Administrative Core Atopic Dermatitis Research Network

行政核心特应性皮炎研究网络

• 批准号: 8887203
• 负责人: DONALD YM LEUNG
• 金额: $ 195.47万
• 依托单位: NATIONAL JEWISH HEALTH
• 依托单位国家: 美国
• 资助国家: 美国
• 起止时间: 至
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/8887203
• 关键词: Area; Atopic Dermatitis; Bacterial Infections; Clinical; Clinical Practice Guideline; Collaborations; Communities; Contracts; DNA Repository; Data Coordinating Center; Development; Ensure; Evaluation; Event; Funding; General Population; Goals; Good Clinical Practice; Health; Host Defense Mechanism; Industry; Institution; Institutional Review Boards; International; Knowledge; Leadership; Maintenance; Microbe; Multi-Institutional Clinical Trial; National Institute of Allergy and Infectious Disease; Performance; Procedures; Registries; Research; Research Infrastructure; Research Personnel; Serum; Skin; Staphylococcus aureus; Study Subject; Time; Tissues; Training; United States National Institutes of Health; Vaccinia; Vaccinium; Virus Diseases; Work; base; data integrity; follower of religion Jewish; interest; novel; programs; repository; rho; safety study; skin disorder; symposium

Atopic dermatitis (AD) is the most common skin disease in the general population. It is associated with bacterial and viral infections thus providing a unique opportunity to study skin host defense mechanisms against microbes in a tissue accessible compartment of the body. The major objective of this administrative core is to oversee the operational, financial and managerial requirements of the Atopic Dermatitis Research Network (ADRN) to initiate and conduct studies expeditiously, maintain working committees, assure the safety of study subjects and integrity of data collected, and to disseminate new knowledge to the scientific community. These objectives will be maintained through accomplishment of the following Specific Aims. Specific Aim 1: Specific Aim 2: Specific Aim 3: Specific Aim 4: Specific Aim 5: Specific Aim 6: Specific Aim 7: Specific Aim 8: Specific Aim 9: To establish the Administrative Core that will plan and direct the ADRN's technical, operational, administrative and fiscal requirements. To establish and maintain the functions of committees responsible for governance and management of the ADRN. To establish efficient and accelerated IRB review, and approval of multi-site clinical trials. To establish plans and procedures to reduce redundancy, startup time, delays and excess due to duplicated infrastructure in ADRN. To formulate plans, in conjunction with the SACCC for training or verification of training of ADRN investigators and staff in accordance with Federal regulatory requirements, Good Clinical Practice guidelines and International Conference on Harmonization standards. To modify the research agenda based on new scientific developments. To establish and implement collaborations with other Federal and non-Federal organizations/institutions for the co-sponsorship of research in areas of mutual interest and collaborations with industry for the evaluation of specific products/approaches. To provide a plan for leadership succession in the event the PD/PI is unable to continue. To maintain, manage and expand the ADRN Registry, ADRN Serum Repository, DNA Repository and Staphylococcus Aureus Repository. Accomplishment of these specific aims will ensure the efficient implementation and performance of proposed clinical interventional and mechanistic studies in this ADRN application as well as optimal maintenance, management and expansion of the ADRN Registry and repositories contributing to novel and important advances in our understanding of mechanisms of host skin defense, and paradigm shifting treatments of AD.

特应性皮炎（AD）是普通人群中最常见的皮肤病。它与 细菌和病毒感染，因此提供了一个独特的机会来研究皮肤宿主防御机制 针对人体可及的隔室中的微生物。这项行政的主要目标 核心是监督特应性皮炎研究的运营，财务和管理要求 网络（ADRN）迅速启动和进行研究，维护工作委员会，确保安全 研究主题和收集数据的完整性，并将新知识传播到科学上 社区。这些目标将通过实现以下特定目标来维持。 具体目标1： 具体目标2： 具体目标3： 具体目标4： 具体目标5： 具体目标6： 具体目标7： 具体目标8： 具体目标9： 建立将计划和指导ADRN技术的行政核心， 运营，行政和财政要求。 建立和维护负责治理的委员会的职能 ADRN的管理。 建立有效且加速的IRB审查，并批准多站点临床试验。 建立计划和程序以减少冗余，启动时间，延迟和过剩 由于ADRN的重复基础设施。 为了制定计划，与SACCC一起培训或验证培训 根据联邦监管要求，ADRN的调查人员和工作人员，良好 临床实践指南和国际协调标准会议。 根据新的科学发展修改研究议程。 与其他联邦和非联邦建立和实施合作 组织/机构在共同利益领域的研究共同赞助和 与行业的合作评估特定产品/方法。 如果PD/PI无法继续下去，则提供领导力继承计划。 维护，管理和扩展ADRN注册表，ADRN血清存储库，DNA 存储库和金黄色葡萄球菌存储库。 完成这些特定目标将确保提议的有效实施和绩效 在此ADRN应用中以及最佳维护中的临床介入和机械研究， ADRN注册表的管理和扩展，以及为新颖而重要的 我们对宿主皮肤防御机制的理解以及AD的范式转移治疗的进步。