?SAFETY OVERSIGHT AND REPORTING GROUP The Safety Oversight and Reporting Group (SORG) will provide safety oversight for the consortia included in the Allergy and Asthma Disease Group (AADG), Autoimmune Disease Group (ADG), and Transplantation Group (TG). Rho currently provides safety monitoring and oversight for all of these consortia, except for Consortium of Food Allergy Research (CoFAR) and will maintain our high quality of safety reporting activities for these consortia and CoFAR as part of this cooperative agreement. The goal of the SORG is to achieve a high-quality, standardized process for receiving, processing, following, and reporting safety information for all clinical trials conducted by the consortia. Rho proposes to achieve this goal by creating a comprehensive safety management plan that will provide structure and detailed procedures for safety oversight activities across all studies. In addition, for each protocol, a protocol-specific safety management plan will be created to outline protocol-specific requirements. The safety management plan includes description of responsibilities, how adverse events (AEs) and serious adverse events (SAEs) will be monitored, real-time notifications to DAIT and other appropriate individuals of SAEs, safety reporting workflow and timeframes for when regulatory reports will be provided for submission to maintain compliance for U.S. and non-U.S regulations and requirements, protocol-specific templates, and identification of the reference safety document for determining regulatory expectedness/listedness. Additionally, the SORG will provide input during the development of study documents such as the protocol, investigator brochure, data forms, plans, and reports to ensure AEs and SAEs are monitored appropriately. For each protocol a lead product safety monitor (PSM) will be assigned. PSMs are assigned to a specific disease group, but everyone is cross-trained to provide back-up support. The PSM will educate site staff in how to appropriately recognize, record, and report AEs and SAEs. SAE data provided by the sites will be entered by the SORG into a secure, validated database specifically for entering, tracking, coding, reporting, analyzing and archiving SAE data. The SORG will also provide support to DAIT safety oversight structures by creating thorough, high-quality safety reports and presentations and by maintaining the DSMB Portal, a centralized place for all materials, agendas, and conflict of interest information.
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