Resources

• The BERD delivers expert collaboration in clinical study development, providing study design support to investigators including assistance in formulating objectives and hypotheses, establishing the specified study population, selecting treatment groups, and determining sample size. In addition, BERD members provide statistical analysis plans based on modern methods which meet the standards of the most rigorous review processes.
• The Community Engagement Core and Clinical Recruitment Coordinator will consult with research teams on integrating community into the design and implementation of research studies and recruiting participants who are broadly representative of our community. This includes feedback from community members on aspects of your study through community engagement studios, development of community advisory boards, and identification of community partners. Assistance with community-based recruitment strategies includes the Buffalo Research Registry, a local registry of people interested in participating in research. The online Recruitment Resources Toolkit provides methods to enhance recruitment for research studies.
• Via the Informatics Core, investigators can model their studies using retrospective data in order to to ensure that participants are broadly representative of our community.

• The Trial Innovation Network (TIN) is a national collaborative initiative within the NIH Center for Advancing Translational Services (NCATS) CTSA Program addressing roadblocks for NIH clinical trials and accelerating translational research. There are opportunities for investigators to join multi-site trials or for investigators to recruit other sites to participate in their multi-site trials. Investigators can request consultations and other services for multi-center clinical trials and studies. The TIN offers investigators the ability to request an initial consultation or specific services depending on the funding status of the proposal. To learn more about TIN, contact UB's TIN liaison team at ctsiresearch@buffalo.edu.

• The Workforce Development Core supports investigators, students, scholars and research support staff through the development and maintenance of key educational activities on clinical and translational science topics. This support includes the Distinguished Speaker Seminars, Core Competency Workshop series, Professional Development Workshop series, and translational teamwork. 

• Central Study Registration (CSR) is the central place to begin processes required to begin the implementation of research trials involving human subjects. Contact the Clinical Research Office (CRO) with any questions about which studies need to be processed through CSR.

• Clinical Research Office (CRO) advances contract negotiations to establish the legal parameters of the working relationship for the study. 
• Sponsored Projects Services (SPS) works in conjunction with other UB business offices regarding award set up, management, and close out.
• Industry sponsored studies are contracted through the CRO, while federal awards are administered by SPS. Contact Research Facilitation for more information about contracting.

• Clinical Research Office (CRO) works with investigators in budget development and negotiation for clinical research studies. 

Assistance is provided to investigators and research teams in the following areas:

• Regulatory Assistance 
• ClinicalTrials.gov
• Investigational New Drug (IND)
• Investigational Device Exemption (IDE)
• Humanitarian Use Device (HUD)

• Institutional Review Board (IRB)
  
• Regulatory Assistance
  
• Research Facilitation

• CTSI Recruitment Resources Toolkit

• Pharmacy, exam rooms, sample processing, etc. (Clinical Research Center)

• The RIC is an organizational partner within the Trial Innovation Network (TIN).

• The BERD provides data monitoring support to clinical studies including, when appropriate, assistance in the design of the data monitoring plan, construction of appropriate data reports based on collected variables so to assess the on-going risk-benefit ratio of study participants, assessment of trial accrual rates, and implementation of planned interim statistical analyses for use in making informed mid-study decisions.

• BERD members carefully select randomization algorithms for clinical trials ensuring comparability of treatment groups. Furthermore, BERD members contribute to the development of mechanisms to implement such procedures during the study which range from the simplistic to more complex web-based systems often used for multi-site trials.

• The BERD provides database design and statistical programming support in order to facilitate the timely production of reports and analysis results.

• BERD-produced statistical analyses plans, whether defined according to a pre-specified analytic plan or those which are exploratory in nature, are implemented and used to generate comprehensive statistical reports for use in publications and/or presentations.

• IRB Closures (CLICK)
  
• Account Closures (CRO)

• ClinicalTrials.gov
• Regulatory Assistance
• BERD provides additional analyses at the request of external regulatory and oversight groups and assists in the construction of all study reports.

• Cite the Award

• The Community Engagement Core and Recruitment and Special Populations Core will consult with research teams on methods to disseminate research findings for use in real world settings to advance health, healthcare and health policy. 
  
• UB’s Division of University Communications promotes UB’s research and teaching to local and global media. Once a research grant is awarded and/or when research is published, faculty are advised to contact the designated University Media Contact for options to publicize their work.