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
    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
    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
    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
    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
    Contract negotiation is the process by which two or more parties establish the legal parameters of an agreement.  
  • Coverage Analysis
    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
    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
    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
    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
    11/29/22 is a worldwide registry and results database of publicly and privately supported clinical studies with human participants.
  • Working with the Clinical Research Center
    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.
  • Working with ECMC as an affiliate
    As a public benefit corporation and affiliate of UB, ECMC recognizes that its first responsibility is to the health and well being of the research subjects.
  • Working with Kaleida Health as an affiliate
    If you require access to Kaleida Health (KH) electronic medical records or will be conducting study related procedures within KH, you must contact Kaleida's Office of Research and Sponsored Projects. This does not apply if you are employed directly by Kaleida Health.
  • Community Engagement
    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
    Clinical investigators initiating a drug or device study invoke a number of specific regulatory requirements for protection of human subjects in clinical trials.