Template protocol for clinical trials investigating vaccines Focus on safety elements
Template protocol for clinical trials investigating vaccines Focus on safety elements
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DOI：
10.1016/j.vaccine.2013.02.041
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发表时间：
2013-11-12
期刊：
影响因子：
5.5
通讯作者：
Heininger, Ulrich
中科院分区：
文献类型：
--
作者：
Bonhoeffer, Jan;Imoukhuede, Egeruan B.;Heininger, Ulrich
本文件旨在作为预防性疫苗试验方案制定的指南。该模板可用于I-IV期临床试验方案制定，以包括监管机构要求的安全性相关信息和研究者认为有用的信息。本文件也可能有助于未来的网站加强工作。(C)2013爱思唯尔有限公司保留所有权利。
This document is intended as a guide to the protocol development for trials of prophylactic vaccines. The template may serve phases I-IV clinical trials protocol development to include safety relevant information as required by the regulatory authorities and as deemed useful by the investigators. This document may also be helpful for future site strengthening efforts. (C) 2013 Elsevier Ltd. All rights reserved.