INTERIM SUPPORT FOR THE DS CONNECT ONLINE REGISTRY

对 DS CONNECT 在线注册表的临时支持

• 批准号: 10915373
• 负责人: JILL ANDRES
• 金额: $ 69.36万
• 依托单位国家: 美国
• 财政年份: 2020
• 资助国家: 美国
• 起止时间: 2020-09-30 至 2024-02-27
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10915373
• 关键词: Age; Award; Biological Specimen Banks; Childhood; Clinical Research; Clinical Trials; Cloud Service; Common Data Element; Communication; Communities; Contract Services; Contractor; Contracts; Data; Data Coordinating Center; Data Security; Data Set; Data Sources; Demographic Survey; Development; Documentation; Down Syndrome; Elements; Family; Fostering; Funding; Future; Government; Growth; Health; Health Personnel; Health Status; Health Surveys; Individual; Internet; Investigation; Language; Libraries; Longevity; Maintenance; Marketing; Medical; Names; National Institute of Child Health and Human Development; Online Systems; Parents; Participant; Personally Identifiable Information; Persons; Pharmaceutical Preparations; Policies; Pregnancy; Pregnant Women; Questionnaires; Recording of previous events; Registries; Regulation; Research; Research Personnel; Research Support; Resources; Review Committee; Schedule; Security; Services; Specimen; Staff Development; Surveys; Symptoms; System; Trust; United States National Institutes of Health; Work; crowdsourcing; data access; data de-identification; data exchange; data hub; data registry; data submission; design; experience; information gathering; interest; medical specialties; member; migration; mobile application; online registry; operation; outreach; patient registry; recruit; response; sex; success; web services; web site

The Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) at the National Institutes of Health (NIH) is soliciting support services to maintain and continue a System of Record (SOR) to support one online study registry, DS-Connect® that contains personally identifiable information (PII) and includes a responsive-template website and professional portal, all of which are Section 508 compliant in accordance with HHS regulations (https://www.hhs.gov/web/section-508/). The SOR will reside in the cloud and adhere to a Federal Information Security Management Act (FISMA)-moderate level of security controls. These support services will also include working with NIH/NICHD staff to transition this registry data to a successor contractor within this 6-month period of extension and export of deidentified data to the INCLUDE Data Coordinating Center Data Hub twice per year. Research Data Patient Registry (RDPR) The NICHD awarded a contract in September 2012 to create and maintain an online registry named DS- Connect®: The Down Syndrome Registry, which was subsequently housed in a SOR known as the Research Data Patient Registry (RDPR) and contained PII. This contract was recompeted in 2015 (adding in the creation and maintenance of the PregSource® registry) and again in 2018. The RDPR is currently hosted on the Amazon Web Services (AWS) cloud, and houses two online registries: • DS-Connect®: The Down Syndrome Registry (https://dsconnect.nih.gov/), and • PregSource®: Crowdsourcing to Understand Pregnancy (https://pregsource.nih.gov/). This registry is being discontinued with its data migrated to the NICHD DASH resource by August 2023. Each participant in DS-Connect is given a Global Unique Identifier (GUID) generated based on PII elements. This allows information to be combined between data sources or biospecimen repositories by matching to the GUID without revealing PII. This contract is to provide interim support for the DS Connect Online Registry during the Six-Month Extension of services for contract Number: 75N94020F00276 to provide continuity of operations and support transition from August 28, 2023, through February 27, 2024.

美国国立卫生研究院（NIH）的Eunice Kennedy Shriver国家儿童健康和人类发展研究所（NICHD）正在寻求支持服务，以维护和继续使用记录系统（SOR），以支持一个在线研究注册中心DS-Connect®，该注册中心包含个人身份信息（PII），并包括一个响应模板网站和专业门户网站，所有这些都符合HHS法规（https：//www.hhs.gov/web/section-508/）的第508条。SOR将驻留在云中，并遵守联邦信息安全管理法案（FISMA）-中等级别的安全控制。这些支持服务还将包括与NIH/NICHD工作人员合作，在6个月的延长期内将该登记数据转移至后续承包商，并每年两次将去识别数据导出至INCLUDE数据协调中心数据中心。 研究数据患者登记（RDPR） NICHD于2012年9月授予了一份合同，以创建和维护名为DS-Connect ®的在线登记：唐氏综合征登记，该登记随后被安置在称为研究数据患者登记（RDPR）的SOR中，并包含PII。该合同于2015年重新完成（增加了PregSource®注册表的创建和维护），并于2018年再次完成。 RDPR目前托管在Amazon Web Services（AWS）云上，并包含两个在线注册中心： · DS-Connect®：唐氏综合征登记处（https：//dsconnect.nih.gov/），以及 · PregSource®：众包了解怀孕（https：//pregsource.nih.gov/）。该登记研究将于2023年8月停止，其数据将迁移到NICHD DASH资源。 DS-Connect中的每个参与者都将获得一个基于PII元素生成的全球唯一标识符（Global Unique Identifier，简称PII）。这允许通过匹配数据库在数据源或生物样本存储库之间组合信息，而不会泄露PII。 本合同将在合同编号为75 N94020 F00276的六个月服务延期期间为DS Connect在线注册中心提供临时支持，以提供运营的连续性并支持从2023年8月28日到2024年2月27日的过渡。