Clinical Research Workflows Federally Funded Clinical Research DOM Workflow Research projects that receive federal funding are administratively managed at the college. The Einstein Division Administrators within the Department of Medicine are available to assist our investigators prepare and submit grant applications. Below is a high level overview of what you can expect during the start-up process for federally funded research. Identify funding opportunity The Office of Grants Support (OGS) provides assistance with identifying sources of funding, and shares information on Funding Opportunity Announcements (FOA) via their website and newsletter. Contact your Einstein Division Administrator Discuss the details of the grant or funding opportunity with your Division Administrator, who will work with you to prepare your grant application in Cayuse, our institutional platform for submitting grant applications. Develop budget and justification Work with your division administrator to craft a detailed budget and justification. If your project involves clinical procedures or costs that will be incurred at Montefiore Medical Center, ensure the Office of Clinical Trials (OCT) is added to the Cayuse routing chain for review. Finalize your research plan/protocol Visit the Office of Grant Support (OGS) website for resources including sample grant applications to help finalize your research plan. Complete and submit grant application in Cayuse Provide Division Administrator with final documents to upload in Cayuse. Once the Authorized Organizational Representative (AOR) has approved the application in Cayuse, the Division Administrator can submit to Grants.gov and other non-federal sponsors. Notice of Award (NOA) The application is reviewed by funding source. If accepted, Notice of Award (NOA) is received. Fund is established by Research Finance. Foundation Funded Clinical Research DOM Workflow Coming Soon Industry Funded Clinical Research DOM Workflow Industry-funded clinical research start-up within the Department of Medicine requires the coordination of the efforts of several stakeholders, including the Principal Investigator, Division Administrator and Chief, Department Vice-Chair, the Office of Clinical Trials, and the Biomedical Research Alliance of New York (BRANY). There are two routes for initiating an industry-funded clinical research study depending on whether the study is industry or investigator-initiated. All industry funded projects require departmental approval via the Request to Initiate an Industry Sponsored Project in Human Subjects form. Industry-Initiated Start-up Process (BRANY Studies) Confidentiality Disclosure Agreement (CDA) Industry sponsor sends Confidentiality Disclosure Agreement (CDA) to the PI in order to share the industry protocol with the PI for review. Investigators should not negotiate nor sign their own CDAs. Submit CDA to BRANY for review, negotiation and execution BRANY negotiates all contracts for industry-initiated clinical research protocols, including CDAs. Investigators should submit the draft CDA to Eileen Summers, Medicine Relationship Manager at esummers@brany.com. Protocol Feasibility Review Once the CDA is fully executed, the sponsor will send the protocol to the PI. The PI should thoroughly review the protocol for feasibility. PIs should also discuss the research plan with applicable Montefiore Ancillary Departments (Pathology, Radiology, Pharmacy, etc.) to understand operational, logistical and financial requirements of collaboration. Submit ISP Form for Division and Department Approval Complete the Request to Initiate Industry Sponsored Projects in Human Subjects (ISP Form) in order to obtain Division and Department approval to initiate contract negotiations and IRB submission for the study. Submit ISP Approved ISP Form to BRANY Email the PDF copy of the approved ISP Form to the Medicine BRANY Relationship Manager, Eileen Summers as esummers@brany.com. Provide BRANY with any pertinent study documents you may have received from sponsor (i.e. draft Clinical Trial Agreement (CTA), draft budget, study protocol, etc.). BRANY Negotiates CTA with Sponsor; Performs IRB Review BRANY will review and negotiate the Clinical Trial Agreement (CTA) with the sponsor. Protocol and other study materials undergo IRB review. PI and study coordinator update the BRANY SMART and IRB Manager systems as needed per BRANY guidance. Fully Executed CTA and IRB Approval; Sponsor Site Initiation Visit Once the CTA has been executed and the protocol and study documents have received IRB approval, study teams can schedule the Site Initiation Visit (SIV) with the sponsor. Download PDF Version Investigator-Initiated Start-up Process (OCT Studies) Preliminary synopsis of project or PI interest in industry grant opportunity PI of investigator-initiated study discusses protocol synopsis with industry partner to gauge interest, as applicable. PIs should not share final protocol with any external party until a Confidentiality Disclosure Agreement (CDA)/Non-Disclosure Agreement (NDA) has been executed. Contact the Office of Clinical Trials (OCT) to establish a CDA The Office of Clinical Trials (OCT) helps establish and negotiate CDAs for investigator-initiated studies involving industry funding. Contact OCT at OCT@montefiore.org to get started. CDA Negotiation and Execution PIs should communicate with OCT to address any questions or concerns. CDA is fully executed and investigator-initiated protocol is shared with industry party. Discuss Feasibility and Logistics PI should discuss the research plan with applicable Montefiore Ancillary Departments (Pathology, Radiology, Pharmacy, etc.) to understand operational, logistical and financial requirements of collaboration. Submit ISP Form for Division and Department Approval Once industry partner agrees to collaborate, PI should submit a Request to Initiate Industry Sponsored Projects in Human Subjects (ISP Form) in order to obtain Division and Department approval to proceed with IRB submission and contract negotiations for the study. Initiate iRIS application PI submits study to iRIS for Einstein IRB review. Indicate the OCT will be involved in the management of this project. Failure to add OCT in iRIS will result in contractual delays. IRB and OCT will work in tandem -do not wait for Final IRB approval before completing next step... Velos notification received Follow instructions on Velos notification email. Upload protocol, approved ISP Form and other relevant study documents to Velos Attachments and follow steps on OCT Checklist. Failure to complete Velos and OCT steps will result in delays in contract negotiation OCT negotiates contract with external party; IRB reviews study PI should communicate with OCT to address any budgetary or contractual concerns; address any IRB stipulations in iRIS. Fully executed contract and IRB Approval Once the agreement has been executed and the protocol and study documents have received IRB approval, PI can commence study activity. Download PDF Version
