Severe Asthma Clinical Studies Core

项目总结/摘要 芯C 临床研究核心是PPG的组成部分，因为其旨在促进临床研究的开展。 通过规模经济和协调资源，在三个单独的项目中概述了试验。具体 临床研究核心的目标是：1）协助研究者访问、选择、招募， 保留哮喘受试者和健康志愿者，2）协助研究者计划、开发和执行 确保所有临床试验符合药物临床试验质量管理规范，3）管理IRB和法规 提交沿着批准后的文件和合规性，4）监督和/或执行测试 和程序，5）监督人体标本的采集和处理，6）促进 将基础科学研究者的发现转化为临床研究，7）协助研究者 通过将临床研究数据输入符合第11部分的数据库，8）维护数据库、组织和样本 从当前和既往患者/受试者中收集，9）向所有研究者提供数据库访问权限，以及10） 协助研究者进行数据分析和稿件准备。这个核心使我们能够很好地- 在印第安纳波利斯和克利夫兰进行临床研究， 从基础科学实验室的想法到床边翻译。核心支持的临床项目还 产生假设，这些假设又被送回基础科学实验室进行更详细的研究。的 临床研究核心是由经验丰富的个人谁是在各自领域的专家。

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.