Clinical 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 CTRC, a personal contact, an email or a phone call.

The facilitators triage the movement of studies through the various university research systems and can arrange consultations and services with any of the CTSI cores.

Our regulatory administrator provides clinical regulatory assistance, guidance and education to investigators and study coordinators.

The regulatory administrator will work 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.

For more information on registering studies in ClinicalTrials.gov including FAQs, a "ClinicalTrials.gov Registration Guide" Download docx is available for investigators and their research teams.

Participant recruitment can pose a challenge for clinical trial teams. We assist researchers across the Buffalo Translational Consortium in preparing and implementing successful recruitment strategies, with a special emphasis on recruiting underserved minorities and special populations. Our recruitment team can facilitate access to resources during any phase of a research study.

Our clinical research recruitment coordinator works with research coordinators and investigators to identify and facilitate appropriate recruitment strategies for clinical studies and to develop and implement novel recruitment strategies, including:

• Initial consultations
• Assistance with developing advertising materials (flyers, brochures, radio, newspaper, bus shelter ads)

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 access directly via the CTSI service request portal:

We can provide preliminary recommendations and referrals to in-depth consultations on:

We conduct pre-reviews of IRB submission to advise on:

• Proper use of templates
• Package submission requirements
•  Section-by-section guidance on completion of a protocol (503 or 508) and consent
• Navigating through Click IRB

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 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.

The single greatest obstacle to performing clinical research is recruiting people to participate in clinical trials. The CTSI recruitment coordinator will guide you through the many resources that are available to help investigators achieve their recruitment targets.