Clinical Trials Contracts negotiates industry-funded clinical trial agreements for the health system.

Clinical trial agreements handled in this office have all the following characteristics:

  • They always involve Prospective testing in Human Subjects and always require Institutional Review Board (IRB) review (this does not include cadaver or animal studies, nor does it include retrospective chart reviews)
  • They examine the Efficacy, Safety or Benefits of a Food and Drug Administration (FDA) reviewed Medical Intervention involving a Drug, Device, Treatment or Diagnostic (this would typically not include studies which involve the effects of beverages, foods or exercise on health, for example)
  • They are fully funded, directly or indirectly, by a For-Profit Entity (agreements which are partially or fully funded by non-profit, state or federal entities cannot be reviewed by this office)

For the purposes of qualifying for the clinical trial indirect cost rate exception, the definition of a clinical trial is here.

Research agreements which do not meet all of the criteria above will be handled by the Office of Research Sponsored Programs Office.

Clinical Trials Contracts negotiates confidentiality agreements and service agreements directly related to industry funded Clinical Trial Agreements.

Clinical Trials Contracts has staff that can assist with budget development; however, clinical trial budget development and budget negotiation with the Sponsor of a Clinical Trial is ultimately a department responsibility.