English to German translations [PRO]
Medical - Medical (general) / pivotal study of medical device | | English term or phrase: adjudicated event | "On regular and predefined time points, the sponsor will provide baseline characteristics and the data available at that point in time, including the ***adjudicated events***, to an independent safety and monitoring board -"
ausgewertete Fälle/Fallgeschichten? Fallberichte? |
|  Roland NienerzaKudoZ activityQuestions: 103 (none open) ( 1 without valid answers) ( 11 closed without grading) Answers: 685
Germany
| | Local time: 07:07
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| | bestätigte Ereignisse/Fälle | Explanation:
durch ein unabhängiges "Safety Endpoint Adjudication Committee" bestätigte Ereignisse/Fälle
The use of an Endpoint Assessment and Adjudication Committee in industry-sponsored pivotal clinical trials is a relative novelty, but one of great import to stakeholders in the clinical research and development arena. By making use of an Endpoint Assessment and Adjudication Committee, a sponsor can expect adjudicated clinical trial data that better represent the actual efficacy of the drug under study, and that are less likely to be questioned by the FDA at the time of a license application. This can be very important to companies interested in making sound decisions about continuing or terminating specific development programs.
http://findarticles.com/p/articles/mi_qa3899/is_200501/ai_n1...
An independent Safety Endpoint Adjudication Committee (SEAC) reviewed and adjudicated, while blinded, all potential cases of IT as they occurred. The Data and Safety Monitoring Board (DSMB) unblinded the treatment arm of positively-adjudicated (confirmed) cases and made recommendations for continuing the study based on predefined safety boundaries as well as clinical judgment.
http://www.fda.gov/OHRMS/DOCKETS/AC/05/briefing/5-4198B1_2.p...
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| Selected response from:
Gabriele Beckmann
Local time: 07:07
| Grading comment Danke
4 KudoZ points were awarded for this answer |
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| Discussion entries: 0 |
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Automatic update in 00:
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32 mins confidence:   peer agreement (net): +2 bestätigte Ereignisse/Fälle
Explanation:
durch ein unabhängiges "Safety Endpoint Adjudication Committee" bestätigte Ereignisse/Fälle
The use of an Endpoint Assessment and Adjudication Committee in industry-sponsored pivotal clinical trials is a relative novelty, but one of great import to stakeholders in the clinical research and development arena. By making use of an Endpoint Assessment and Adjudication Committee, a sponsor can expect adjudicated clinical trial data that better represent the actual efficacy of the drug under study, and that are less likely to be questioned by the FDA at the time of a license application. This can be very important to companies interested in making sound decisions about continuing or terminating specific development programs.
http://findarticles.com/p/articles/mi_qa3899/is_200501/ai_n1...
An independent Safety Endpoint Adjudication Committee (SEAC) reviewed and adjudicated, while blinded, all potential cases of IT as they occurred. The Data and Safety Monitoring Board (DSMB) unblinded the treatment arm of positively-adjudicated (confirmed) cases and made recommendations for continuing the study based on predefined safety boundaries as well as clinical judgment.
http://www.fda.gov/OHRMS/DOCKETS/AC/05/briefing/5-4198B1_2.p...
| Gabriele Beckmann
Local time: 07:07
Specializes in field
Native speaker of:  German
PRO pts in category: 128
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| Changes made by editors |
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| Aug 29, 2007 - Changes made by Steffen Walter: | | Edited KOG entry | Roland Nienerza's old entry - "adjudicated event" => "bestätigte Ereignisse/Fälle, gesicherte Fallberichte" |
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