FDA Guidance
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Office of Clinical Trials (OCT)

Getting Started

To begin the process of activating a clinical research study, you must utilize the Velos Clinical Research Management System (CRMS) and adhere to the associated study workflow. The Velos CRMS streamlines, integrates and manages all clinical research activities at Montefiore-Einstein. The system ensures regulatory compliance, improves quality of data, and streamlines 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. 

If you are a first time user, please contact veloshelp@montefiore.org to request a User Access Form, and follow the necessary steps for study management. You can access the Velos site here. 


Research Study Start-up Process

This flowchart outlines the overall process for starting-up a clinical trial at Montefiore-Einstein. The steps may vary depending on the type of study, and the funding source. However, this flowchart captures the general steps required to go from study concept to activation.

Research Study Start-up Process - Flowchart


Upcoming Events

Lunch & Learn: Postponed Until Further Notice   





The Montefiore Einstein Office of Clinical Trials 

Montefiore Medical Center
111 East 210th Street
Moses Research Tower, 8th Floor, Room 8-014

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