Admin Core

管理核心

• 批准号: 10242128
• 负责人: Marc E. Rothenberg
• 金额: $ 43.26万
• 依托单位: CINCINNATI CHILDRENS HOSP MED CTR
• 依托单位国家: 美国
• 财政年份: 2014
• 资助国家: 美国
• 起止时间: 2014-08-15 至 2024-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10242128
• 关键词: Address; Adverse event; Advisory Committees; Advocacy; American; Biometry; Budgets; Clinical; Clinical Research; Clinical Trials; Communication; Data; Decision Making; Development; Disease; Elements; Enrollment; Ensure; Eosinophilic Colitis; Eosinophilic Esophagitis; Eosinophilic Gastritis; Ethics; Event; Family; Focus Groups; Fostering; Funding; Gastrointestinal Diseases; Goals; Guidelines; Individual; Industry; Informatics; Institution; International; Monitor; Online Systems; Pathology; Patients; Policies; Positioning Attribute; Principal Investigator; Procedures; Process; Professional Organizations; Protocols documentation; Publications; Rare Diseases; Reporting; Research; Research Personnel; Research Project Grants; Role; Site; Translational Research; United States National Institutes of Health; career; career development; clinical trial readiness; data management; eosinophilic gastroenteritis; insight; interest; meetings; news; operation; patient advocacy group; recruit; research study; success; web site

Project Summary (Administrative Core) This renewal application aims to continue research on rare eosinophilic gastrointestinal diseases (EGIDs) with a focus on eosinophilic esophagitis (EoE), eosinophilic gastritis (EG), eosinophilic gastroenteritis (EGE), and eosinophilic colitis (EC) through the Consortium of Eosinophilic Gastrointestinal Disease Researchers (CEGIR). CEGIR aims to promote highly collaborative, multi-site, patient-centric, translational and clinical research with the intent of addressing unmet clinical trial readiness needs. Though still in a relatively early stage, CEGIR is demonstrating success via its collaborative interactions between investigators (at all stages of career development), proactive patient advocacy groups (PAGs), and partnering institutions at the NIH and has emerged into the leading clinical and research group focused on rare EGIDs. The CEGIR Administrative Core aims to effectively generate and administer the policies, procedures, communications, and funds associated with CEGIR and ensure that the highest level of rigor, at all levels including scientific, is achieved. The CEGIR Administrative Core will be integral in coordinating decision-making and implementation to achieve the objectives of CEGIR. The CEGIR Administrative Core will include the CEGIR Director (Principal Investigator), Clinical Trial Liaison, and the CEGIR Internal Steering Committee. The CEGIR Internal Steering Committee will be composed of the Site Leaders, PAG representatives [i.e., American Partnership for Eosinophilic Disorders (APFED), Campaign Urging Research for Eosinophilic Diseases (CURED), Eosinophilic Family Coalition (EFC)], and Administrative Coordinators. Specific activities of the CEGIR Administrative Core include but are not limited to the following: 1) generate and administer research policies; 2) administer and monitor budgets and fund distribution; 3) provide oversight and guidance for CEGIR Cores and Committees; 4) review and distribute reports and proceedings from CEGIR Cores and Committees to appropriate audiences (e.g., stakeholders); 5) disseminate web-based information as per National Institutes of Health (NIH) guidelines and directives; 6) integrate valuable insight from the External Advisory Committee (EAC); and 7) foster integration and partnership with PAGs, other Rare Diseases Research Consortia, and stakeholders, including international liaisons. The Administrative Core will manage CEGIR operations ensuring that CEGIR achieves its goals in efficient, productive, and successful manners.

项目摘要（行政核心） 这项更新申请旨在继续研究罕见的嗜酸性粒细胞性胃肠道疾病（EGID）， 重点关注嗜酸性粒细胞性食管炎（EoE）、嗜酸性粒细胞性胃炎（EG）、嗜酸性粒细胞性胃肠炎（EGE）和 嗜酸性粒细胞性结肠炎（EC）通过嗜酸性粒细胞性胃肠疾病研究者联盟（CEGIR）。 CEGIR旨在促进高度协作，多站点，以患者为中心，转化和临床研究， 解决未满足的临床试验准备需求的目的。虽然仍处于相对早期的阶段，但CEGIR 通过调查人员之间的协作互动（在职业生涯的各个阶段）展示成功 发展），积极主动的患者倡导团体（PAG），以及NIH的合作机构， 成为专注于罕见EGID的领先临床和研究小组。CEGIR行政核心 旨在有效地制定和管理与以下方面相关的政策、程序、通信和资金： CEGIR并确保在包括科学在内的所有层面上达到最高水平的严格性。CEGIR 行政核心将在协调决策和执行以实现目标方面发挥不可或缺的作用 的CEGIR。CEGIR管理核心将包括CEGIR临床试验总监（主要研究者） 联络处和性别问题研究中心内部指导委员会。CEGIR内部指导委员会将由 现场负责人、PAG代表[即，美国嗜酸性粒细胞疾病伙伴关系（APFED）， 运动敦促研究嗜酸性粒细胞疾病（治愈），嗜酸性粒细胞家庭联盟（EFC）]，和 行政协调员。研究中心行政核心的具体活动包括但不限于 1）制定和管理研究政策; 2）管理和监督预算和资金 分发; 3）为CEGIR核心和委员会提供监督和指导; 4）审查和分发 CEGIR核心和委员会向适当受众提供的报告和会议记录（例如，利益攸关方）; 5） 根据美国国立卫生研究院（NIH）的指导方针和指令传播基于网络的信息; 6） 整合外部咨询委员会（EAC）的宝贵见解;以及7）促进整合和伙伴关系 与PAG、其他罕见疾病研究联盟和利益相关者，包括国际联络人。的 行政核心将管理CEGIR的运营，确保CEGIR以高效， 富有成效和成功的方式。