Clinical Imaging and Data Resources Core

摘要-临床成像和数据资源核心 该临床成像和数据资源核心（CIDRC）的总体目标是提供研究 该COBRE的项目负责人（RPL），在监管和科学支持下， 医学影像相关的转化癌症研究项目。CIDRC将作为一个重要的桥梁， 在俄克拉荷马州大学加洛格利工程学院进行的生物医学成像研究 (OU)诺曼校园和临床研究社区的斯蒂芬森癌症中心（SCC）的 健康科学中心（OUHSC）校园。建立一个强有力、安全和持久的机制， 用于存储和共享图像、临床样本和相关数据的平台对于开发和 这是COBRE计划的成功之处。CIDRC的组织将确保提供科学有效的 和良好表征的图像数据，并符合所有NIH监管要求， 人类受试者和动物模型研究，并鼓励 生物医学影像工程和临床研究。CIDRC将在OUHSC的SCC中建立 因为OUHSC提供广泛的临床研究服务，包括机构审查委员会 (IRB)审查和批准转化临床研究项目，生物统计学核心和服务， 检索存档的医学图像和H&E染色的组织病理学切片，以及癌症的其他临床数据 诊断结果和治疗结果。该CIDRC将整合和加强现有的临床研究 支持位于OUHSC校园的资源，以建立一个新的和独特的研究资源平台， 培训和支持该COBRE的RPL和试点获奖者开展联合转化癌症研究 两个校园的项目。CIDRC的整体运作将包括：（1）确保可回收许可证充分 了解所有NIH关于保护人类受试者和脊椎动物福利的政策和法规， (2)证明回顾性和前瞻性研究的研究方案完全符合所有NIH- 强制性法规要求，（3）协助IRB方案申请的撰写和提交，（4） 提供生物统计学支持，以确认实验设计具有适当的样本量或统计 功率和适当的统计数据分析方法用于测试和验证基础 具有高度科学严谨性的假设，以及（5）建立一个独特的平台，可以提供RPL和其他 共享数据库的研究人员可以访问链接的注释医学图像、生物标本 和临床数据，以促进他们提出的研究项目。因此，CIDRC将建立一个关键的 科学和智力支持基础设施，旨在确保COBRE作为RPL的成功 在他们的研究项目取得进展，并过渡到独立的研究人员进行医疗 影像学相关的转化性癌症研究，具有高度的临床影响力和科学严谨性。

ABSTRACT – Clinical Imaging and Data Resources Core The overarching objective of this Clinical Imaging and Data Resources Core (CIDRC) is to provide research project leaders (RPLs) of this COBRE with both regulatory and scientific support to facilitate their effort to conduct medical imaging related translational cancer research projects. The CIDRC will serve as a crucial bridge between the biomedical imaging research performed in the Gallogly College of Engineering on the University of Oklahoma (OU) Norman campus and the clinical research community in the Stephenson Cancer Center (SCC) on the OU Health Science Center (OUHSC) campus. Establishment of a robust, secure and durable mechanism and platform for storing and sharing images, clinical samples, and associated data is critical to the development and success of this proposed COBRE. The CIDRC will be organized to ensure the availability of scientifically valid and well-characterized image data, and the compliance with all NIH regulatory requirements in conducting human subject and animal model studies, as well as to encourage broad collaborative research efforts between the biomedical imaging engineering and clinical research. The CIDRC will be established in the SCC of OUHSC campus because OUHSC provides the broad clinical research service including the Institutional Review Board (IRB) to examine and approve translational clinical research projects, the biostatistics Core, and services to retrieve the archived medical images and the H&E stained histopathology slides, and other clinical data of cancer diagnosis results and treatment outcome. This CIDRC will integrate and strengthen the existing clinical research supporting resources located on the OUHSC campus to build a new and unique research resource platform to train and support the RPLs and pilot awardees of this COBRE to conduct joint translational cancer research projects on two OU campuses. The overall operation of the CIDRC will include to: (1) ensure that RPLs fully understand all NIH policies and regulations for protection of human subjects and welfare of vertebrate animals, (2) certify that study protocols for both retrospective and prospective studies are fully compliant with all NIH- mandated regulatory requirements, (3) assist with the IRB protocol application writing and submission, (4) provide biostatistics support to confirm that experiments are designed with appropriate sample sizes or statistical power and the proper statistical data analysis methodologies are used to test and validate the underlying hypothesis with high scientific rigor, and (5) establish a unique platform that can provide RPLs and other researchers with the shared databases allowing access to the linked annotated medical images, biospecimens and clinical data necessary to facilitate their proposed research projects. Thus, the CIDRC will build a critical scientific and intellectual support infrastructure that aims to ensure the success of this COBRE as the RPLs make progress in their research projects and transition to the independent researchers in conducting medical imaging related translational cancer research with the high clinical impact and scientific rigor.