Section 1: Introduction
Section 2: Proposal and Budget Development
Section 3: Managing Awards
Section 4: Travel and Procurement
Section 5 Closing an Award
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.
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.
The Principal Investigator (PI) is responsible for Clinical Trial activities including monitoring monthly financial reports.
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.
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).
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.