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管理层对合规的参与:当分销管理失败时,每个人都要付出代价。

Management involvement with compliance: when distributive management fails, everyone pays.

作者信息

Goldman D S

机构信息

Goldman Associates International, Inc., Gaithersburg, MD 20885-3374, USA.

出版信息

Qual Assur. 1995 Dec;4(4):288-96.

PMID:8890355
Abstract

In this article I discuss the importance of management retaining and exercising its responsibilities for control over studies, especially studies that have been distributed to contractors and subcontractors, hence the title, "Distributive Management." While the clearest examples for distributive management are found in environmental fate and crop residue studies for EPA, similar examples may be found in contemporary toxicology and carcinogenicity studies. The cost of failure to exercise control over contracted studies has been estimated by the EPA at between $600 M and $1,200 M. These are costs that will be borne by the public through higher prices and higher taxes.

摘要

在本文中,我将探讨管理层保留并履行其对研究进行控制的责任的重要性,特别是对于那些已分配给承包商和分包商的研究,因此才有了“分布式管理”这个标题。虽然分布式管理最明显的例子见于美国环境保护局(EPA)的环境归宿和作物残留研究中,但在当代毒理学和致癌性研究中也能找到类似的例子。据EPA估计,对委托研究未能实施控制所造成的成本在6亿至12亿美元之间。这些成本将由公众以更高的价格和更高的税收来承担。

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