?CLINICAL SITE MONITORING GROUP The Clinical Site Management Group (CSMG) will provide clinical site monitoring support for the consortia included in the Allergy and Asthma Disease Group (AADG), Autoimmune Disease Group (ADG), and Transplantation Group (TG) except for the Immune Tolerance Network (ITN), which is handled by a different contract. Rho currently provides a robust on-site and centralized site monitoring strategy for all of these consortia, except for Consortium of Food Allergy Research (CoFAR) and will maintain our high quality of monitoring activities for these consortia and CoFAR as part of this cooperative agreement. The goal of the CSMG is to achieve effective monitoring and site management for all clinical trials conducted by the consortia included in the AADG, ADG, and TG. Rho proposes to achieve this goal through a combination of on-site visits, interim monitoring calls, remote/centralized data review, and in-house management conducted by clinical research associates (CRAs), study managers and/or other DAIT statistical and clinical coordinating center (Center) staff. Due to the specific requirements of different disease areas and their population/study and research focus needs, each disease group will create a clinical monitoring plan which will provide guidelines for site monitoring visits and centralized monitoring strategies, as well as plans for training, activation, and management of sites participating in the Center's trials. In addition, for each protocol, the Center will create a study-specific addendum to the network plan, which provides trial-specific work instructions, and references to trial-specific procedures, forms, documents, materials and guidelines. The primary purpose of these monitoring plans will be to serve as a resource for and provide standardized structure to CRAs, study managers and other Center staff. Centralized monitoring practices will be in place for each trial in order to supplement periodic on- site visits or phone contact. This allows issues or trends (both site and protocol specific) to be proactively identified. Following each on-site visit or call, the CRA will document the visit in a written trip report. The report describes the activities completed by CRA and site personnel, any issues identified during the visit/call and actions taken to correct deficiencies. Routine, non-serious issues will generally be resolved by the CRA or other Center team members in collaboration with the site staff. If site performance or regulatory compliance issues of significant concern are identified through on-site activities, centralized monitoring activities, or by a DAIT team member, a for-cause visit and/or audit may be recommended and completed by Rho staff. If it is determined that a for-cause visit is not needed, Rho staff and DAIT-NIAID Project Management may work with the site through phone calls, additional trainings, and email to resolve the issues. Rho will continue to leverage its experience in allergy, asthma, autoimmune, and transplantation trials and existing relationships with the study sites in order to monitor and manage sites effectively.
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