Industry Sponsored Clinical Trials

Responsibilities

OSR negotiates all clinical trial agreements and amendments, established clinical trial accounts in the University financial system, and works closely with Accounting Services for Research and Sponsored Programs (ASRSP) on account close outs. The Northwestern Center for Clinical Research (NCCR), which was established to enhance and facilitate clinical research activities, is available to help with such things as budget preparation, recruitment efforts, and quality assurance reviews.

Clinical Trial Materials 

Components of a complete clinical trial package include: a fully executed agreement, final approved protocol and consent form, IRB approval letter, sponsor budget which includes 26 percent indirect cost, and a completed and signed OSR-CT form (revised 3/99). This new form is a streamlined version of the traditional OSR-1 proposal routing form, geared specifically to industry sponsored clinical trials. The OSR-CT incorporates several unique features, such a section for pre-spending requests. All of the aforementioned components plus either a pre-spending departmental guarantee or an initial check from the sponsor must be in place before an account can be established in the University financial system.

Contract Negotiations 

OSR will begin contract negotiations prior to receipt of all the required components referenced above. However, critical elements to begin the process include a completed OSR-CT form, draft agreement, sponsor budget, study protocol, and consent form. Incomplete packets will be returned to the PI. Please note that the amount of time needed to finalize an agreement when it is necessary to negotiate proposed terms and conditions varies greatly, depending on the number of changes needed, the complexity of the issues, and the availability of the negotiators. PIs should ensure that OSR receives all required paperwork well in advance of projected start dates in order to allow time for negotiations. On particularly problematic issues, OSR may need to coordinate with University’s legal department and/or risk management department.

Common contact terms which must be modified through a negotiation process include but are not limited to: inadequate indemnification and liability provisions, stringent and over-reaching confidentiality requirements, burdensome records retention and notification requirements, one sided or financially risky termination provisions, overly restrictive publications clauses, far-reaching intellectual property clauses, insurance issues, noncompetition mandates, and injunctive relief clauses. If changes are made to the study that may impact contractual terms and conditions (i.e., change of PI, extension of time, enrollment of additional subjects, etc.) contact OSR at 312/503-7955.

PI Initiated Studies 

Please notify OSR if the project is PI-initiated. If the PI is initiating and coordinating a multicenter study, OSR should be involved in a preliminary meeting with the PI and the PI’s project coordinator in order to facilitate and coordinate the process and to begin drafting subcontracts specific to the project.

Financial Account

When OSR sets up an industry sponsored clinical trials accounting in the financial system , the standard object codes listed on the OSR-CT instruction sheet will be opened. If additional objects are needed they must be indicated on the new OSR-CT form. The appropriation reflects cumulative revenue received to date. Please note that the direct cost appropriation will be allocated to object 2900 and indirect cost to object 8710. Direct cost expenditures should not be posted to object 2900, but rather to objects that are appropriate for the types of expenditures incurred.

To facilitate the orderly completion of clinical studies, OSR will automatically extend the study end date (if one is designated in the contract) in the financial system account by one year, PIs should notify ASRSP so the account can be closed.

Nonrefundable Start-Up Costs 

If a project is terminated early, OSR will attempt to recover reasonable start-up costs in addition to earned expenses. PIs discuss the need for nonrefundable start-up costs in their initial interactions with sponsors so that this condition may more easily be incorporated into the final contract.