Site management organisations

More trials, with greater numbers of subjects, necessitate utilisation of outside consultants and contract research organisations to manage sites, collect and verify data, assure protocol compliance plus adherence to GCP regulations. The number of outside companies who draw their livelihood from the growing size and complexity of the drug development process is itself an ominous portent. 

OECD. No. 13 The Application of the OECD Principles of GLP to the Organisation and Management of Multi-site Studies, http //www.olis.oecd.org/olis/2002doc. nsf/LinkTo/env-jm-mono (2002) 9... 

The Application of the OECD Principles of GLP to the Organisation and Management of Multi-Site Studies (2002). 

Over 80 per cent of member sites now operate health, safety and environmental management systems. Self assessment against the Association s systems is now something all of our members carry out. A small number of sites also have these systems verified by external organisations our aim is to increase the level of external verification.34... 

Such a situation might therefore put an additional strain on the different Quality Assurance units concerned. Consequently, it has to be ascertained that, irrespective of where the test sites are located, the written reports of Quality Assurance personnel must reach both test facility management and the Study Director. In other circumstances, where there may be no direct, organisational connection between the different parties concerned, i.e., in... 

The polarised safe/unsafe of the legislative lexicon has unsurprisingly become embedded in organisational safety management practices and safety management systems. Binary evaluations of safety are therefore also found at the heart of various safety management activities, such as risk assessments and site inspections, and so have considerable influence on the construction of safety in practice. 

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