Human Subjects Research Electronic Tracking System

要求提供资金，以完成“综合注册信息系统”的开发和实施， 收集、维护和管理涉及人类研究志愿者的医学研究的研究数据。IRIS将与BRAAN接口，BRAAN是我们用于管理IRB文件和业务的基于网络的系统，这些文件和业务是用以前通过HSREP获得的资金购买的。 IRIS将管理研究受试者的招募和时间安排， 研究数据、临床实验室结果的自动采集、方案特定病例报告的生成和中期数据分析。IRIS将从BRAAN接收人口统计学和研究设计数据，并将汇总信息返回给BRAAN进行持续审查（受试者的人口统计学和状态）。如果需要进行IRB合规性审查，IRIS将能够向质量管理人员提供所有受试者的身份、状态和详细数据。 BRAAN将存储关于不良事件的部分去识别信息和总结报告。 BRAAN中的每份严重不良事件（SAE）报告将在IRIS中有一个链接记录，该记录将存储与SAE相关的详细医学信息（包含标识符）。虽然所有IRB成员都可以访问BRAAN中的信息，但IRIS中的详细报告仅限于负责对不良事件进行深入医学评价的IRB成员子集。 综合注册资讯系统将会发展，供其他机构使用。为了确保它将有广泛的 为确保适用性，我们会在开始时考虑一些可能需要特别设计的设施，以配合不同地盘的特别需要。为了获得必要的校外视角，我们将与西弗吉尼亚大学合作这个项目。虽然在上一轮HSREP中没有获得NIH的资助，但WVU有一个活跃且不断增长的人类受试者研究项目，并强烈考虑为其IRB购买BRAAN。西弗吉尼亚大学有一个不同的组织结构，一个不同的信息技术网络，和不同的人类学科的研究重点从马里兰州医学院的大学。

Funds are requested to complete development and implementation of IRIS, a web-based application designed to collect, maintain and manage research data for medical studies involving human research volunteers. IRIS will interface with BRAAN, our web-based system for managing IRB documentation and business that was purchased with funds previously obtained through HSREP. IRIS will manage recruitment and scheduling of research subjects, collection and archiving of research data, automated acquisition of clinical laboratory results and generation of protocol-specific case reports and interim data analysis. IRIS will receive demographic and study-design data from BRAAN and it will return aggregate information back to BRAAN for the continuing review (demographics and status of subjects). If lRB compliance review is required, IRIS will be able to provide quality management personnel with identity, status, and detailed data for all subjects. BRAAN will store partially de-identified information and summary reports about adverse events. Each Serious Adverse Event (SAE) report in BRAAN will have a linked record in IRIS that will store the detailed medical information, containing identifiers, relating to the SAE. While all IRB members will have access to the information in BRAAN, access to the detailed reports in IRIS will be restricted to the subset of IRB members who are entrusted with the responsibility of in-depth medical evaluation of adverse events. IRIS will be developed for use by other institutions. In order to assure that it will have wide applicability, we will plan, from the outset, to give consideration to design features that may require customization to meet specific needs of different sites. To gain the necessary extramural perspective, we will collaborate with West Virginia University on this project. Although it did not receive NIH funding during the previous round ofHSREP, WVU has an active and growing human subjects research program, and is strongly considering purchasing BRAAN for its IRB. WVU has a different organizational structure, a different information technology network, and different human subjects research emphasis from the University of Maryland School of Medicine.