Creation of a Secured IRB Protocol Management System

杜克大学Heatlh系统每年管理超过2400个IRB方案。杜克的MPA包括在其系统中的三家医院和整个地区的诊所的调查人员的责任。目前，五个IRB审查和监测这些方案。此外，调查人员经常在办公室以外的地方工作，需要访问IRB系统及其协议。由于正在进行IRB审查的临床试验数量持续快速增长，因此杜克的IRB报告管理系统必须得到改进和扩展。我们还预计与实施HIPAA相关的IRB工作会增加。为了应对对IRB的这些需求，我们必须创建新的设施和系统来满足我们的需求。杜克大学卫生系统提出通过三种方法来满足这些需求。 首先，该机构将把IRB的数量从5个增加到6个。IRB数量的增加以及当前IRB的大量活动水平要求我们创建新的设施来适应这种活动水平。这也将要求为IRB协议的保密处理和存储开发安全空间。我们建议利用这一支持，在新的IRB办公室为记录和计算机服务器创建一个安全的存储单元。 其次，我们打算开发一个安全的、基于网络的电子IRB提交和跟踪系统。该系统将允许管理新方案和正在接受持续审查的方案，记录不良事件、修正案和稽查报告，记录教育培训和认证，以及制定I/II期数据和安全性监测计划。elRB系统还将允许利益冲突委员会、赠款办公室和IRB之间更有效的沟通。我们正在申请资金，以建立和实施这样一个系统。 最后，我们建议为系统的用户开发一个培训计划，其中包括一个模块，重点是使用电子数据库时保护受试者隐私和数据机密性的独特挑战。 我们相信，这些举措不仅将改善对人类研究受试者的保护，而且还将提高IRB审查过程的效率，并促进杜克的临床研究。

Duke University Heatlh System administers over 2400 IRB protocols annually. Duke's MPA includes responsibility for investigators in three hospitals in its system and in clinic sites throughout the region. Currently, five IRBs review and monitor these protocol. Furthermore, investigators are frequently working away from their offices and need to have access to the IRB system and their protocols. Since the number of clinical trials under active IRB review continues to grow at a rapid rate, the IRB report management system at Duke must be improved and expanded. We also anticipate increased work for the IRBs associated with HIPAA implementation. In order to deal with these demands on the IRB, we must create new facilities and systems to meet our needs. Duke University Health System proposes to meet these needs through three approaches. First, the institution will increase the number of IRBs from 5 to 6. This increase in the number of IRBs and the large activity level of the current IRBs requires that we create new facilities to accommodate this level of activity. This will also require that secure space be developed for the confidential handling and storage of IRB protocols. We propose to use this support to create a secure storage unit in the new IRB office for both records and the computer server. Second, we intend to develop a secure, web based electronic IRB submission and tracking system. The system will permit the management of new protocols and those undergoing continuing review, the recording of adverse events, amendments, and audit reports, documentation of educational training and credentialing, and development of Phase 1/11data and safety monitoring plans. The elRB system will also permit more efficient communication among the conflict of interest committee, the Grants office, and the IRB. We are requesting funds to create and implement such a system. Finally, we propose to develop a training program for the users of the system which will include a module focusing on the unique challlenges of protecting subject privacy and data confidentiality when using an electronic database. We believe that these initiatives will both improve the protection of human research subjects but will also enhance the effeciency of the IRB review process and promote clinical research at Duke.