Electronic Adverse Event Reporting and Tracking System

电子不良事件报告和跟踪系统

• 批准号: 6778019
• 负责人: STEPHEN R MITCHELL
• 金额: $ 15万
• 依托单位: GEORGETOWN UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2002
• 资助国家: 美国
• 起止时间: 2002-09-01 至 2005-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6778019
• 关键词: automated health care system; cancer information system; health science research; health science research support; patient safety /medical error; training

The initial Georgetown University (GU) HSREP project launched development of electronic support systems for a newly created Joint Oncology IRB, which reviews cooperative oncology research conducted by Georgetown University (GU) and MedStar Research Institute (MRI). MedStar Health System (MedStar) maintains 25 integrated health care facilities in the Baltimore-Washington area (including Georgetown University Hospital (GUH) and the six other major hospitals), conducts its own program of research in non-GU facilities, and does not currently receive HSREP support. MRI is the wholly-owned subsidiary of MedStar which focuses on clinical research within MedStar. During the past year, the GU HSREP project has supported the GU-MRI Oncology IRB through (i) on-site, interactive training sessions; (ii) development and beta testing of a Computerized Adverse Event Reporting system (CAER); and (iii) planning for a Computerized IRB Protocol Support System (CIPSS). CAER not only provides for real-time electronic submission, tracking, and cross-protocol integration of AEs, but also provides IRB reviewers with algorithms for triaging AE reports, determining their seriousness, and identifying options for IRB action. When fully implemented, CAER will support electronic submission of AE reports; integration of AE reports with existing electronic pharmacy records; facilitation of causation analysis; and automatic transmission of Serious Adverse Event (SAE) reports to relevant federal agencies, including the Food and Drug Administration (FDA), the Office for Human Research Protections (OHRP), and the NIH Office of Biotechnology Activities (OBA). CIPSS will be a totally electronic IRB support system that includes electronic protocol submission and tracking; routing of protocols and reviewer comments to IRB members; compilation of IRB meeting minutes; transmission of modification requirements and continuing review notices to investigators; and integration of AE reports through CAER. The enhancements proposed in the current application have the following four specific aims, whose benefits will be shared with MedStar and its non-GUH facilities, which do not currently receive HSREP support: (1) To implement CAER in support of the GU-MRI Oncology IRB. (2) To develop and implement CIPSS in support of the GU-MRI Oncology IRB. (3) To extend CAER-CIPSS to include (a) research conducted through the GU General Clinical Research Center (GCRC) Pediatric Satellite at the Children's National Medical Center; and (b) all other research reviewed by the five additional GU-MRI IRBs (specifically, two GU Medical IRBs, one GU Social/Behavioral IRB, one MRI IRB in Washington, one MRI IRB in Baltimore). (4) To expand CAER-CIPSS to include AEs from all GUMC and MedStar clinical services, thus providing the six IRBs with integrated information on all AEs occurring in, or reported to, all GUH and all other MedStar facilities throughout the Washington-Baltimore area. The project will also support human subject protection training resources and training for IRB members, staff and research investigators. Training materials will be retained for use after the project has been completed. Effectiveness of enhancement activities will be evaluated through self-report user surveys that include both structured and open-ended questions.

最初的乔治城大学（GU）HSREP项目启动了新创建的联合肿瘤学IRB的电子支持系统的开发，该IRB负责审查乔治城大学（GU）和MedStar研究所（MRI）进行的合作肿瘤学研究。MedStar Health System（MedStar）在巴尔的摩-华盛顿地区（包括乔治敦大学医院（GUH）和其他六家主要医院）拥有25家综合医疗保健设施，在非GU设施中开展自己的研究计划，目前不接受HSREP支持。MRI是MedStar的全资子公司，专注于MedStar内部的临床研究。 在过去的一年中，GU HSREP项目通过（i）现场互动培训课程;（ii）计算机化不良事件报告系统（CAER）的开发和beta测试;以及（iii）计算机化IRB方案支持系统（CIPSS）的规划支持了GU-MRI肿瘤学IRB。 CAER不仅提供了AE的实时电子提交、跟踪和跨方案整合，还为IRB审查员提供了分类AE报告、确定其严重性和确定IRB行动选项的算法。全面实施后，CAER将支持AE报告的电子提交; AE报告与现有电子药房记录的整合;促进因果关系分析;以及将严重不良事件（SAE）报告自动传输至相关联邦机构，包括食品药品监督管理局（FDA）、人类研究保护办公室（OHRP）和NIH生物技术活动办公室（OBA）。 CIPSS将是一个完全电子化的IRB支持系统，包括电子方案提交和跟踪;将方案和审查员意见发送给IRB成员;汇编IRB会议记录;将修改要求和持续审查通知发送给研究者;以及通过CAER整合AE报告。 当前申请中提出的增强功能具有以下四个具体目标，其益处将与MedStar及其非GUH机构共享，这些机构目前未获得HSREP支持： (1)实施CAER以支持GU-MRI肿瘤学IRB。 (2)制定和实施CIPSS，以支持GU-MRI肿瘤学IRB。 (3)扩展CAER-CIPSS，以包括（a）通过国家儿童医学中心的GU综合临床研究中心（GCRC）儿科卫星开展的研究;以及（B）由五个额外的GU-MRI IRB（具体而言，两个GU医学IRB、一个GU社会/行为IRB、一个华盛顿的MRI IRB、一个巴尔的摩的MRI IRB）审查的所有其他研究。 (4)扩展CAER-CIPSS，以纳入所有GUMC和MedStar临床服务的AE，从而为六个IRB提供关于在华盛顿-巴尔的摩地区所有GUH和所有其他MedStar机构发生或报告的所有AE的综合信息。 该项目还将支持人类受试者保护培训资源，并为IRB成员、工作人员和研究者提供培训。培训材料将保留，供项目完成后使用。将通过自我报告的用户调查，包括结构化和不限成员名额的调查，评估增强活动的效果。 问题.