Clinical Trial Project Management

Kindle Edition or EPUB + Converted PDF نویسندگان: Ashok Kumar Peepliwal
جزئیات
فرمت: Kindle Edition or EPUB + Converted PDF ناشر: Academic Press (November 15, 2023) تاریخ انتشار نسخه الکترونیکی : November 15, 2023
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شابک: 9780443136276 لینک: https://www.amazon.com/dp/B0CNGQ5PR4
توضیحات
Clinical Trial Project Management provides a detailed overview of how to conduct clinical trials, in an international context. The process of conducting clinical studies across nations is based on a set of regulatory regimes developed by respective regulatory agencies. The book focuses on clinical study protocol approval processes, Ethics Committee approval processes, clinical study feasibilities, site selection, site initiation, site monitoring, database lock, sit close-out, clinical data processing and management, SAE reporting and compensation, randomization procedure, pharmacovigilance, statistical tools, BA/BE studies, and clinical study report writing etc. covering entire clinical trial process of conductance. In addition to that the author also incorporated the clinical trial approval process of USFDA, EMA, and JAPAN to conduct the clinical trials.Covers how to conduct clinical trials in detailPresent useful, basic, and advanced statistical toolsProvides real-time project management methods like Program Evaluation Review Technique (PERT) and Critical Path Method (CPM) to manage complex projects are described in the book
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