One year on:what has been the impact of the clinical trials directive?

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One year on:what has been the impact of the clinical trials directive?

机译：一年：临床试验指令产生了什么影响？

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After a background paper on the development and the requirements of the clinical trials directive (CTD) by Brian Davis of the Medicines and Healthcare products Regulatory Agency,the feedback from the regulators was presented.Bronwyn Phillips,an MHRA inspector,explained that from 1 May 2004 the voluntary programme of inspection had ceased.Around 175 applications have since been received,the majority (120) from existing licensed sites.

机译：在药品和保健产品监管局的Brian Davis撰写了有关临床试验指令（CTD）的发展和要求的背景文件后，提出了监管者的反馈意见。MHRA检查员布朗温·菲利普斯（Bronwyn Phillips）解释说，从5月1日开始2004年，自愿检查计划已经停止。自那时以来，已收到大约175份申请，其中大部分（120）来自现有的许可站点。

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《The pharmaceutical journal》 |2005年第7351期|共1页
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1. One year on:what has been the impact of the clinical trials directive? [J] . The Pharmaceutical Journal Group The pharmaceutical journal . 2005,第7351期

机译：一年：临床试验指令产生了什么影响？
2. Impact of the European clinical trials directive on prospective academic clinical trials associated with BMT. [J] . Frewer LJ, Coles D, van der Lans IA, Bone marrow transplantation . 2011,第3期

机译：欧洲临床试验指令对与BMT相关的前瞻性临床试验的影响。
3. '(More) trials and tribulations': the effect of the EU directive on clinical trials in intensive care and emergency medicine, five years after its implementation. [J] . Robinson K, Andrews PJ Journal of medical ethics . 2010,第6期

机译：“（更多）试验和磨难”：实施后五年，欧盟指令对重症监护和急诊医学临床试验的影响。
4. Evaluating the impact of clinical trials on-line on clinical trial awareness and accrual [C] . Stahl, D.C., Stahl, . 2000

机译：评估在线临床试验对临床试验意识和应计费用的影响
5. A prospective randomized clinical trial to assess the performance of microtextured dental implants with or without a machined collar – 1 year results [D] . Randall, Elizabeth Felts 2015

机译：一项前瞻性随机临床试验，用于评估带或不带机加工项圈的微纹理牙科植入物的性能-一年的结果
6. Impact assessment of the European Clinical Trials Directive: a longitudinal prospective observational study analyzing patterns and trends in clinical drug trial applications submitted since 2001 to regulatory agencies in six EU countries [O] . Markus Hartmann 2012

机译：欧洲临床试验指令的影响评估：一项纵向前瞻性观察性研究分析自2001年以来提交给六个欧盟国家监管机构的临床药物试验申请的方式和趋势
7. Impact assessment of the European Clinical Trials Directive: a longitudinal, prospective, observational study analyzing patterns and trends in clinical drug trial applications submitted since 2001 to regulatory agencies in six EU countries [O] . Markus Hartmann 2012

机译：欧洲临床试验指令的影响评估：一项纵向，前瞻性，观察性研究，分析自2001年以来提交给六个欧盟国家监管机构的临床药物试验申请的方式和趋势
8. Health and Cost Impacts of a Maternal-Child Advocacy Program: Outcomes at TwelveMonths. A Clinical Trial Evaluating the REACH-Futures Program. Abstract. Executive Summary and Final Report [R] . Norr, K. F., Crittenden, K. S., Reyes, O., 1998

机译：母婴宣传计划对健康和成本的影响：十二个月的结果。评估REaCH-期货计划的临床试验。抽象。执行摘要和最终报告

One year on:what has been the impact of the clinical trials directive?

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