Drug Information Journal - March 2009 - (Page 165) Knowledge Innovation and Clinical Operational Excellence MEDICAL INFORMATION 165 Director CRO PM CRO DQRC Core Team PM NN Director of Clinical Operations NN FIGURE 3 Personnel organization implemented in a trauma study. DM CRO IL Information Logistic TM E EU IO US NN C CI+ NNDM NNDM ND ITM GTM Recruitment GRM Quality CTM CTM CTM CTM TM M RM RM RM LEAD CRAs CRAs Sites CI= chief investigator; CRA = clinical research associate; CRO = clinical research organization; CTM = clinical trial manager; DM = data manager; DQRC = data quality review committee; GRM = global recruitment manager; GTM = global trials manager; IL = information logistics; ITM = international trial management; NN = Novo Nordisk; PM = product manager; RM = recruitment manager; TM = trial management gency plans; and providing support and motivation for global staff within acute settings. CIG AND ISCM The Clinical Informatics Group (CIG) comprises project data managers, consultants, and information logistics managers, and is responsible for building and maintaining the information logistics center and transforming trial management input to the critical trial path to measurable tracking parameters. Hence CIG provides the bridge between medical, clinical, and data management personnel; information delivery, including participation in the data quality review committee; ensures trial data are of optimal quality; and ensures knowledge management is implemented. This real-time data-driven approach by the CIG prompts relevant actions for the trial staff. This is the essence of ISCM (Figure 4). The focus must of course be on doing the right thing, which can be very hard to predict, especially under the changing conditions previously described. Continual analysis of operational, nontherapeutic data gives some pointers toward any problematic area. As an example, Figure 5 shows discrepancies per site compared to number of patients, where the learning needs are being identified by site, taking into consideration the learning based upon the repeat of the protocol when additional patients are enrolled. Unpredictability can only be handled by nonstandard thinking and causality assessment. It is the responsibility of the Clinical Informatics Group to make these assessments and coordinate the information flow for the stakeholders. An example is the monitoring of computerized tomography (CT) scans for suspected ICH in a trial. The time consumption from each site was tracked intensively in order to identify the best performers and facilitate exchanges of Drug Information Journal
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