Task Area A-Maintaining and Enhancing the NIDDK Central Repository Program

美国国家卫生研究院（NIH）、美国卫生与公众服务部（HHS）的国家糖尿病、消化和肾脏疾病研究所（NIDDK）开展并资助各种临床研究，这些研究产生或已经产生了与这些研究活动有关的生物标本（生物标本）和相关表型和临床数据/资源的集合。存储和允许后续使用临床研究中收集的生物材料和相关数据是NIDDK履行其职责以最大限度地发挥这些研究价值的一种方式。2003年，NIDDK建立了NIDDK中央储存库，包括数据和标本储存库，以通过向更广泛的科学界提供数据和生物标本来增加NIDDK资助的大型临床研究的影响。这些数据库使没有参与原始研究的科学家能够在没有任何新数据或生物样本收集的情况下测试新的假设，并且它们提供了汇集多项研究数据的机会，以提高统计分析的能力。在NIDDK中央储存库的保护下有两个储存库：NIDDK生物储存库接收在许多不同研究中收集的生物样品，在最佳条件下储存样品，并将其分发给合格的研究人员。NIDDK数据存储库接收、存档、维护和分发研究数据库。此外，NIDDK数据存储库分析存储的数据以回应查询，协助正在进行的NIDDK资助的研究准备最终存档的数据，协调临床数据和生物样本之间的交叉引用，并维护NIDDK中央存储库网站（https：//repository.niddk.nih.gov/home）。NIDDK中央储存库收集的生物样本和相关的临床、诊断、基因型、谱系结构和其他数据是促进许多疾病诊断和治疗工具开发的资源。本工作说明书中描述的项目（在本文中称为“NIDDK数据存储库”）存储来自这些研究的临床研究数据，包括与存储的生物样本相关的数据，并作为NIDDK中央存储库的中央协调实体。NIDDK数据存储库促进了与研究数据和样本相关的有效提交、分发和过程监测和报告。作为高度可用的遗留数据集的存档和分发者，NIDDK数据存储库还允许重新分析这些数据，并在相关情况下重新分析特定的生物样本，从而鼓励研究人员和其他未包括在原始资助研究中的人开展工作。有关NIDDK中央存储库的更多信息，请参阅网站https://repository.niddk.nih.gov/home。

The National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) at the National Institutes of Health (NIH), U.S. Department of Health and Human Services (HHS), conducts and funds various clinical studies that generate or have generated a collection of biological specimens (biospecimens) and related phenotypic and clinical data/resources pertaining to these research activities. Storing and allowing subsequent use of biological materials and associated data collected in clinical studies is one way for the NIDDK to meet its responsibility to maximize the value of these studies. In 2003, the NIDDK established the NIDDK Central Repository, comprised of the data and specimen repositories to increase the impact of NIDDK-funded large clinical studies by making their data and biospecimens available to the broader scientific community. These repositories enable scientists not involved in the original study to test new hypotheses without any new data or biospecimen collection, and they provide the opportunity to pool data across several studies to increase the power of statistical analyses. There are two repositories under the umbrella of the NIDDK Central Repository: the NIDDK Biorepository receives biosamples collected in many different studies, stores the samples under optimal conditions, and distributes them to qualified investigators. The NIDDK Data Repository receives, archives, maintains, and distributes databases from studies. In addition, the NIDDK Data Repository analyzes stored data in response to inquiries, assists ongoing NIDDK-funded studies in preparing data for eventual archiving, coordinates cross-referencing between the clinical data and biosamples, and maintains the NIDDK Central Repository website (https://repository.niddk.nih.gov/home). The NIDDK Central Repository’s collection of the biosamples and associated clinical, diagnostic, genotypic, pedigree structure and other data is a resource that advances the development of diagnostic and treatment tools for many diseases. The project described in this Statement of Work, which will be referred to herein as the “NIDDK Data Repository,” stores the clinical research data from these studies, including data associated with the stored biosamples, and acts as the central coordinating entity for the NIDDK Central Repository. The NIDDK Data Repository facilitates efficient submission, distribution, and process monitoring and reporting related to study data and samples. As an archive and distributor of highly usable legacy datasets the NIDDK Data Repository also allows re-analysis of these data and, where relevant, of specific biosamples, thus encouraging work by investigators and others not included in the original funded studies. For more information on the NIDDK Central Repository, refer to the website at https://repository.niddk.nih.gov/home.