Salary Expense Transers
  • PARS-Administrator or Designate to prepare the necessary paperwork to move salary expenses to or from a clinical study
  • OES will need to receive a PAR 15 calendar days before the monthly Pay Compute date to be process in the month of submission
  • A cost transfer justification form is needed for expense transfers over 60, 90, or 120 days, re-transfers any age (Unrestricted to C&G as a place holder), transfers to closed funds (Only allowed within the applicable award period). Please keep in mind that these types of transfers are subject to EFM approval and put the project at a higher audit risk and for this reason, the signed justifications are sent to our EFM accountants for record keeping
    *Transfers involving finance/unrestricted require a justification at all times
  • Clinical study overdrafts will be closely monitored by the assigned fund manager. Please remove all salary prior to the contract end date
  • Fund manager will prepare the payroll expense transfer in the UCLA online system


Transfer of Funds
  • Please obtain your PI’s written approval, dollar amount, why the transfer is being made, and list to whom the TOF is intended. Forward this information to your fund manager for processing
  • Fund manager will prepare the TOF in the UCLA online system


NPEAR Transfers
  • A cost transfer justification form is needed to move any expenses from a clinical study. Transfers must be processed prior to 120 days from ledger date
  • Fund manager will prepare the NPEAR using the transfer to fund and justification form in the UCLA online system


Applicable Expenses
  • The only charges allowed on a clinical study are those listed in the contract approved budget
  • Office supplies are strictly monitored by our EFM accounts and must be listed within the approved budget for use as a project specific office supply on clinical studies. If these items are not within the budget, please use an unrestricted funding source to purchase these items


Invoicing
  • The Administrator is to prepare an invoice in accordance with the terms of the contract. For example, the contract may read upon completion of ECRFs, at 30 days, at 90 days, after monitoring, etc…
  • Please note, payments for clinical study are earned after we enroll patients. We do not receive funds upfront for the entire project. When at all possible, we will ask for start-up costs to help offset some of our starting salaries and other project expenses
  • Please remember to invoice annually for renewals that are within the contract
  • Please remember to invoice for items on your invoiceable tab that were completed in the current invoice cycle
  • The PI is ultimately responsible for the oversight of this project and any budgetary shortfalls


Calculations
  • Please submit your active patient list and invoiceables to your fund manager regularly
  • Kindly include your fund manager on all invoice requests
  • Fund manager will keep an internal tracking sheet logging the number of patients, invoices, and payments received
  • In the event payment is not issues within the terms of the agreement, your fund manager will request that either the Administrator or PI contact the Sponsor directly to make payment arrangements. After two follow-ups by the Administrator, the fund manager will request that the PI initiate contact on payment matters


Statements
  • Your assigned fund manager will run your monthly financial summaries and summary of funds
  • In the event your project runs in an overdraft, your fund manager will meet to discuss your options. Please note, the PI is responsible for covering any overdrafts as a result of running the clinical study. To close a project out, the fund must be >$0
  • Once completed, reports are uploaded for Department review


Reimbursements
  • Unless specified in the project budget, travel for the PI and Staff is not typically covered as a clinical study expense
  • In some cases, parking for patients will be covered in the project budget as a line item or invoiceable


Overdraft report
  • Each month, a deficit report is run and submitted by OES and submitted for processing to the fund manager by assigned PI
  • The fund manager will analyze the balance due, how to resolve the deficit, and action items taken to clear the deficit should be noted on the template. Your fund manager will contact you for an action plan in the event of a future projected or actual overdraft
  • Your fund manager will make updates to the comments section on how the team will clear the overdraft each month. Justification and action items should change regularly until the overdraft is resolved. If an overdraft cannot be resolved, please notify your fund manager immediately
  • Once complete, the report is compiled and submitted electronically for Department review


Closures
  • Administrators, please submit the necessary paperwork to move all project expenses to alternate funding sources. Expenses, such as salary, will continue to hit until the necessary paperwork is submitted to move the payroll
  • b) In the event expenses and payroll are after the end date, Fund Manager to move salaries or NPEARs using the steps indicated above in the pre-award close out
  • All open encumbrances must be closed. EFM will not close out the project until all expenses are cleared
  • Fund Manager to complete Rapid closeout tool (Transitioning to PAMS) or PAMS
  • Fund manager to pull the award synopsis from the fund binder or ORA Portal
  • Administrators, please obtain HS-8 from either the Regulatory Coordinator
  • Administrator, please obtain a closure letter or E-mail from Sponsor/Regulatory, an E-mail confirming closures
  • Administrators, please work with your fund manager PI Closure letter. When possible, please spend down below 25% of the award amount received prior to the award end date
  • Fund manager to provide a final calculation or accounting for the project
  • Fund manager to run the PPP Ledger in QDB under the Other UPAYs tab
  • Fund manager to run the General Ledger in QDB under Detail closed
  • Study Folder is pulled from the cabinet as part of the COP and prepared for storage
  • Once all documents are routed and signed, SMART Closeout tool is used through the ORA Portal. The required documents are the certification, COP, and back up documentation
  • EFM sends a written notification confirming fund closure
  • Fund Manager requests that the account is ”Y” out
  • Recharge ID is closed
  • Once closed, the documents are archived


Clinical Study Contract Amendments-Examples requiring a contract amendment
  • Additional invoiceables
  • Changes to the protocol that either increase or decrease the per patient budget
  • The addition of cohorts for another disease site
  • Change in PI
  • Change in Sponsor
  • Change in study title
  • Award end date is reached and study has not been completed (Requires a formal amendment from the Sponsor).
  • The addition of a CRO
  • In any case where the per patient budget costs change, the pre-award process will start anew, which includes coverage analysis and budget negotiations with the Sponsor


No Cost Time Extension
  • These can be requested only if the contract does not require a firm end date
  • Based on the current IRB approval
  • There is no restriction on the number of times, so long as there is no firm end date, project is still collecting data or recruiting, and the IRB approval is current