Clinical Trial Agreement
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.
How the Contract is used for Study Set-up
The CTA provides critical information for Study Set-up by confirming the for-profit status of the sponsor. The for-profit status along with the scope of work allows CT RMG to classify the study as an industry-sponsored clinical trial.
Once the CT RMG Intake Team receives and reviews all Minimum Documents, the CT RMG Intake Team assigns a CT CO to negotiate the terms and conditions of the contract. Stanford University delegates authority to the CT COs allowing them to negotiate and sign agreements on behalf of the institution. Researchers, principal investigators, staff, and other members of study teams do not have authority to sign contracts on behalf of the University and such agreements are not enforceable.
Who negotiates contracts for industry sponsored clinical trials?
CT COs in RMG negotiate most contracts required for the conduct of industry sponsored clinical trial agreements:
- Nondisclosure Agreements
- Clinical Trial Agreements
- Clinical Material Agreements
- Clinical Trial-related Agreements
- Clinical Trial-related Subcontract
The CTA will not include any procurement terms for investigational devices. These studies require a separate contract between the Hospital and the sponsor. Use the Stanford Health Care (SHC) Contract Administration department’s online form to initiate the procurement contract. SHC and the Lucile Packard Children’s Hospital (LPCH) utilize the services provided by the Contract Administration Team.
For industry sponsored projects that do not meet the clinical trial criteria, please contact your Research Process Manager (RPM) to determine next steps.