Drug Information Journal - March 2009 - (Page 132) 132 MEDICAL INFORMATION Cohen FIGURE 1 High-level view of the clinical research knowledge network during study startup. Shown are a fraction of the people and information conveyances needed to start and operate a typical clinical study. PRC, protocol review committee; CRO, contract research organization; CRA, clinical resesarch administrator; ICD, informed consent document; CMC, chemistry, manufacturing, and controls; CT, clinical trial; IVRS, interactive voice response system; SAP, statistical analysis plan; CRF, case report form; EDC, electronic data capture; CTMS, clinical trial management system; CDM, clinical data management; AERS, adverse event reporting system. Resource AllocationBudgeting Strategy Committee Synopsis Writers Stage Gate Committee CRA/Study Mgr Full Protocol Writers CMC-CT Supplies IVRS, Adaptive Design Planning Statistical Programming PRC Scientific Contributors CRA/Study Manager/ Outsourcing Site Assessment, Initiation, Training ICD CRO & Lab Feasibility, Site Identification Investigator/CRO Budget-Contract Ethical Reviews Regulatory Reviews SAP Writers Regulatory Data Managers CRF, EDC, CTMS, CDM, Registries, AERS ministrative assistance for knowledge workers, such as the following: • Word processors and related applications (eg, spreadsheets) shape the form of conveyed information. • Email speeds dissemination of information. • Collaboration portals encourage explicit communication. • Document management systems provide efficient storage and security of written information. the power of computers must be harnessed to operate in the areas of knowledge transfer where it does not today. KNOWLEDGE TRANSFER INEFFICIENCIES IN THE D O C U M E N T- C E N T R I C C L I N I C A L RESEARCH ENVIRONMENT The contemporary clinical research environment is strongly document-centric. Preformatted documents, such as text reports, slide presentations, spreadsheets, and so on, are used as the primary conveyances of research knowledge. Substantial effort is spent specifying document formats, creating documents, and storing and reusing documents to retrieve, use, and reuse the information contained within them. Information technologies as used today facilitate more geographically dispersed and more complex studies than were feasible previously but, as alluded to above, they fall short in terms of using and reusing information efficiently and effectively. No matter how quickly documents can be distributed among research personnel, when they reach their intended targets, they must be read and interpreted in order to be used. Therefore, unstructured documents allow Computers have not typically helped researchers communicate information unambiguously; information must be reinterpreted at every information use and reuse juncture. They also have not been particularly useful for interrelating information that spans functional areas (knowledge domains), necessitating constant supervision of newly created documents by knowledge domain experts. Because of these two limitations, computers have also played only a supporting role in propagating knowledge over time—transferring knowledge from domain experts to novices—the institutionalization of which is the basis of organizational memory (5,6). It is hypothesized that for the clinical research knowledge network to operate most efficiently,
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