSP at least 60 days prior to the end of a grant. • OGC or OSP will evaluate each request on a project specific basis in consultation with Grants Financial Reporting. • Grants Financial reporting will notify the PI/PM and Site Finance Director of their decision prior to grant close out.

46. For questions or further information, contact Cyndi HahnAdministrator, Research Compliance516-562-2018