Glossary entry (derived from question below)
English term or phrase:
adjudicated events
German translation:
bestätigte Ereignisse/Fälle, gesicherte Fallberichte
Added to glossary by
Steffen Walter
Aug 29, 2007 19:27
17 yrs ago
15 viewers *
English term
giving as good as got
Native in: German
Works in: English to German, French to German, Spanish to German
adjudicated event
English to German
Medical
Medical (general)
pivotal study of medical device
"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?
ausgewertete Fälle/Fallgeschichten? Fallberichte?
Proposed translations
(German)
| 3 +2 | bestätigte Ereignisse/Fälle |
Gabriele Beckmann
|
Change log
Aug 29, 2007 22:01: Steffen Walter changed "Edited KOG entry" from "<a href="/profile/118209">Roland Nienerza's</a> old entry - "adjudicated event"" to ""bestätigte Ereignisse/Fälle, gesicherte Fallberichte""
Proposed translations
+2
32 mins
Gabriele Beckmann
France
France
Native in German
Specializes in field
France
Translations - and a little bit more
Native in: German
Works in: French to German, English to German
Related KudoZ points
:
140
Selected
bestätigte Ereignisse/Fälle
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...
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...
4 KudoZ points awarded for this answer.
Comment: "Danke"
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