The Office of Clinical Trials (OCT) manages, negotiates, and finalizes private (non-government) research agreements between sponsor and investigator. Legal counsel is available within OCT and attends to all investigator research and team legal requirements. A contract defines the scope of work, states the understanding between the parties, contains legal and financial terms related to the conduct of the research, and ultimately serves to protect the rights of the investigator and Institution.
When is a research agreement required?
An agreement is required when there is an exchange of any sorts with an external party.
Agreement execution
Investigators may not contractually bind the Institution to a research agreement. However, most agreements do require that the investigator acknowledge that they have reviewed the agreement, and agree to its terms and conditions. The Office of Clinical Trials will not sign an agreement on behalf of the Institution until the Investigator has signed.
Timeline
OCT strives to review, negotiate, and execute agreements within 30-90 days.
Common contracting issues
- Publication rights
- Indemnification
- Subject Injury
- Insurance
- Intellectual property and invention rights
- Publicity and use of name
- Study Conduct
- Termination and Survival
- Governing law, Jurisdiction and Arbitration
- Foreign Laws
Types of agreements:
Confidentiality Agreements (CDA or NDA) ensure the confidentiality or “secrecy” of information that one party discloses to another party. A fully executed (signed by all parties) CDA enables the parties to explore the potential research collaboration.
Clinical Trial/Research Agreements (CTA or CRA) are legally binding agreements, typically with an industry or other non-profit sponsor, which manage the relationship between parties and define clinical research projects, budgets, and terms and conditions affecting publication, indemnification, insurance, intellectual property, data rights, confidentiality, and financial support.
Master Agreements define most but not all of the terms with sponsors who intend on working with the Institution on future clinical research endeavors. Its purpose is to simplify and expedite upcoming research projects.
Work Orders are study-specific agreements (addendums) that incorporate the terms of the Master Agreement and set forth the conditions that are unique to the particular study, such as budget/payment terms, schedule details, protocol name, and principal investigator.
Amendments (Supplements, extensions and modifications) are modifications to the original agreement.
Service Agreements (Lab services; Software, Consulting) are agreements in which the Institution is performing a service for hire. These agreements are only appropriate for projects that do not involve any basic or applied research.
Submission Montefiore Einstein has fully implemented the use of Velos, which is a web-based Clinical Trial and Research Management System (CTRMS). Agreements handled by the Office of Clinical Trials are managed in Velos. In an effort to ensure a seamless submission, please visit this step-by-step guide which demonstrates how to submit to the Office of Clinical Trial via Velos. If additional assistance is needed or questions arise please contact Velos Help, veloshelp@montefiore.org
