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临床研究部门的标准操作程序。

Standard operating procedures for clinical research departments.

作者信息

Kee Ashley Nichole

机构信息

BMKConsultants, 1611 Carroll Avenue, #1, Saint Paul, MN 55104, USA.

出版信息

J Med Pract Manage. 2011 Nov-Dec;27(3):172-4.

Abstract

A set of standard operating procedures (SOPs) provides a clinical research department with clear roles, responsibilities, and processes to ensure compliance, accuracy, and timeliness of data. SOPs also serve as a standardized training program for new employees. A practice may have an employee that can assist in the development of SOPs. There are also consultants that specialize in working with a practice to develop and write practice-specific SOPs. Making SOPs a priority will save a practice time and money in the long run and make the research practice more attractive to corporate study sponsors.

摘要

一套标准操作规程(SOP)为临床研究部门提供了明确的角色、职责和流程,以确保数据的合规性、准确性和及时性。SOP还可作为新员工的标准化培训计划。医疗机构可能有一名员工能够协助制定SOP。也有专门与医疗机构合作制定和编写特定于该机构的SOP的顾问。从长远来看,将SOP作为优先事项将为医疗机构节省时间和金钱,并使研究机构对企业研究赞助商更具吸引力。

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