University at Buffalo (UB)
The State University
of New York
University at Buffalo (UB)
Clinical Research Office
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Set Up Study

The Clinical Research Office helps faculty and researchers in setting up studies and clinical trials to optimize resources and meet all regulatory requirements. 

  • Confidential Disclosure or Non-Disclosure Agreements
    9/14/26
    The Confidential Disclosure Agreement (CDA) or Non-Disclosure Agreement (NDA) are basically the same. They denote an agreement between two or more parties to protect the exchange of confidential information
  • Clinical Research Initiation and Maintenance Costs
    9/14/26
    There are several start-up fees when you initiate a clinical trial. These vary depending on the design of the study. Below, we have defined the fees and identifed the responsible parties.
  • Budget Development
    9/14/26
    A budget is the schedule identifying the charges to be assessed to a funding entity for conduct of a clinical research study based on the protocol-defined work to be completed.
  • Clinical Trial Agreement
    9/14/26
    A Clinical Trial Agreement (CTA), Clinical Study Agreement or Clinical Research Agreement are all names for an agreement or contract between the university and another party relating to the conduct of a clinical trial or study.
  • Contract Negotiation
    9/14/26
    Contract negotiation is the process by which two or more parties establish the legal parameters of an agreement.  
  • Coverage Analysis
    9/14/26
    Coverage Analysis (CA) allows us to do a systematic, objective review of study related documents to determine which items or services are billable and to whom: the insurer; sponsor or patient.  
  • Humanitarian Use Device
    9/14/26
    A Humanitarian Use Device (HUD) is a medical device intended to benefit patients in the treatment or diagnosis of a disease or condition that affects or is manifested in fewer than 4,000 individuals in the United States per year.
  • Investigational Device Exemption
    9/14/26
    An Investigational Device Exemption (IDE) allows an investigational device to be used in a clinical study in order to collect safety and effectiveness data required to support a Premarket Approval (PMA) application or a Premarket Notification [510(k)] submission to Food and Drug Administration (FDA).
  • Investigational New Drug
    9/14/26
    An Investigational New Drug (IND) is a drug or biological drug that has not been approved for general use by the FDA. It is used in a clinical trial to investigate its safety and efficacy.
  • Registration on Clinical Trials
    9/14/26
    ClinicalTrials.gov is a worldwide registry and results database of publicly and privately supported clinical studies with human participants.
  • Trial Registration in CRMS
    9/17/26
    The CRMS (Clinical Research Management System) is the current online system for central study registration at UB. OnCore is replacing it.
  • Working with the Clinical Research Center
    9/14/26
    UB's Clinical Research Center (CRC) is a fully equipped center offering a wide range of services for investigators and staff who conduct clinical studies. The Center is located at 875 Ellicott Street, Buffalo, NY 14201.
  • Community Engagement
    9/14/26
    Community engagement means working collaboratively with people and groups affiliated by geography and special or similar interests to address issues affecting the well-being of those people.
  • Regulatory Assistance
    9/14/26
    Clinical investigators initiating a drug or device study invoke a number of specific regulatory requirements for protection of human subjects in clinical trials.

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