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