Clinical Trial/Study Agreement

Definition

• A clinical trial agreement (CTA) or clinical study agreement (CSA) is a legally binding agreement that governs the conduct of a particular study and sets forth the obligations of each party to the agreement. Parties to clinical trial or study agreements include the participating site, the study sponsor, and/or the relevant clinical research organization (CRO).

Policies/guidelines

• CTAs and CSAs are processed by the Office of Clinical Trials (OCT). The assigned OCT contract and budget negotiator will facilitate review by all relevant UMMC departments and offices and signature by the OCT Director.
• CTAs and CSAs are not signed until the contract and budget are approved and UMMC IRB approval is confirmed via UMMC’s internal routing system, called Radar.
• The bullet points below illustrate the CTA/CSA process for industry-sponsored clinical research studies:
  • OCT negotatiator reviews and revises the agreement, which is uploaded to an electronic contract routing system (3 business days)
  • Office of Intellectual Property and Commercialization, Office of General Counsel, Office of Integrity and Compliance, Division of Information Systems, and Office of Information Security review and revise the agreement (15 business days)
  • OCT negotiator compiles changes and sends CTA/CSA response to sponsor or CRO (3 business days)
  • OCT negotiates the CTA/CSA with the sponsor or CRO until finalization (2 business days per party, not to exceed 30 calendar days)