oct 1
oct 2
oct 3
  •  
  •  
  •  

Office of Clinical Trials (OCT)

  Services

OCT is committed to serving the needs of our principal investigators and their study coordinators as well as study sponsors interested in conducting clinical trials at Montefiore/Einstein by offering:

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.

Data Use Agreements (DUA) allow the exchange of a limited data set as defined by HIPAA for the purpose of furthering research. A DUA ensures appropriate treatment of the exchanged data under the privacy laws.

Material Transfer Agreements (MTA) govern the exchange of patented and non-patented biological and non-biological material. Similar to a DUA, the MTA ensures appropriate treatment of the exchange.

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.

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 (MERGE) 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 Merge 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) may provide experienced study coordinators to investigators conducting clinical trial research at Montefiore-Einstein. Study coordinators, provided by the OCT, may provisionally assist the investigator with the following activities:

  • Regulatory binder documentation preparation and maintenance, and IRB submissions: deviations, amendments, site monitoring visits, continuing review
  • Data management
  • Recruitment/retention of subjects and overall protocol adherence and execution and (putting participants through the protocol)
  • Liaise between sponsor and institution
  • Ensure Investigators’ and collaborators’ COI and CITI requirements are up to date

Please refer to the Office of Clinical Trials Study Coordinator Support Policy for more information.

Use the Study Coordinator Request Form to get started.

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.
    • Navigating Clinical Research Course: An annual 1-day, in-person course intended to orient personnel in clinical research practice, policies, and procedures at Montefiore -Einstein. The course will expose personnel to the major clinical research administrative offices, and walk them through what they can expect when conducting research at Montefiore. Navigating Clinical Research is recommended for Investigators, Study Coordinators, Regulatory Coordinators, Research Administrators, and more.
     
  • 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.
    • Research Listservs: Our research listservs provide a quick and easy way to communicate with a community of research personnel with a broad range of experience, ask for advice or help with questions about managing clinical research studies, and share information about educational initiatives, and opportunities for professional development.

      We encourage Research Coordinators, Assistants, Nurses, and Technologists to join our Research Coordinator listserv and complete the short subscription form with your e-mail address and a password.

      We encourage Investigators, Research Fellows, and Administrators to join our Clinical Investigators listserv and complete the short subscription form with your e-mail address and a password.
     
 

One major challenge of clinical trials is the recruitment and enrollment of subjects. The Office of Clinical Trials is aware of this challenge and offers numerous recruitment strategies and tools to facilitate subject accrual and assist study teams.

An OCT Recruitment Specialist works with the Investigator and study team to evaluate the study recruitment needs, develop a recruitment plan, and assists in implementing the recruitment plan to promote the study and disseminate information to other practitioners at Montefiore and Einstein

Recruitment Services Include: 

  • Development of a recruitment plan
  • Assistance in implementation of the recruitment plan
  • Provide educational patient brochures (English and Spanish) to disseminate
    English Brochure
    Spanish Brochure  
  • Assist in developing flyers, brochures, and study advertising material (radio, newspaper, bus shelter ads)
  • Internal advertising on hospital E-screens and in the Monte-Update Newsletter
  • External promotion of studies through radio, newspaper and bus shelter ads

To learn more about the recruitment resources available or to schedule recruitment consultation, please contact OCT@montefiore.org 

Recruitment Resources 

Montefiore Clinical Trial Database 

To list your study on the Montefiore Clinical Trial Database, www.montefiore.org/clinicaltrials contact the Office of Clinical Trials at OCT@montefiore.org.

Research Match 

ResearchMatch is a free national registry bringing together volunteers wanting to take part in research with investigators conducting studies. To learn how you can use ResearchMatch for your study, visit https://www.researchmatch.org/ or contact your Montefiore/Einstein institutional liaison at ilija.atanasovski@einstein.yu.edu. Monthly ResearchMatch webinar training is available to researchers and coordinators. Click here to register for an upcoming training session.

CenterWatch 

CenterWatch is a clinical trial database providing clinical trial information to patients. To post your study free of charge on the CenterWatch Montefiore/Einstein page, contact Ilija Atanasovski at ilija.atanasovski@einstein.yu.edu.

Research Subject Recruitment 

Click here for recruitment tips and strategies.

 

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;

Upcoming Events

April 19 | 12:00 PM   

Lunch & Learn: The Informed Consent Process 

May 23 | 12:00 PM   

Lunch & Learn: INDs and Clinicaltrials.gov Registration 

 

Contact

The Montefiore Einstein Office of Clinical Trials 

Montefiore Medical Center
111 East 210th Street
Moses Research Tower, 8th Floor, Room 8-014
718-920-2000
OCT@montefiore.org 

Click here to log in