Severe Asthma Clinical Studies Core

严重哮喘临床研究核心

• 批准号: 10269969
• 负责人: JAMES F CHMIEL
• 金额: $ 30.26万
• 依托单位: INDIANA UNIV-PURDUE UNIV AT INDIANAPOLIS
• 依托单位国家: 美国
• 财政年份: 2021
• 资助国家: 美国
• 起止时间: 2021-08-01 至 2026-04-30
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10269969
• 关键词: Address; Adverse event; Agreement; Archives; Area; Asthma; Basic Science; Biological; Biological Process; Biopsy; Biostatistics Core; Budgets; Clinical; Clinical Data; Clinical Research; Clinical Trials; Clinical Trials Data Monitoring Committees; Collection; Communication; Conduct Clinical Trials; Consultations; Contracts; Data; Data Analyses; Data Collection; Data Storage and Retrieval; Databases; Development; Documentation; Ensure; Exhalation; Good Clinical Practice; Human; Human Resources; Indiana; Individual; Institution; Institutional Review Boards; Investigation; Laboratories; Manuscripts; Measurement; Medical; Mentors; Monitor; Nitric Oxide; Nose; Participant; Patients; Phase; Population; Preparation; Procedures; Protocols documentation; Pulmonary function tests; Quality Control; Radiology Specialty; Records; Reporting; Research; Research Design; Research Personnel; Research Project Grants; Resources; Safety; Schedule; Services; Site; Source; Specimen; Study Subject; Testing; Therapeutic; Tissue Sample; Training; Translations; Universities; Visit; Work; bench to bedside; career; clinical investigation; cost effective; data repository; design; experience; healthy volunteer; improved; innovation; interest; material transfer agreement; next generation; operation; participant safety; performance tests; programs; recruit; sample collection; success; synergism

PROJECT SUMMARY/ABSTRACT Core C The Clinical Studies Core is an integral component of the PPG as it is designed to facilitate the conduct of clinical trials outlined in the three individual projects through economy of scale and coordinated resources. Specific objectives of the Clinical Studies Core are to 1) Assist investigators in accessing, selecting, recruiting, and retaining asthma subjects and healthy volunteers, 2) Assist investigators in planning, developing, and execution of clinical projects and ensuring that all clinical trials meet good clinical practices, 3) Manage IRB and regulatory submissions along with post-approval filings and compliance, 4) Provide oversight and/or performance of tests and procedures, 5) Provide oversight to the collection and processing of human specimens, 6) Facilitate the translation of discoveries made by basic science investigators into clinical investigation, 7) Assist investigators by entering clinical study data into a Part 11 compliant database, 8) Maintain a bank of data, tissues and samples collected from current and former patients/subjects, 9) Provide access to databases to all investigators, and 10) Assist investigators in data analyses and manuscript preparation. This Core makes available our well- characterized asthma populations in both Indianapolis and Cleveland for clinical studies and facilitates the bench to bedside translation of ideas from our basic science laboratories. The Core-supported clinical projects also generate hypotheses that are in turn returned to basic science laboratories for more detailed investigation. The Clinical Studies Core is staffed with experienced individuals who are experts in their respective fields.

项目摘要/摘要 核心C 临床研究核心是PPG的一个组成部分，因为它旨在促进临床研究的进行 通过规模经济和协调资源，在三个单独项目中概述了试验情况。特定的 临床研究核心的目标是1)协助研究人员访问、选择、招募和 留住哮喘受试者和健康志愿者，2)协助调查人员计划、开发和执行 临床项目并确保所有临床试验符合良好的临床实践，3)管理IRB和监管 提交文件以及批准后提交的文件和合规性，4)提供测试的监督和/或执行 和程序，5)监督人类标本的收集和处理，6)促进 将基础科学研究人员的发现转化为临床研究，7)协助调查人员 通过将临床研究数据输入符合第11部分标准的数据库，8)维护数据库、组织和样本 从现任和前任患者/受试者收集，9)向所有调查人员提供访问数据库的权限，以及10) 协助调查人员进行数据分析和手稿准备。这个核心使我们的油井- 印第安纳波利斯和克利夫兰哮喘人群的特征，用于临床研究，并为法官提供便利 到床边翻译我们基础科学实验室的想法。核心支持的临床项目也 产生假说，这些假说又被送回基础科学实验室进行更详细的研究。这个 临床研究核心的工作人员是经验丰富的个人，他们是各自领域的专家。