Clinical Trials Financial Management for Sponsored Programs

Background

New York University (NYU) scientists are engaged in a wide variety of clinical trials, investigating new approaches to preventing and treating conditions and diseases.  A variety of areas are studied, ranging from new pharmaceutical drugs and medical devices to behavioral and biotechnology therapies. These trials are done in close collaboration with scientists, dentists, and physicians from many areas of expertise across NYU.

NYU Approach

It is the policy of New York University that all clinical trials shall be performed in accordance with generally accepted standards of good clinical practice, in compliance with the protocol and with all applicable local, state and Federal laws and regulations governing the performance of clinical investigations.

Financial Management

The Principal Investigator (PI) is responsible for Clinical Trial activities including monitoring monthly financial reports.

^ top of page

Invoicing and Payments to Participants

The department tracks milestones and performs timely billing of study activities for the appropriate Clinical Trial. The department must submit all invoices to SPA for review and approval prior to submission to the Sponsor. The department also coordinates appropriate and timely payments to participants.

^ top of page

Documentation for Human Research Participant Protection

The PI and Department Administrator (DA) should ensure that all personnel involved in the research project have met training requirements. The PI and DA are also required to maintain documentation of compliance with training requirements. For assistance meeting these requirements, please contact your Project Officer in the Office of Sponsored Programs (OSP).

^ top of page

Project Closeout

The PI and DA should monitor deadlines to ensure timely submission of required documents to federal agencies and other sponsors. Study documentation must be maintained according to sponsor requirements and University policies and procedures.

^ top of page

Related Training