A clinical trial is defined by NIH as "a research study in which one or more human subjects are prospectively assigned to one or more interventions (which may include placebo or other control) to evaluate the effects of those interventions on health-related biomedical or behavioral outcomes" (NIH definition). Wayne State University (WSU) faculty and staff participate in numerous clinical trial projects to study investigated drugs or devices.

Such studies may be conducted under an industry-developed protocol or an investigator-developed protocol. These studies are most often conducted in conjunction with obtaining new drug or device approval from the U.S. Food and Drug Administration (FDA), under Phase I, II, III, or IV (testing phases). Although they can be designed with the sole purpose of collecting and analyzing data about approved drugs or devices in contribution to medical knowledge about the treatment of a disease or medical condition.

These studies are usually funded by pharmaceutical companies and are an important part of the process to assure the safety and efficacy of the drug or device, obtain FDA approval, and bring a product to market.

Sponsored Program Administration (SPA) is responsible for reviewing, negotiating, and legally executing contracts from external funding sources. The resolution of many contractual issues requires coordination between the external funding source, Investigator, and SPA; the involvement of each party is essential to a successful contractual arrangement with mutually acceptable terms.

What is SPA's Procedure for Processing Corporate Sponsored Clinical Trials?

The SPA Contract Team is responsible for processing all incoming Clinical Trial Agreements for the University. The following procedure ensures timely and efficient processing of these contracts. This procedure outlines the responsibilities of the PI and/or Administrator, and SPA during the submission and negotiation processes.

1. Administrator and/or PI enters a complete proposal into Cayuse including the following attachments
   1. Clinical Trial Checklist
   2. Clinical Trial Agreement (CTA)
   3. Affirmation Memo for Research Agreements completed and signed by the PI
   4. Sponsor Budget
   5. Protocol
   6. Sponsor contact information
2. Once received, the SPA Contract Team will review the complete proposal and send the contract and affirmation memo to the Office of General Counsel (OGC) within two business days. The PI and/or Administrator will be kept apprised of any issues with the proposal.
   1. If the contract is NOT APPROVED by OGC:
      1. SPA will handle all negotiations. SPA will email the sponsor with the requested changes. The PI and/or Administrator will be copied on the correspondence with the sponsor.
      2. When sponsor response is received, SPA will review the contract, with input from the PI or Administrator if necessary, and return updated contract to OGC for review. If the contract has additional changes, SPA will continue the negotiation process until an approved contract is received
   2. If the contract is APPROVED by OGC and:
      1. The proposal is complete - SPA will request and obtain the necessary signatures and mail the contract to the sponsor. A copy of the contract will be emailed to the PI and/or Administrator.
      2. The proposal is not complete - SPA will contact the PI and Administrator informing what is still needed. Once the proposal is complete, SPA will request and obtain the necessary signatures and mail the contract to the sponsor. A copy of the contract will be emailed to the PI and/or Administrator.
3. Once the University has signed the contract, and any necessary IRB approvals and Informed Consent Forms have been obtained, the SPA Contract Team will route the proposal to the cognizant SPA Grant and Contract Officer for index/account establishment.
4. The index number and fully executed contract will be sent to Pharmaseek Financial Services (PFS) for billing purposes (this does not apply to contracts with federal or nonprofit flow-through or those that do not require invoicing).

Additional Notes

During the contract negotiation process, the PI and study team should proceed with other required startup activities, including developing and negotiating the study budget, submission to the IRB, and, if the study will be taking place with the Detroit Medical Center, submission to the DMC Clinical & Translation Research Office. While SPA can negotiate a clinical trial agreement prior to receivng these approvals, the clinical trial cannot commence until the IRB approves the protocol, the contract has been fully executed, and DMC approval (if applicable) has been received.