Office of Research Administration

Clinical Trials

What is a clinical trial?

NEW! Checklist for Applicable Clinical Trial - PLEASE READ

Effective April 18, 2017, the FDA and NIH have expanded their regulations and policies for the governance of Clinical Trials.

A clinical trial is a prospective, biomedical or behavioral research study of human subjects that is designed to answer specific questions about biomedical or behavioral interventions (drugs, vaccines, biologics, treatments, medical devices, or new ways of using known drugs, vaccines, biologics, treatments or medical devices). Behavioral interventions are intended to prevent or treat an acute or chronic disease or condition.

Clinical trials are used to determine whether new biomedical or behavioral interventions are safe, efficacious and effective. There are four phases of clinical trials and each phase is designed to answer a specific and separate research question.

Phase I
To test a new drug or treatment in a small group (20-80) of people for the first time to evaluate its safety; determine a safe dosage range; and identify side effects.
Phase II
To test the drug or treatment in a larger group (100-300) of people to see if it is effective and to further evaluate its safety.
Phase III
The drug or treatment is given to large groups (1,000-3,000) of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments and collect information that will allow the drug or treatment to be used safely.
Phase IV
These studies are done after the drug or treatment has been marketed to gather information on the effect in various populations and determine what, if any, side effects are associated with long-term use.

There are several central offices on campus that will assist you in preparing and running a clinical trial:

  • Office of Research Administration (Pre- and Post-Award divisions)
  • Research Pharmacy
  • Institutional Review Board
  • Technology Office

The Pre-Award Division will assist with the review, negotiation and execution of confidential disclosure agreements (CDAs) and non-disclosure agreements (NDAs). They will assist in the preparation of investigational device exemptions (IDEs) and investigational new drug applications (INDs). In conjunction with RFC, they will negotiate your clinical trial agreements (CTAs) and provide assistance and consultation with budget preparation. They will interact and communicate with sponsors, clinical research organizations (CROs) and other entities on behalf of the institution, researchers and departments on issues related to clinical trials.

The Post-Award Division will establish a business process for invoicing and the collection of revenues based on the executed clinical research agreement. Any invoices that do not require case report forms (CRFs) will be prepared and processed by post award staff. Post award will work with the study coordinator to record and follow up on the receivable generated by CRFs that are required to secure payment.

The Research Pharmacy will store and provide drug preparation for your clinical trials and follow all sponsor and federal requirements in regards to dispensing and destroying medications.

The Institutional Review Board is responsible for reviewing and approving all IRB protocol submissions.

The Office of Technology Transfer provides assistance as it relates to inventions, intellectual property rights and ownership.

Please don't hesitate to contact any of the offices noted above if you have any inquiries regarding their roles in clinical trials at Downstate and any assistance they can provide in getting your clinical trial up and running.


Sharon Levine-Sealy, Director of Pre-Award Operations

Elliot Feder, Director, Post-Award Research Administration

Kevin L. Nellis, MS, CIP, Executive Director
Human Research Protection & Quality Assurance

HELPFUL LINKS: is a registry and results database of publicly and privately supported clinical studies of human participants conducted around the world.

Clinical Trials and Human Subject Protection at the U.S. Food and Drug Administration.

NIH Clinical Research Trials and You – National Institutes of Health (NIH)