Electronic Adverse Event Reporting and Tracking System

点击翻译按钮获取中文摘要

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.