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Office of Sponsored Projects
a) Monthly account reconciliation:
For best practices, it is expected that the department manager will reconcile
accounts with the billing plan at least every 30 to 45 days. Accurately
charged expenses on clinical trials will depend on adequate budget preparation
and understanding the charge-capture processes and systems. The
department manager should develop procedures and tools to support correct
expense charging and subsequent proper invoicing.
Communication is the key to account reconciliation. The PI should be
kept informed of expenses and balances. OSP should also be informed of
the status of the account, the milestones that have been met, and expected
payments.
Here are some helpful financial management hints for reconciling:
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- Are all charged expenses appropriate?
- Have professional fees been charged to the study account?
- Is all supporting documentation available?
- Have all charges been posted?
- Have all payments been received? If not, the department manager
should follow-up with the sponsor for payments.
- Have all variable and/or additional costs been
invoiced?
If the clinical trial account is over/under budget, the department manager
will determine the cause. The department manager will review the contract
for payment terms and compare to enrolled subject count to date. Unpaid
invoices will then be discussed with the sponsor to determine if the sponsor’s
financial obligation can be met.
b) Invoicing & Payment:
Each department manager should create an invoicing system capable of tracking
billing, including all up front non-negotiable fees, and payments
received. For these particular invoices,the OSP Sponsored Research
Manager should be notified of criteria completion and that payment is
forthcoming. Generally, payment is submitted by the sponsor after receipt of an
invoice, a case report form, or on regularly set
intervals as outlined in the contract.
As per the agreement, checks for OSP clinical trials should be mailed
to:
Trustees of Dartmouth College
Office of Sponsored Projects
11 Rope Ferry Road, HB 6210
Hanover, NH 03755-1404
Clinical trials are unique in that payments are
based on established milestones such as patient enrollment or tasks
completed. Payments are made by sponsor upon review of completed case
report forms (CRFs).
Unlike other sponsored projects, the clinical
trial budgets are not entered into the financial accounting system(FAS) at the
beginning of the trial. This is done as checks are received. The
department manager should work with the OSP Sponsored Research Manager on the
budget breakdown for payments.
c) Clinical Trial Close Out:
Before a clinical trial account can be closed out, the department manager will
review the account to verify that all appropriate expenses have been charged
per the Billing Plan.
The PI will submit a signed close out memo to the OSP Sponsored Research
Manager certifying that all expenditures/obligations related to the project
have been finalized.
If there is a residual balance, the PI will need to submit an explanation to
the OSP Sponsored Research Manager. The existence of residual funds may
indicate services not billed, unpaid invoices,or expenses billed
inappropriately to another payer.
If diligent review indicates appropriate charges have been submitted, the
OSP Sponsored Research Manager will be notified and in turn will review the
terms and conditions of the agreement for handling of the residual
balance. In some cases, the clinical trial agreement may reference that
all unused funds will need to be returned to the Sponsor. The OSP
Sponsored Research Manager will carefully review the clinical agreement for
such clauses before approval is authorized for residual funds then may be moved
to a research reserve account.
Hitchcock Foundation
The Hitchcock Foundation does not require a formal signed close out memo
from the PI. The PI needs to submit an email request, verifying that the
trial has closed, that all obligations under the agreement have been fulfilled
and funds will be moved to an Advised Fund for future research or educational
expenses.
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