In clinical trials, source data verification, or SDV, is the process of validating source data, which is defined by the ICH GCP as “all information in original records and certified copies of original records of clinical findings, observations, or other
Nicole Sheetz等在2014年九⽉份发表了⼀篇题为《Evaluating Source Data Verification as a Quality Control Measure in Clinical Trials》。该研究共涉及到53个申办⽅的1168个临床试验，从I期到IV期，⽤详实的数据来分析SDV在临床试验中对于质量的贡献率。其中稽查部分的统计数据如下：在1376个critical 或者major...
我们可以尝试换一个角度去看待SDV:大家对SDV比例高低的要求,无非取决于对临床试验质量的要求,那么问题来了:SDV对于临床实验质量会有多大的贡献,兴许我们可以从这篇文献中找到一些答案。 Nicole Sheetz等在2014年九月份发表了一篇题为《Evaluating Source Data Verification as a Quality Control Measure in Clinical Tria...
我们可以尝试换一个角度去看待SDV:大家对SDV比例高低的要求,无非取决于对临床试验质量的要求,那么问题来了:SDV对于临床实验质量会有多大的贡献,兴许我们可以从这篇文献中找到一些答案。 Nicole Sheetz等在2014年九月份发表了一篇题为《Evaluating Source Data Verification as a Quality Control Measure in Clinical Tria...
doi:http://www.appliedclinicaltrialsonline.com/appliedclinicaltrialsOver the past year and a half we have been monitoring the trend towards adoption of risk-based monitoring across the industry, and in particular the move towards r...
AtArtificial Intelligence - Search, Data and Text Mining, Analytics and Visualization (AI-SDV), learn how our BizInt Smart Charts product family applies advanced text analytics and expert knowledge to create reports and visualizations from patent, drug pipeline, and clinical trials databases. ...
To support this communication plan,Bristol-Myers Squibb has put in place a system that will enable the company to deliver these educational materials to the appropriate healthcare professional at the time of product order.YERVOY Was Studied in a Pivotal Phase 3 Clinical Trial of Patients with ...
To support this communication plan,Bristol-Myers Squibb has put in place a system that will enable the company to deliver these educational materials to the appropriate healthcare professional at the time of product order.YERVOY Was Studied in a Pivotal Phase 3 Clinical Trial of Patients with ...
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The safety of Mozobil in pregnant women has not been established in clinical trials.If you are of childbearing potential you should be advised to avoid becoming pregnant while receiving treatment with Mozobil. If this drug is used during pregnancy, or if you become pregnant while taking this ...