Contract Negotiation

Reach out at any time to the CTCO assigned to your study.  Your scheduled KO meeting is an ideal time to bring up any questions you may have regarding the CTA. If not yet determined, at this meeting the CTCO will confirm the following details:

• Was PI involved in writing the protocol?
• Will any intellectual property arise from conducting the study?
• Does the PI have any financial disclosures to be considered?

Who signs the CTA?

Principal Investigator as Signatory. As a PI, you are not party to the CTA since you will be performing the agreement solely in your capacity as a Stanford employee.  However, PIs sign the CTA to attest that they have read and understood its terms and their obligations and responsibilities. A PI does not have authority to sign a CTA on behalf of Stanford.

1. Intellectual Property (IP) Rights

IP Rights refer to patents and other intellectual property rights in inventions. Stanford does not include copyrights in the category of IP rights that may be assigned to sponsors by CTA. While Stanford employees are required to assign rights to patentable inventions to the university all rights in copyright remain with the creator and thus, Stanford cannot assign to sponsor rights that it does not have.

2. Study Data

CTA should include terms to allow PI

• access to final study data and analysis for data from all sites
• retain a copy of Stanford generated data to document the research & provide patient care
• to publish Stanford data

3. Indemnification

When a sponsor- initiated study involves a drug or device, the sponsor must indemnify, defend and hold harmless all Stanford affiliated parties from and against all claims, liability, damage, loss or expense arising from conducting the study that are not due to Stanford’s negligence or willful failure to follow the protocol.

For example, sponsor must cover claims arising from subject injury or illness caused by the investigational product according to the protocol. Also, claims from the sponsor’s use of study data and any IP rights granted to the sponsor must be covered.  For investigator-initiated studies, the sponsor’s liability for these claims is restricted to areas the sponsor is responsible for (e.g. manufacture of the product or use of study data).

4. Subject Injury

When a sponsor- initiated study involves a drug or device, the sponsor must agree to provide funding to cover medical care costs for any study related injury or illness. As a general policy, the sponsor’s subject injury obligation should cover a subject’s medical care costs regardless of whether these costs are covered by the subject’s insurance. Stanford does not agree to bill a subject’s insurance for injuries sustained in connection with an industry-sponsored clinical trial.

For investigator-initiated studies (IIS), Stanford will cover subject injury medical costs and the CTAs are reviewed by Stanford’s Risk Assessment Committee (RAC) so that the financial risk to Stanford may be assessed. If the risk is determined to be too high, RAC may not allow study to proceed.  

5. Sponsor’s Confidential Information

Sponsors may require confidentiality of sponsor-provided information and study terms and may request that the data generated by the study be treated as confidential information for purposes other than academic publication. Due to Stanford’s openness in research policies, neither the existence of the CTA nor the identity of the study may be confidential. Stanford should have the right to disclose the confidential information as needed, to review, conduct and oversee the study, to adhere to applicable regulations and to assure appropriate medical care of study subjects.

6. Publication Rights

As an educational and research institution, Stanford’s basic mission is the discovery and publication of new ideas and technologies.  CTA must provide for the right to publish and present research results. As part of Stanford’s commitment to openness in research, Stanford does not agree to let sponsors keep study results confidential, prevent their publication, or “hide” bad results.

1. Insurance Coverage

Sponsors are expected to maintain, through study period and for a reasonable period after study has ended, a level of insurance (defined by Stanford IRB’s determined risk level of the study) to cover their financial obligations under the CTA.

2. Use of Stanford Name

Sponsor must agree not to use Stanford name or logo in press releases, marketing or any other promotional documents without Stanford’s prior review and written approval.

3. Restrictions to conducting research

CTA may not restrict Stanford from engaging in other research. For example, with the assumption that this is clearly discussed in the informed consent, investigators should be able to collect, retain and use tissue specimens from study subjects for research unrelated to the study and the investigational drug or device being tested.