Services and Resources

Research facilitators, regulatory assistance personnel, and recruitment specialists assist in linking researchers with the right support services and resources for proposal development and project execution.

Research Facilitation

Research facilitators assist in linking researchers with the right support services for proposal development and project execution. The facilitation process can be initiated after an initial contact through the CTSI's service request portal, a visit to the Clinical and Translational Research Center (CTRC), a personal contact, an email or a phone call.

The facilitators triage the movement of studies through the university research systems and can arrange consultations and services with any of the CTSI cores. (See CTSI Cores tab.)

Regulatory Assistance

The CTSI clinical research regulatory administrator provides regulatory assistance guidance. Support includes working directly with the investigator, the sponsor, and (if needed) the Institutional Review Board (IRB) to accurately complete the necessary forms for IRB submission, ensuring adherence with national regulatory and institutional requirements and helping to eliminate potential bottlenecks and costly delays.

The CTSI regulatory administrator and quality assurance specialist guide research teams on registering studies in ClinicalTrials.gov. Detailed information including FAQs and a "ClinicalTrials.gov Registration Guide" are available for investigators and their research teams. For further information on ClinicalTrials.gov, click here.

Recruitment Assistance

Participant recruitment can pose a challenge for clinical trial teams. The single greatest obstacle to performing clinical research is recruiting people to participate in clinical trials. We assist researchers across the Buffalo Translational Consortium in preparing and implementing successful recruitment strategies, with a special emphasis on recruiting underrepresented and special populations. The clinical recruitment coordinator works with study teams to develop and implement novel recruitment strategies, including initial consultations and assistance with developing promotional materials. The online Recruitment Resources Toolkit provides methods to enhance recruitment for research studies.

We are the point-of-entry for researchers seeking assistance from the Clinical and Translational Institute (CTSI). We can put an investigator in touch with the right CTSI cores, or you can access directly via the CTSI service request portal.

Clinical Research Office

The UB Clinical Research Office (CRO) is a centralized office responsible for 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.

CRO services include recommendations/referrals and consultations on the following:

The Clinical Research Center (CRC) is a fully equipped outpatient suite which includes seven examination rooms for investigators and staff who conduct clinical studies. The CRC is located on the sixth floor of the CTRC building at 875 Ellicott Street in Buffalo.

Services offered by highly trained and certified personnel within the CRC include: assessment of vital signs; electrocardiogram; phlebotomy services, including pharmacokinetic and pharmacodynamic sampling; local laboratory processing of biological samples for results and laboratory processing for central lab shipment; intravenous line placement and maintenance; urine collection and urine pregnancy testing; investigational drug administration and post administration monitoring; investigational drug storage and accountability; participant interviews and administration of study questionnaires; basic nutritional services; short-term storage of frozen specimens in preparation for shipment to a central laboratory facility, and pharmacy.

Institutional Review Board (IRB)

We conduct pre-reviews of IRB submissions in order to advise on proper use of templates; package submission requirements; section-by-section guidance on completion of a protocol (503 or 508) and consent; and navigating through Click IRB.

QA/QI Self-assessment Tool

Individuals planning quality assurance/quality improvement (QA/QI) projects can complete the “QA/QI Self-assessment Tool” and receive instant notification if the project is QA/QI or not. If a project is determined to be QA/QI, the project lead will receive an email that describes this determination, and that IRB review is not required. If your project does not meet criteria for QA/QI, the tool will guide you to the appropriate next steps. Be sure to familiarize yourself with the “University at Buffalo Guidance on Quality Assurance and Quality Improvement Projects” included in the assessment tool to learn more about what constitutes QA/QI, in order to prevent non-compliance if a project is later determined to constitute Human Research.

Recruitment Resources

The CTSI Community Engagement Core and Recruitment and Special Populations Core are available to help investigators achieve their recruitment goals, while the CTSI Recruitment Resources Toolkit offers links to study listings, participant databases, consultations, study resources, plain language, and advertising.