Clinical Research Office (CRO)

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:

Clinical Research Office Services

6/27/17
Contract negotiation is the process by which two or more parties establish the legal parameters of an agreement.  
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.
6/27/17
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.
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.
6/27/17
Designing a study forces you to clarify your concepts and develop a goal. While challenging to consider all aspects of the process, the CRO can guide you, ensuring that you create a clinical trial with relevant and reportable outcomes.

National Institutes of Health (NIH) definitions

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
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