2 resultados para Industrial safety committees

em CORA - Cork Open Research Archive - University College Cork - Ireland


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This paper discusses the difficulties involved in managing knowledge-intensive, multinational, multiorganisational, and multifunctional project networks. The study is based on a 2-year quasi-ethnography of one such network engaged in the design and development of a complex new process control system for an existing pharmaceutical plant in Ireland. The case describes how, drawing upon the organisational heritage of the corporations involved and the logic implicit within their global partnership arrangements, the project was initially structured in an aspatial manner that underestimated the complexity of the development process and the social relations required to support it. Following dissatisfaction with initial progress, a number of critical management interventions were made, which appeared to contribute to a recasting of the network ontology that facilitated the cultivation and protection of more appropriate communicative spaces. The case emphasises the need to move away from rationalistic assumptions about communication processes within projects of this nature, towards a richer conceptualisation of such enterprises as involving collective sensemaking activities within and between situated ‘communities’ of actors. Contrary to much contemporary writing, the paper argues that space and location are of crucial importance to our understanding of network forms of organising.

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Aim: To evaluate the reported use of Data Monitoring Committees (DMCs), the frequency of interim analysis, pre-specified stopping rules and early trial termination in neonatal randomised controlled trials (RCTs). Methods: We reviewed neonatal RCTs published in four high impact general medical journals, specifically looking at safety issues including documented involvement of a DMC, stated interim analysis, stopping rules and early trial termination. We searched all journal issues over an 11-year period (2003-2013) and recorded predefined parameters on each item for RCTs meeting inclusion criteria. Results: Seventy neonatal trials were identified in four general medical journals: Lancet, New England Journal of Medicine (NEJM), British Medical Journal and Journal of American Medical Association (JAMA). 43 (61.4%) studies reported the presence of a DMC, 36 (51.4%) explicitly mentioned interim analysis; stopping rules were reported in 15 (21.4%) RCTs and 7 (10%) trials were terminated early. The NEJM most frequently reported these parameters compared to the other three journals reviewed. Conclusion: While the majority of neonatal RCTs report on DMC involvement and interim analysis there is still scope for improvement. Clear documentation of safety related issues should be a central component of reporting in neonatal trials involving newborn infants.