How to Avoid US FDA Warning Letters in Clinical Studies-Michael Rosenberg explains how adaptive monitoring can be a better way of tracking investigative site quality and performance.

Michael Rosenberg

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How to Avoid US FDA Warning Letters in Clinical Studies-Michael Rosenberg explains how adaptive monitoring can be a better way of tracking investigative site quality and performance.

机译：如何避免临床研究中的美国FDA警告信-Michael Rosenberg解释了自适应监视如何成为跟踪调查站点质量和性能的更好方法。

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You never thought it possible: the clinical trial under your organisation's management is coming under fire for inadvertently overdosing paediatric patients for 20 days running. How could this have happened to you? You would never tolerate any practice that could lead to such a result. From protocol development to assignment of monitors and investigative site visits, you had insisted on close adherence to standard industry practices. You had budgeted for an ample number of monitors and site visits, and the visits had taken place.

机译：您从未想到过这样的可能性：您组织的管理下的临床试验由于连续20天无意中给小儿患者服用过量而备受争议。你怎么会这样您永远不会容忍任何可能导致这种结果的做法。从协议开发到监视器分配和调查现场访问，您一直坚持严格遵守标准行业惯例。您已经为大量的监视器和站点访问进行了预算，并且访问已经进行。

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《The regulatory affairs journal: Pharma》 |2010年第8期|共6页
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Michael Rosenberg;
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入库时间 2022-08-18 18:58:12

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1. How to Avoid US FDA Warning Letters in Clinical Studies-Michael Rosenberg explains how adaptive monitoring can be a better way of tracking investigative site quality and performance. [J] . Michael Rosenberg The regulatory affairs journal: Pharma . 2010,第8期

机译：如何避免临床研究中的美国FDA警告信-Michael Rosenberg解释了自适应监视如何成为跟踪调查站点质量和性能的更好方法。
2. Avoid an FDA Warning Letter in the Laboratory Environment [J] . Richard Aleman Controlled Environments Magazine . 2016,第5期

机译：在实验室环境中避免使用FDA警告信
3. Avoid An FDA Warning Letter: A Compliance Tool For Cosmetic Claims [J] . The Rose Sheet:Toiletries Fragrances and Skin Care Group The Rose Sheet: Toiletries, Fragrances and Skin Care . 2016,第Auga30期

机译：避免使用FDA警告信：化妆品声明的合规工具
4. Anti-483 Forum: How to Avoid an FDA Early Warning Letter Panel Discussion [C] . Leslie Osmera Annual Technical Meeting and Exposition of the Institute of Environmental Sciences and Technology;EDUCON Conference . 2020

机译：ANT-483论坛：如何避免FDA早期警告信面板讨论
5. C1-4: Preparing for FDA Bioresearch Monitoring (BIMO) and Good Clinical Research Practice (GCP) Inspections: Fundamentals for KP Clinical Trial Sites [O] . Nanette Hock 2013

机译：C1-4：为FDA生物研究监测（BIMO）和良好临床研究实践（GCP）检查做准备：KP临床试验场所的基础
6. Guidance on responding to FDA Warning Letters and possible enforcement consequences for clinical investigators and sponsors [O] . James P. Walters 2004

机译：关于回应FDA警告信和临床调查员和赞助商可能的执法后果的指导

How to Avoid US FDA Warning Letters in Clinical Studies-Michael Rosenberg explains how adaptive monitoring can be a better way of tracking investigative site quality and performance.

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