UB's Clinical Research Office supports investigators and their teams to create, establish, and manage trials that advance human health outcomes.
The CRO helps investigators navigate the complex "onboarding" process for new trials to ensure they are compliant and financially viable. The workflow for all human subjects research, including clinical trials, must begin with a centralized registration and compliance review.
Central Study Registration (CSR):
The investigator submits basic study information, which acts as a "triage" step.
The Clinical Research Office (CRO) uses the information from the CSR to assess the study's needs, assign support, and create the initial submission within the compliance systems.
Protocol Development & Budget:
The CRO or Office of Clinical Trial Development and Implementation (OCTDI) assists with budget development and negotiating with industry sponsors, which includes creating a Coverage Analysis (determining which costs are standard care vs. research costs) to ensure billing compliance.
This phase focuses on institutional and regulatory approvals, which must be completed before the study can enroll participants.
Contracts & Agreements (SUNY RF Role):
The Office of Sponsored Projects (OSP), acting under the SUNY RF, negotiates the Clinical Trial Agreement (CTA) with the external sponsor (e.g., pharmaceutical company).
Any necessary Non-Disclosure Agreements (NDAs) or Material Transfer Agreements (MTAs) are finalized here.
Regulatory Guidance:
Providing expertise on IRB submissions, as well as Investigational New Drug (IND) and Investigational Device Exemption (IDE) applications.
IRB Submission & Approval:
The study is submitted to the Institutional Review Board (IRB) via the electronic Click system.
The Office of Research Compliance (ORC) manages the IRB process, which includes:
Conflict of Interest (COI) review.
Pre-review by Clinical Research Facilitators to ensure completeness.
Full Board, Expedited, or Exempt review based on risk.
OnCore Registration:
The study is registered in OnCore, the Enterprise Clinical Trial Management System (CTMS), a centralized system used to track protocols, manage subject enrollment, and streamline financial billing. This is critical for study management, financial tracking, and regulatory compliance.
Once all approvals are secured and the study is active, the CRO provides the infrastructure and tools necessary to maintain high-quality data and participant safety.
Clinical Research Center (CRC): A dedicated outpatient facility located at 875 Ellicott Street. It offers:
Participant Recruitment: Assistance is provided by the CTSI Clinical Recruitment Coordinator to develop and implement recruitment strategies and promotional materials.
Clinical Services: Procedures, visits, and sample collection often occur at the Clinical and Translational Research Center (CTRC).
Data Management: Data is collected, managed, and monitored, utilizing systems like REDCap and OnCore.
Regulatory Maintenance: The study team is responsible for ongoing submissions to the IRB (e.g., Continuing Review, Amendments, Adverse Event reporting).
Training & Professional Development
The CRO is heavily involved in building the clinical research workforce at UB through structured educational programs.
Study Closure: The protocol is completed, participants are discharged from the trial, and final documents are submitted to the IRB and sponsor.
Dissemination: Results are published, which includes the regulatory requirement to register results on ClinicalTrials.gov.