Clinical Trial Agreement (CTA)

The Clinical Trial Agreement (CTA) is one of the Minimum Documents required for the CT RMG Intake Team to set up a study.  After negotiation and signature, the CTA legally binds the Sponsor and Stanford to the agreed-upon terms and conditions, including a payment schedule for the clinical trial. All CTAs must conform to Stanford policies on research found in the Research Policy Handbook.

The PI or study team submits a copy of the sponsor’s CTA template to CT RMG. If the sponsor does not provide a CTA template, the PI or study team notifies CT RMG Intake Team so that the Clinical Trial Contract Officer (CT CO) can send Stanford’s preferred template to the sponsor to initiate negotiations.

Stanford encourages the use of the Accelerated Clinical Trial Agreement (ACTA), a Master Agreement developed by a working group of stakeholders, including pharmaceutical companies, not-for-profit organizations, and research institutions.  Use of ACTA is preferred because it greatly reduces contract negotiation time, and provides reasonable compromise language for various stakeholders.