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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) 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.    
 

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 

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

Marketing publishes a bi-weekly digital and print newsletter (Montefiore Update) with a regular column dedicated to clinical research activities being conducted across the Montefiore Health System. To feature your study in an upcoming issue of Monte Update please contact the Office of Clinical Trials. You may request a layout template to help guide you with crafting your message. Please limit messaging to no greater than 90-110 words. Your trial will be placed in the Newsletter queue as dedicated space in Update is limited.  

Would having your study presented on digital displays at Montefiore or at Einstein be of interest to you as a medium for conveying the important research your team is conducting? If so, perhaps placement of your study on a campus E-Screen is the answer. To feature your study on a Montefiore or Einstein E-Screen please contact the Office of Clinical Trials. A layout template can be provided for E-Screens as well. As with Montefiore Update, please limit messaging to no greater than 90-110 words for all Montefiore E-Screens. Availability for Einstein E-Screens is limited; however, consideration will be given for studies for which the Einstein E-Screen is an appropriate medium.

Did you know that the Office of Clinical Trials maintains a selection of bus shelter space (including digital ad space) within the Bronx? If your study team would be interested in marketing your trial on one of these reserved spaces, please contact the Office of Clinical Trials at oct@montefiore.org. Information about the process, including teaming up with Marketing and Communications to develop an ad campaign, will be shared. 

The following local print publications may be invaluable to help message your clinical trial to our community. Please contact the organization for current rates and specific advertising options. Remember that rates posted on the website may be negotiable.

Norwood News: Bi-weekly publication (advertisement stays in publication for 14d). Print and online (Digital and Classified Advertorials) advertising options. Also, option for including inserts in print copies.

Point of Contact:
David Cruz
Office: 718-324-4998; Cell: 914-698-6216
dcruz@norwoodnews.org 

The Bronx Free Press / Manhattan Times: The community’s bilingual newspaper. Published every Thursday. Print and online (Digital Classified Ads and Banner Ads) advertising options. Color options available. No additional charges for standard ad design.  

Point of Contact:
Debralee Santos
212-569-5800
sales@thebronxfreepress.com 

 

The Bronx Times: 3 editions, covering different regions of the Bronx, all of which are published every Thursday. Print and Online (Website and Digital Classified Ads) advertising options.  

Point of Contact:
Donna: 917-969-4734
Display: 718-260-4593; Classifieds: 718-260-2500
dmsalesbxtimes@aol.com 

Riverdale Press: Broadsheet (layout similar to the NY Times) print edition published every Thursday. Print (color option available) and Online advertising options. Sold via subscription at newsstands. Graphic artist on staff at no additional charge.  

Point of Contact:
Cheryl Ortiz
718-543-6065 (x379)
cortiz@riverdalepress.com 

 

Bronx Penny Pincher: Print edition published every Thursday. Einstein/Montefiore standard 10% discount. Volume discounts available. Print (color copy) and Online (website and digital classified) advertising options.  

Point of Contact:
Steve Aaron
718-828-1104
bxpp@aol.com 

New York Times: Assorted advertising options within Newspaper, Magazine, Digital or T platforms Media Kit Specs 

Media Kit - Select category for rates 

New York Daily News: Advertising options across a variety of digital and print platforms  
Media Kit 

 

AM New York: Print and digital publication with a circulation of 1.3 million which targets a younger demographic and provides news across all boroughs. Available at high-traffic transit and tourist locations and delivered free to commuters via street teams and distribution boxes. To view media kit and customizable specs:  

Point of Contact:
Janice Padilla
631-843-3603
Media Kit 

Village Voice: The nation’s first alternative newsweekly the Village Voice can tailor advertising in their digital publication (desk-top or mobile w/1.1 million monthly uniques) or a banner ad in one of their six weekly digital newsletters.  

Point of Contact:
Perry Tripp
212-475-8473

 

The Bronx Mall: The Bronx has 12 community boards that meet monthly to discuss items of concern to the community. The Board Meetings are open to the public. Such a venue would provide an opportunity to interact with members of the local Community and share the value of your research. 

Montefiore Medical Center’s main campus is within the border of Community Board 7:  

229A 204th Street
Bronx, NY 10458
TEL: (718) 933-5650
cb7@bronxmall.com 

The Albert Einstein College of Medicine is within the border of Community Board 11: 

1741 Colden Avenue
Bronx, NY 10462
TEL: (718) 892-6262 
cb7@bronxmall.com 

 

The Bronx Chamber of Commerce: The COC provides a wealth of information and public outreach opportunities. The website offers a Community Events Calendar highlighting local events (perhaps setting up a booth or kiosk?) as well as the Bronx Business Directory to enhance opportunities for engagement. Contact Sashee Rivera or 718-828-3900 for more information. 

Mosholu Montefiore Community Center: A vital community resource which provides support services to area children, adults and senior citizens through enrichment, education and recreation programs. WOW! Creative Group publishes an e-newsletter on behalf of MMCC. A hyperlink to a study website or other informational source about your trial may be submitted for inclusion in their e-newsletter. If interested, please contact Wayne Brown

 

Co-op City Community Relations Department: IRB-approved study materials (e.g., flyers, posters) can be emailed to Michele Sajous. Once approved by the Co-op City community board, the community relations department will post study materials on bulletin boards (free of charge) across Co-Op City buildings and community centers based on available space. For more information, please contact the Community Relations Department at 718-320-3300 (x3532). The Community Relations Department also publishes a weekly Saturday newspaper distributed throughout Co-op city. For information regarding advertising options within the publication please contact Rozaan Boone.

 

Trials whose ‘Status’ is listed as ‘Active/Enrolling’ in the Velos CTMS will be uploaded to the Montefiore Clinical Trials Database. If revisions or updates to existing information need to be made contact the Office of Clinical Trials

CenterWatch hosts one of the largest online databases of clinical trials actively seeking patients. You can post descriptions of your IRB-approved studies that prospective participants may search by medical condition, therapeutic area and location. If you would like to list your trial on the CenterWatch website, please complete the data elements in the appended form and email the completed form to Ilija AtanasovskiCenterWatch Template  

ResearchMatch is a free, secure, online, disease-agnostic, registry and recruitment tool which connects people who are trying to find research studies and clinical trials with researchers who are looking for volunteers. Researchers (i.e., Investigators, coordinators, or designated recruiters by proxy) can join ResearchMatch by executing the following steps (it is important to note that a Researcher MUST register themselves prior to being able to register a study): Register Here  

A Spanish language version of ResearchMatch has recently launched. For more information about the Spanish language version please contact your institutional ResearchMatch liaison.

If you have questions regarding any of these available recruitment resources, please contact the Office of Clinical Trials.

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

January 23 | 12:00 pm - 1:00 pm   

Lunch & Learn: ClinicalTrials.gov - Registration and Reporting 

 

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 

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