Clinical Trials Office

Contracts

Are You a Patient?

Intellectual Property Terms in Research Agreements

Negotiating a clinical trial agreement (CTA)can seem like a daunting task, but the Clinical Trials Office has a dedicated team to represent and usher you through the process. Our goal is to ensure that faculty at USC has access to cutting edge therapeutics and external financial support to conduct innovative research that will both improve the lives of our patients while strengthening our reputation as a research institute. But we need to balance the importance of our policies with the commercial interests of our industry partners.

It is the industry standard amongst academic centers that all inventions made by its employees or contractors are owned by the institution/academic center. This position ensures a certain amount of control in how important new healthcare improvements are introduced to the market. However, when research includes intellectual contributions from our collaborators, we have a process in place to consider these contributions in our handling of IP ownership.

Contracting Procedures

The role of the contract officer, reviews the study ICFs that have been uploaded by the clinical department in OnCore. The contract officer drafts specific ICF language for the Costs, Reimbursement, and Subject Injury Compensation sections to ensure consistency between the final contract/budget and the ICF(s). Then uploads this language into IStar as the initial IRB checklist – at which point the clinical department contact listed in IStar receives an auto-generated email notification.

Once the clinical department receives the IStar auto email notice that the initial IRB checklist has been released, the clinical department must insert the IStar checklist language into the study ICF(s) as a redline (using Track Changes) and then the clinical department must forward those revised ICF(s) to the sponsor for review and approval.

The sponsor then returns their ICF edits or approval to the clinical department, the clinical department must forward that sponsor email and revised ICFs to the CTO for review. Once the three ICF(s) sections are finalized, the contract officer will release a final IRB checklist in IStar, which notifies the department and IRB of the exact Costs, Reimbursement, and Subject Injury Compensation language that has been mutually agreed between USC and sponsor – and that must appear verbatim in the ICF(s).

Docusign

Electronic Signatures Now Accepted by DCG and CTO

Improve processing and study start-up timelines for all research contracting, the DCG and CTO have adopted DocuSign as our electronic signature system. DocuSign is a market leader in e-signature systems. After surveying our sponsors and academic partners, many are using or accept DocuSign as an alternative to their traditional execution process. The expected benefits are:

  • Improving the speed of study start-up.
  • Creating improved visibility into document execution status.
  • Freeing-up resources within CTO and DCG department staff and sponsors by automating a previously paper-based process.

DocuSign is considered to have the highest security, legal enforceability and compliance standards of available signature systems accessible on mobile devices for review and signing of documents. If you have any questions, please contact your DCG Contract Officer or CTO Contract Manager.

Closeup of businessman's hand using pen

Dutch Haas, Contracts Manager, responsible for oversight of the Contracts team.  Dutch and his team negotiate industry-sponsored clinical research contracts and ancillary agreements.  Dutch works closely with clinical department study teams to support the administration of clinical research contracting and assists the Director in special projects, including institution-wide process improvement efforts.

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Denise Deack, Principal Contracts Officer, responsible for review, negotiation and finalization of industry-sponsored clinical research agreements. Denise works closely with clinical department study teams to support the administration of clinical research contracting. She has worked for USC for over 30 years in various capacities and therapeutic areas within the Clinical Trials Office.

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Judy Genovese, Principal Contracts Officer, responsible for initial review and revisions to clinical trial agreements for industy-sponsored trials at USC. Prior to joining CTO in October 2022, she was for 11 years the Sr. Transactions Officer at the USC Stevens Center, advising on intellectual property issues and managing MTAs and CDAs. Before USC, she was at Oracle Corporation, Sun Microsystems and See Beyond Technologies, specializing in intellectual property and contract matters, and was, previous to those positions, general counsel to a software company and anti-trust litigation counsel. She is a graduate of Santa Clara University (Economics) and University of California San Francisco College of Law.

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Amy Christiansen, Principal Contracts Officer, responsible for initial review, negotiation and finalization of industry-sponsored clinical research agreements. Amy works closely with clinical department study teams to support the administration of clinical research contracting.

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LaShonda Rowlett, Senior Contracts Officer, responsible for review, negotiation, and finalization of industry-sponsored clinical research agreements for sponsors USC currently have master agreements in place with. These are typically Work Orders and Statements of Work.  LaShonda also negotiates amendments that are non-budget/protocol related and Confidentiality Agreements. As a team member of the Clinical Trials office, LaShonda works closely with the clinical department study teams to support the administration of clinical research contracting.

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