Definition of a Clinical Trial

DEFINITION A CLINICAL TRIAL
Industry-Sponsored Clinical Trials: Clinical trials are a subset of clinical research and must include ALL THREE of the following factors in order to qualify for the clinical trial indirect cost rate:

1. The objective of the study is either:
a. Testing of drugs, devices, diagnostics, treatments, interventions, or preventive measures including testing for an unapproved indication; or
b. Data collection to increase knowledge that would lead to enhanced safety and efficacy of a specified drug or device; and

2. The study must involve contact with humans or retrospective review of medical records, clinical data or specimens obtained from contact with humans;

3. The study must be industry sponsored or funded.

IF YOUR TRIAL DOES NOT MEET THESE CRITERIA
For Industry Sponsored, Non-Clinical Trial Research, go to the Office of the Industrial Liaison (OIL) website. OIL manages all activities relating to industry sponsored research projects, other than trials meeting these criteria, in addition to the protection and commercial promotion of inventions at New York University.

For Grants (other than Industry Sponsored Grants), go to the Office of Sponsored Programs Administration (SPA) website. SPA provides support and assistance with non-industry grant and research proposals, including budget development and sponsor compliance review for funded research.