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

美国卫生与公众服务部(HHS)下属的美国国家卫生研究院(NIH)的国家糖尿病与消化及肾脏疾病研究所(NIDDK)进行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。存储和允许随后使用在临床研究中收集的生物材料和相关数据是NIDDK履行其责任的一种方式，以最大限度地提高这些研究的价值。2003年，NIDDK建立了NIDDK中央储存库，由数据和标本储存库组成，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。这些资料库使没有参与原始研究的科学家能够测试新的假设，而不需要任何新的数据或生物样本收集，它们提供了在几项研究中汇集数据的机会，以增强统计分析的能力。NIDDK中央资料库下有两个资料库：NIDDK生物资料库接收在许多不同研究中收集的生物样本，在最佳条件下存储样本，并将其分发给合格的研究人员。NIDDK数据仓库接收、存档、维护和分发来自研究的数据库。此外，NIDDK数据存储库根据查询分析存储的数据，协助正在进行的由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参考，并维护NIDDK中央存储库网站(https://repository.niddk.nih.gov/home).NIDDK中央资料库收集的生物样本和相关的临床、诊断、基因型别、系谱结构和其他数据是推动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将被称为“NIDDK数据存储库”，它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，并充当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高效提交、分发以及过程监控和报告。作为高度可用的遗留数据集的档案和分发者，NIDDK数据储存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，从而鼓励调查人员和其他未包括在最初资助的研究中的人开展工作。有关NIDDK中央资料库的更多信息，请访问网站：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.