Feasibility Form
This tool can be used by Principal Investigators (PI), Chairs and Administrators to assess a proposed trial in terms of subject and resource availability, staff workload, financial impact, competing trials, and ancillary collaborations. By evaluating the resources needed to conduct a successful clinical trial prior to the initiation of the process, the PI ensures that logistical issues are identified and addressed upfront, thereby reducing delays in the protocol activation timeline.
Feasibility Form
Greenphire
Greenphire-Clincard is a web-based payment system that enables research subjects to be compensated for their time, travel and expenses. PIs and study coordinators are able to process reimbursements included in a study budget on the day of a subject’s visit.
Designated study team members must complete the Greenphire-Clincard e-Learning module prior to using the reimbursement system for their studies. Access the e-learning module.
Please review the Office of Clinical Trials Greenphire Policy for guidance. Contact the OCT Greenphire administrator for more information. Greenphire Application 2021
Velos
Montefiore and Einstein implemented Velos as an Enterprise Clinical Research Management System to streamline, integrate and manage all clinical trial and research activities. The Velos system will provide an exciting opportunity to standardize operations and manage research related activities and ultimately reduce workload by linking many disparate systems currently utilized for research management, eliminating duplicative work. The system will improve quality of data, ensure regulatory compliance, and streamline administrative and financial management of the studies, sponsors, and patients by providing comprehensive protocol management, patient recruitment, coordination and calendaring, regulatory reporting, adverse event management and reporting, quality assurance reporting, and consolidated invoicing and financial management. Velos interfaces with EPIC@Montefiore and with both IRB systems currently in use by Einstein and Montefiore investigators (Einstein IRB and BRANY IRB) to implement seamless workflows for all study personnel.
In order to ensure that regulatory reporting requirements are met, utilization of the Velos system is required for all human subject research conducted at Montefiore Einstein. The Velos system, the associated Standard Operating Procedures (SOPs) that have been developed as part of the implementation, and the planned interfaces with other systems, have been designed to meet compliance requirements while streamlining staff activities wherever possible.
VELOS ACCESS
Epic and Velos training is now a joint class. To request access for Velos/ EPIC training, please visit the Montefiore Self-service portal, select EPIC > Register for an Epic Class > Complete form. If you do not have access to the portal, call the Montefiore IT Help Desk +1 (914) 881-4554 for assistance and instructions.
PI's Only
If you have completed EPIC training, Click Here to View Velos Online Training Video and Self-Certify.
If you have NOT completed EPIC training and require access to Velos, please follow the instructions above.
If you have any questions, contact support at Veloshelp@montefiore.org.
Step-by-step guide
Complion
In an effort to continue our mission to improve the probability of success in Montefiore Medical Center clinical trials, the Office of Clinical Trials has implemented the use of the Complion e-Regulatory System, an electronic regulatory binder, for New Industry Sponsored and Investigator Initiated Clinical Trials managed by OCT and BRANY.
The Complion e-Regulatory System offers a documentation and workflow solution that replaces the hybrid paper system for the clinical trial regulatory compliance process, where some files are stored electronically in shared/network drives, while other file copies are kept in paper format in regulatory binders. By providing a venue where all regulatory documents are stored securely, research staff now have a streamlined and efficient system that will ensure regulatory compliance.
