Contract Negotiation

Why does it take so long to negotiate contract terms and language in CTA?

After Minimum Documents are submitted within a CT PDRF, your study will be assigned a Clinical Trail Contract Officer (CTCO) to negotiate the CTA terms and language.

Your CTRMG team takes a collaborative approach to negotiating CTAs. With this approach, a successful negotiation upholds Stanford policies, as a nonprofit educational institution, while also partnering with for-profit sponsors. This partnership is grounded on mutually acceptable terms within the CTA.  

It is important to take time necessary to ensure that Stanford’s specific needs are addressed and when necessary to communicate with any third party parties involved in conducting the study. Sometimes an agreement on contractual terms between parties with such different fundamental organizational purposes requires escalation for final approval.

Stanford’s contract requirements differ between company-sponsored trials and investigator-initiated trials.

We take time to ensure we agree on the best possible agreement and strengthen our relationship with sponsor. 

Whenever possible, we encourage sponsors to use the Accelerated Clinical Trials Agreement (ACTA), a Master Agreement with reasonable compromise language that was collaboratively developed by a working group of different stakeholders, including pharmaceutical companies, not-for-profit organizations, and academic research institutions. Use of this standardized agreement greatly expedites the contracting process.

Many industry sponsors prefer to use their own CTA template and when it does not comply with Stanford’s institutional requirements, negotiation on the contract’s terms and conditions is required.

Stanford currently has over 100 Master Agreements in place with pharmaceutical, device and biotechnology companies and use of these existing agreements also greatly expedites the negotiation process.

There are 6 key areas of concern that often require negotiation and may delay contract execution: intellectual property, study data, indemnification, subject injury, confidentiality, and publication rights. Reimbursement procedures are also often addressed within the contract terms.

Some investigational device studies require Stanford Hospital to negotiate a Purchase Agreement with the sponsor. Please refer to hospital website link in Resources section for the online form to initiate this agreement.