Costs & Fees
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.
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.