Pass-thru items will be negotiated. The sponsor will be asked to
identify and include a separate line-item for each of these costs,
such as, initial set-up and IRB fees associated with each study.
The contract includes the necessary indemnification language
whereby the sponsor assumes liability for the study and indemnifies
Swedish for performing this work for them. Other important items are
ensuring that the sponsor will allow for indirect costs and
reimburse for study related injury.
When Contract Negotiation is complete, the contract is signed by
management of Swedish as well as the Sponsor. When the budget is
finalized, it is given to the Principal Investigator. At that time,
we also check to ensure that up front IRB and Set-Up Fees have been
billed to the Sponsor.