Our overall vision is to develop, demonstrate, and disseminate innovative programs to achieve translational success for the benefit of human health. The Biostatistics, Epidemiology, and Research Design (BERD) group of the Rockefeller Center for Clinical and Translational Science (CCTS) supports this vision by providing biostatistical and epidemiologic support to investigators and developing tools for dissemination to the entire CTSA consortium and scientific community. The Regulatory Knowledge and Support (RKS) Program supports the CCTS by ensuring that all studies are conducted to the highest standards. BERD specific aims: 1. To provide biostatistical service elements, including; participating in Translational Research Navigation, providing individual consultations on use of statistical approaches and use of statistical software platforms, reviewing research designs and statistical approaches for individual research protocols for the Advisory Committee on Clinical and Translational Science, and providing epidemiology consultations. 2. To provide continuing education courses in specific statistical domains. 3. To provide instruction for use of novel statistical methods and tools developed through research of CCTS Biostatisticians and to disseminate these tools to the CTSA-wide scientific community. RKS specific aims: 1. To ensure that CCTS conducts the highest quality research with the highest ethical principles, in compliance with all regulations through education, training, oversight, and infrastructure support. 2. To ensure the competence of the research community members in Good Clinical Practices. 3. To provide training in research participant advocacy and ensure ongoing research participant advocacy throughout the span and spectrum of research activities. 4. To provide coordination and collaboration with other CTSA hubs by disseminating tools developed by the CCTS to other hubs and by adopting best practices and utilizing tools developed by other CTSA hubs. BERD aims will be accomplished by having experienced biostatisticians advise on protocol design and statistical methods and lead CCTS-wide educational programs; BERD will also develop novel biostatistical methods related to the use of U-statistics and improving the predictive value of longitudinal data, and participate with other CTSA hubs in a novel educational program for junior investigators. Epidemiology will be taught through tutorials using participants’ research as case studies and one-on-one consultations. RKS aims will be accomplished by expert consultations and educational programs emphasizing GCP and the use of the iRIS and REDCap electronic platforms for protocol development and conduct. The Research Participant Perception Survey developed by the CCTS will be used as a key outcome measure. BERD and RKS will participate in CTSA-wide initiatives, disseminate novel tools, and adopt best practices.