Investigational Drug Service (IDS) Costs & Fees

Service Center / Biomedical Core

The IDS is a biomedical core and service center of the University of Pennsylvania School of Medicine. Services are not subsidized by either the University, the School or the Health System; rather, the IDS is entirely self-funded through user fees charged to investigators and sponsors.

In compliance with OMB-A21 http://www.whitehouse.gov/omb/circulars/a021/a21_2004.html and University policy 2115 http://www.finance.upenn.edu/vpfinance/fpm/2100/2115.asp, user fees must reflect the actual cost to the IDS of providing services and the IDS must apply these fees equitably to all users. What this means is that the IDS cannot ‘make a profit’ and conversely cannot charge less than its actual costs. By operating right at break-even, providing free services to one investigator or group or one type of study, would result in other investigators and other sponsors effectively covering IDS costs for projects they have nothing to do with, did not review or approve or have any intention of sponsoring. Therefore, the provision of free services is forbidden in OMB-A21.

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Determining Costs for Individual Projects

Because of the complexity of many clinical trials, determining IDS costs often involves an IDS pharmacist reviewing the protocol to determine how much effort is involved. In study startup, for example, effort may be as straightforward as preparing written dispensing procedures (to ensure all IDS staff are following the protocol), attending a study initiation or site evaluation visit, registering the initial drug supply and preparing a prescription blank for the investigator/prescriber to use; for other studies it may involve the preparation of randomization tables, package and label design, development of a blinded dosage form or even assistance in modifying a section of the study protocol. For dispensing activity, costs may vary based on the number of subjects or visits planned for, how much effort is needed at each visit, etc, however there are no ‘up front’ dispensing fees – they are charged along the way as activity takes place.

IDS staff can provide a cost estimate worksheet that spells out what you should include in your study budget or funds request, based on the information provided in your protocol, draft or summary.

An outline of common user fees is included here. Please note that for many of these items there may be a range, or 2-4 tiers, based on complexity. This is complexity in comparison to other clinical trials the IDS is involved with. The more information that is provided up front, the better the IDS pharmacist can determine which fee level applies.

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Determining Costs for Individual Projects

Because of the complexity of many clinical trials, determining IDS costs often involves an IDS pharmacist reviewing the protocol to determine how much effort is involved. In study startup, for example, effort may be as straightforward as preparing written dispensing procedures (to ensure all IDS staff are following the protocol), attending a study initiation or site evaluation visit, registering the initial drug supply and preparing a prescription blank for the investigator/prescriber to use; for other studies it may involve the preparation of randomization tables, package and label design, development of a blinded dosage form or even assistance in modifying a section of the study protocol. For dispensing activity, costs may vary based on the number of subjects or visits planned for, how much effort is needed at each visit, etc, however there are no ‘up front’ dispensing fees – they are charged along the way as activity takes place.

Internal users are defined as investigators affiliated with a UPHS hospital, CPUP practice or any school of the University of Pennsylvania. Internal user fees may also apply to affiliates such as Children’s Hospital of Pennsylvania, the Wistar Institute or the Monell Chemical Senses Center. Please contact an IDS pharmacist if you’re unsure whether your affiliation falls into this category or not.

Lastly, the IDS is required by OMB-A21 and University Policy 2115, to evaluate its user fees at least annually and when necessary, adjust them to maintain break-even. This means that if the IDS makes a ‘profit’ in a year, it may be required to ‘give back’ the excess by reducing its fees to all users. Conversely, if the IDS is operating at a deficit, it must increase fees to all users equitably in order to cover that deficit. As a result, the IDS as a rule does not provide ‘quotes’ or ‘written guarantees’ of pricing, only a cost estimate and guidance for budgeting purposes.

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The Billing Process

The IDS charges user fees on a monthly basis. Startup costs are typically charged at the beginning regardless of whether any subjects are enrolled; these reflect the effort that went into preparing the study prior to any enrollment. Any materials or medications that are purchased, as well as the cost of services such as express mailing, are ‘passed through’ at the time the purchase takes place. Protocol maintenance and inventory management fees are ongoing while the study is active or while a physical inventory is maintained in the IDS. Dispensing, preparation or manufacturing fees are generated at the time that product is dispensed, prepared or manufactured. Study closure fees occur once at the end of a trial – typically around the time of a study closeout visit, or sooner on request – and cover the cost of many years of records archival, as well as the return or destruction of remaining supplies.

For INTERNAL users, a 26-digit university account number should be provided. Fees are compiled electronically at the end of each month and are then uploaded into BEN Financials within about a week. A statement listing the actual costs (including subject initials/ID numbers for dispensing activity), along with the journal entry number, is then emailed (as a .PDF document) to the business administrator on record for that account.

For EXTERNAL users, an invoice is generated and then sent to the business administrator or designee based on the information provided to the IDS at the start of the study. The invoice may be emailed (as a .PDF document) or sent by express mail. The IDS currently is not able to change the frequency of invoicing, but on request may be able to hold invoices and send them out every 2-3 months, as long as there is a track record of prompt payment. For external users, checks should be made payable to Trustees of the University of Pennsylvania and sent to the ITMAT business office; the mailing address is printed on the invoice.

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