Clinical Research Office (CRO)

Doctor with Patient.
Public Disclosure of Clinical Trials Information
Human Subjects Research and COVID-19


Guidance for the Continuation of Human Subjects Studies with Regard to COVID-19

Guidance for Human Subjects Research

FDA Guidance during COVID-19 Pandemic

Mission

The UB Clinical Research Office (CRO) is a centralized office charged with administrative oversight for all clinical research activities of the university's faculty members. The CRO facilitates compliant, meaningful research within the institution by unifying policies governing research conduct across all university schools and departments.

On this page:

Central Study Registration
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Billing Compliance in CRMS
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Clinical Research Office Services

  • Contracts
    7/21/17
    Contract negotiation is the process by which two or more parties establish the legal parameters of an agreement.  
  • Budget Development
    6/27/17
    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.
  • Protocol Development
    6/27/17
    In preparing for submission to the Institutional Review Board (IRB), faculty members consult with the CRO staff for protocol development and to review their clinical research studies for operational feasibility.
  • Pharmacy
    4/27/23
    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.
  • Regulatory Assistance
    8/5/24
    Clinical investigators initiating a drug or device study invoke a number of specific regulatory requirements for protection of human subjects in clinical trials.

Clinical Research Defined

Clinical Research

Patient-oriented research. Research conducted with human subjects (or on material of human origin such as tissues, specimens and cognitive phenomena) for which an investigator (or colleague) directly interacts with human subjects. 

Excluded: In-vitro studies which use human tissues that cannot be linked to a living individual. 

  1. Patient-oriented research includes:
    • Mechanisms of human disease
    • Therapeutic interventions
    • Clinical trials
    • Development of new technologies
  2. Epidemiologic and behavioral studies
  3. Outcomes research and health services research

Clinical Trials

A research study in which one or more human subjects are prospectively assigned to one or more interventions (which may include placebo or other control) to evaluate the effects of those interventions on health-related biomedical or behavioral outcomes.

Contact Information

Sanjay Sethi, MD
Medical Director
(716) 888-4864
ssethi@buffalo.edu

Pamela Anderson RN, BSN
Associate Operational Director
(716) 888-4841
pka2@buffalo.edu

Kimberly Brunton RN, MSN
Associate Operational Director
(716) 888-4840
kbrunton@buffalo.edu

Staff Directory