Research Project Management on Clinical Trials-1

S. Alsuwaidan
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Abstract

The scenario of this project came from amalgamation of both good clinical practice (GCP) the project management for professional (PMP); since all research studies and clinical trials are considered as research project then we have to prepare and formulate a “Research Manager” for research projects with specific job description for what are the steps to follow to get a successful and completed clinical trials. In-fact, writing this book depends on two main references articles namely: “A guide to the project management body of knowledge: (PMBOK guide)” project management for professional and “Clinical Trials Requirement Guideline (version 1.3)”, Drug sector, Saudi Food and Drug Authority, Kingdom of Saudi Arabia.
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临床试验研究项目管理-1
这个项目的场景来自于良好临床实践(GCP)和专业项目管理(PMP)的合并;由于所有的研究和临床试验都被认为是研究项目,那么我们必须为研究项目准备和制定一个“研究经理”,并提供具体的工作描述,说明成功完成临床试验的步骤。事实上,撰写本书依赖于两篇主要参考文章,即:“项目管理知识体系指南(PMBOK指南)”专业项目管理和“临床试验要求指南(1.3版)”,沙特阿拉伯王国沙特食品和药物管理局药品部门。
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