Drug Information Journal - March 2009 - (Page 164) 164 MEDICAL INFORMATION Hyveled, Karpur, Nakskov Conventional Trials FIGURE 1 Synopsis The linear process of conventional clinical trials compared to parallel processing. Protocol CRF PDBR DBR FPFV LPFV LPLV Results Parallel Processing Synopsis Protocol Processes CRF TVP PDBR PDBR PDBR DBR FPFV -DQRC LPFV LPLV Results CRF = case report form; DBR = database release; DQRC = data quality review committee; FPFV = first patient first visit; LPFV = last patient first visit; LPLV = last patient last visit; PDBR = partial database release; TVP = trial validation plan this possible. The effect is illustrated though Figure 2. The TVP (Trial Validations Plan) is constantly analyzed to search for tendencies of protocol violation or need for investigator/CRA training via the listings of discrepancies and DCFs. Blinded graphic patient profiles are utilized for illustrations and review by internal medical staff of operational data (eg, number of lab samples analyzed, events coded, etc) and FIGURE 2 Learning from data by thinking in processes. BI MCC TVP Monitoring Manual Patient Profile SEC Data Listings MCC = medical consistency checks; TVP = trial validation plan; SEC = self-evident correction aids systematic medical consistencies check by easing the process of linking data to AEs/SAEs or the lack of reporting of such events This leads to ongoing update of the monitoring manual, which leads to development and update of the self-evident corrections procedures, and the circle starts again. Adaptation of the personnel structure is needed for the New Way of Working; an example of the personnel organization implemented in a trauma study is illustrated in Figure 3. The head of Clinical Operations Trial Relations oversees the activities of the training coordinator, clinical event manager, and recruitment manager, and provides a link between these groups and Clinical Informatics. The Clinical Operations Trial Relations group coordinates the training, clinical events, and recruitment for each trial. Responsibilities include: preparing and implementing training plans and courses for site staff, CRAs, and internal staff to ensure optimal knowledge management; preparing and implementing recruitment strategies and contin-
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