Biostatistics & Data Validation Core

生物统计学和数据验证科学核心：摘要 生物统计和数据验证（BDV）科学核心的总体目标是确保科学严谨性， 结果的可靠性，以及在拟议的计划内进行的研究的再现性，题为“多- 内部放射性核素污染后毒性的规模评价和减轻。而 该计划的跨学科性质和协同作用是独特的优势，它也可以提出挑战， 不同机构的研究项目之间的整合，特别是在标准化数据方面 管理和统计方法。因此，BDV核心将为统计提供综合支持， 设计和分析、源项特性、数据管理以及模型和结果的验证。 来自合作机构的主要研究者（PI）将随时访问生物统计学家团队， 辐射主题专家和医疗从业人员，负责协调、验证和执行 研究实验、数据管理和分析。BDV核心将与研究部门密切合作， 项目PI，以确保合理的实验设计，统计方法和放射源术语 使用和记录，这是确保结果可靠和可重现的关键因素。一个独特 该核心的一个方面是实施战略验证和基准制定流程，通过以下方式完成 从文献、模型和其他可用来源中确定适当的数据集或结果，以用于 敏感性分析和比较，以确认该计划的推论和结果与 已知或以前报告的结果。这一努力，加上放射治疗提供的临床前景， 医学专家，是至关重要的，以确保研究成果和产品的完整性，同时促进转化为 现场辐射防护、辐射照射和损伤的医疗管理及 医学对策此外，BDV核心对程序数据储存库的集中管理， 在计划管理核心的监督下，将确保数据的完整性、可访问性和版本控制。 总之，生物统计学、辐射源术语表征、验证分析、 BDV核心提供的数据管理将为成功的 完成计划中提出的研究项目。

Biostatistics and Data Validation Scientific Core: Abstract The overall goal of the Biostatistics and Data Validation (BDV) Scientific Core is to ensure scientific rigor, reliability of results, and reproducibility of research undertaken within the proposed Program, entitled, ‘Multi- Scale Evaluation and Mitigation of Toxicities Following Internal Radionuclide Contamination’. While the interdisciplinary nature and synergies of this Program are unique strengths, it can also present challenges for integration between research projects at different institutions, particularly with regard to standardized data management and statistical approaches. As such, the BDV Core will provide integrated support for statistical design and analyses, source term characterization, data management, and validation of models and findings. Principal Investigators (PIs) from collaborating institutions will have ready access to the team of biostatisticians, radiation subject matter experts, and medical practitioners for the coordination, verification, and execution of research experiments, data management, and analyses. The BDV Core will collaborate closely with research project PIs to ensure that sound experimental designs, statistical methodologies, and radiological source terms are utilized and documented, a critical factor in assuring that results are reliable and reproducible. A unique aspect of this Core is the implementation of strategic validation and bench-marking processes, accomplished by identifying appropriate datasets or results from literature, models, and other available sources for use in sensitivity analyses and comparisons to confirm that inferences and results from the Program are consistent with known or previously reported findings. This effort, coupled with clinical perspective provided by radiation medicine experts, is critical to ensuring integrity of research results and products while promoting translation into practice for in-field radiation protection, medical management of radiation exposure and injury, and use of medical countermeasures. Further, centralized management of the Program data repository by the BDV Core, with oversight from the Program Administrative Core, will ensure data integrity, accessibility, and version control. In conclusion, the integrated expertise in biostatistics, radiation source term characterization, validation analyses, and data management provided by the BDV Core will provide valuable scientific support for the successful completion of the proposed research projects in the Program.