This Core, titled Service Core: Science and Training will have two distinct but integrated primary functions. The core will directly coordinate and support the research of Projects I and II (Clinical), while coordinating effort with Project III (preclinical) and serving the SCOR objectives. The Science Service component will provide essential common services to Projects I and II while maintaining close communication with Project III. These will include, though not be limited to: ). assuring availability of staff and resources for common procedures 2. IRB, FDA and other regulatory matters 3. subject recruitment 4. initial telephone screening 5. conducting consent, medical, psychiatric, and ongoing evaluation 6. monitoring nicotine and/or cocaine use using several techniques 7. adverse event and concomitant medication assessments 8. data safety and monitoring board/plan 9. coordinating data entry/preparation 10. ordering clinical study supplies/materials, and related functions 11. collaborating with other units with supporting resources These activities will be overseen by John Grabowski PhD and Alicia Allen MPH in consultation with the co-investigators and the P50 overall Mult Pi's, Marilyn Carroll PhD and Sharon Allen MD. Further, this service core will integrate bidirectional flow of information between the clinical projects (I and II) and the preclinical project (III). The Training Service component will establish linkages that facilitate mentoring at all levels. While formal mentoring is standard, this group is also focused on mentoring across all stages of career development. These activities will include though not be limited to: 1. Formal training of enrolled students of various disciplines 2. Informal training for immediate colleagues in associated departments and others in the institution 3. Providing training opportunities and promoting academic/professional advances for study staff 4. Scheduling and maintaining a monthly seminar series 5. Outreach to University of Minnesota schools, centers, and institutes, across its five campuses, to establish linkages for research and training 6. Outreach to other local colleges, universities and health care organizations All of the investigators have had extensive experience serving as mentors. The Core will sustain a roster of individuals benefitting from contact with the program and all training/educational initiatives. The strategies summarized are in keeping with Grabowski's previous medication development P50, and professional perspective, and will continue some features implemented in a P20 by Drs. Lim and Carroll (with collaborators Specker, Eberiy, Wozniak, Grabowski and others). This P50 is not a direct continuation of either the aforementioned P20 but will incorporate strengths of prior center programs. Most important is that this core provides the opportunity to capitalize on two activities essential to progress in the field;monitoring and facilitating rigorous science while providing resources and mentoring to others who can further advance the science. Additional Integral Service Core Functions This core will serve additional organizational functions, some linked to the Administrative Core and Analytic Core, others related to the Projects. It will collaborate in dissemination of research and training information. It will sustain the DSMB for Projects I and II. It will serve as a translation bridge among projects and coordinate with the Academic Health Centers Clinical and Translational Science Institute, which has broad academic, health care and community involvement. The P50 advisory committee will be available for consultation and all collaborating investigators will be consulted regarded significant decisions.
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