Services

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 trial 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 

A successful clinical trial will include a budget that meets the financial needs of the institution for conducting the trial. OCT collaboration and processing begin with a review of your protocol’s visit schedule. This review, done with the PI and sponsor, is required to determine which procedures are considered “research” and which are considered “standard of care” as part of a formal coverage analysis.

The investigator and the research team are intimately involved with the budgetary process. We examine all budgetary planning and proposed charges and fees prior to execution of the Clinical Trial Agreement (CTA) to ensure competitive and adequate reimbursement for trial work and patient needs, as well as inclusion of appropriate fees and overhead. OCT oversees the process to be sure planned expenses include appropriate costs for tests and procedures, hospitalizations, equipment, staffing, IRB fees, storage and institutional overhead. We help you identify the proper charges for each of these fees, which include but are not limited to Clinical Research Center (CRC) fees, startup fees, pharmacy and radiology fees, and study site activation charges.

The Office of Clinical Trials utilizes an Internet-based CTMS system (VELOS) to track and account for the studies that we oversee. This system allows our office to record study information, store and organize electronic documents, track patient visits, manage budgets, finances, invoices and receivables. Study Coordinators, Division Administrators, and Investigators also use this software to assist them with the patient management of their clinical trials. 

The Office of Clinical Trials (OCT) provides financial management for research costs associated with all studies managed by our office via Velos CTMS. OCT financial management includes monthly patient/study activity invoicing, tracking receivables, monitoring holdback, milestone processing, collections, payment processing, and reconciliation and reporting.

Epic will handle standard of care billing to the patient or third party.

The Office of Clinical Trials (OCT) is committed to the promotion of clinical research education and training. OCT has developed several projects aimed at enhancing the skills and professional development of clinical research personnel at Montefiore-Einstein. Our program development goals include increasing the quality of clinical research conduct and streamlining research processes across the institution.

Please see below for a description of our ongoing initiatives and programs coming through the pipeline:

• Training Opportunities
  • Lunch & Learn: A monthly series where clinical research personnel can gather informally to learn about and discuss topics related to clinical research operations at Montefiore-Einstein and enjoy a complimentary lunch. Each session features a presentation and discussion led by a knowledgeable and experienced member of Montefiore-Einstein’s research community.
   
• Resources
• Clinical Research Guidelines: A comprehensive document intended to guide personnel on conducting clinical research at Montefiore Medical Center. The guidelines include an overview of types of clinical research, research administrative offices, institutional, local, state, and federal regulations, and useful templates aimed at standardizing study conduct and documentation.
• E-Learning Modules via Talent Management: The OCT is working closely with Montefiore’s Learning Network to develop clinical research e-learning modules to be housed in Montefiore’s Talent Management System. Clinical Research Personnel will be able to access online modules to receive training on utilizing specific research systems, engaging particular research administrative offices, among other lessons. Personnel will be able to access these modules from their desktops and even revisit the modules after completion as a refresher if necessary.
• Distribution List: Our distribution list provides us with a quick and easy way to share information about educational initiatives, updates, and opportunities for professional development. If you would like to be added to our distribution list, please email carmrod@montefiore.org 
    

 

Recruitment and enrollment of volunteers has been identified as the single biggest obstacle impacting the ultimate success or failure of a clinical trial. The Office of Clinical Trials offers an array of advertising tools to facilitate subject accrual: 

• Internal advertising on E-Screens, campus newsletters (e.g., Montefiore Update) and print materials (flyers, brochures, posters, cards) 
• External promotion of studies including print and radio ads and bus shelter and newsstand ads 
• Digital registries and recruitment platforms (e.g., ResearchMatch, CenterWatch, trial listing services, vendor websites)
• Provide educational patient brochures (English and Spanish) for dissemination
  English Brochure
  Spanish Brochure 
• Recruitment Template for Social Media

Montefiore Marketing and Communications provides advertising development and production support services for a number of the resources described below. Marketing will help to develop, and in accordance with institutional policy, must provide approval for all study materials which include Montefiore-Einstein branding. Advertising materials generated by the Sponsor/CRO which do not have Montefiore-Einstein branding do not require approval by Montefiore Marketing. 

Turnaround times: Marketing requests 2-4 weeks for the development and/or review and approval of all advertising materials (4-6 weeks is requested for brochures). E-Screen messaging will be posted within 1 week following submission of approved message.

Remember to include all planned recruitment methods in your IRB application and to obtain IRB and Sponsor/CRO approval for all advertisements and amendments. The Einstein IRB advertising policy can be accessed here. Please note, IRB approval of the advertising medium and associated messaging is required for all community-facing clinical trial advertising materials.

To learn more about the recruitment resources available or to schedule recruitment consultation, please contact Office of Clinical Trials.

Additional Recruitment Advertising Resources

Investigators conducting clinical trial research are required to use the Greenphire ClinCard program to reimburse their research subjects for their study participation. ClinCard is a web based, reloadable, debit card that automates reimbursements based on the approved ICF and study budget. With protected usernames and passwords, study teams are able to process payments on the day of a subject’s visit.

Employing this Web-based system will:

• Reduce paperwork and processing time for dispensed funds
• Increase subject retention and compliance
• Improve patient satisfaction
• Centralize reporting, tracking and auditing of stipends and reimbursements

Please refer to the Office of Clinical Trials Greenphire Policy for guidance

Complete our Greenphire Application and submit to the Greenphire administrator to get started

Office of Research Sponsored Programs (ORSP) manages government-funded research including sub-awards granted to Montefiore Medical Center;

Biomedical Research Alliance of New York (BRANY) for Montefiore Industry-Sponsored clinical research;

Office of Grants Support for federally funded research including sub-awards granted to Albert Einstein College of Medicine;