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data and safety monitoring board

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Administration of clinical trial data and safety monitoring boards
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The independent body of international experts - the Data and Safety Monitoring Board – that conducted the review, advised that the trial should continue.
Quiero que me dejes ayudarte.- ¿ Ayudarme?WHO WHO
The independent body of international experts that conducted the review — the data and safety monitoring board — advised that the trial should continue.
Salvo disposición en contrario del presente Reglamento, deben aplicarse el Reglamento (CE) no #/# de la Comisión, de # de junio de #, por el que se establecen disposiciones comunes de aplicación del régimen de certificados de importación, de exportación y de fijación anticipada para los productos agrícolas, y el Reglamento (CE) no #/# de la Comisión, de # de agosto de #, por el que se establecen normas comunes de gestión de los contingentes arancelarios de importación de productos agrícolas sujetos a un sistema de certificados de importaciónUN-2 UN-2
Partners have established an independent Data and Drug Safety Monitoring Board to assess the progress, safety data and critical efficacy end points of the study.
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The interim data from the ongoing Uganda and Kenya trials were reviewed in June 2006 by the Data and Safety Monitoring Board (DSMB), which recommended that the studies continue on the grounds that there were not yet enough data to draw firm conclusions.
Condenado., se sustituye por el texto siguienteWHO WHO
Finally the measures proposed to protect the paediatric population during development for example the use of less invasive methods, use of a data and safety monitoring board for certain studies, and issues related to the feasibility of the proposed studies (e.g. recruitment or quantity of blood sampling compared to blood volume) should be discussed.
¡ Lo siento dentro de mí!EurLex-2 EurLex-2
Finally the measures proposed to protect the paediatric population during development for example the use of less invasive methods, use of a data and safety monitoring board for certain studies, and issues related to the feasibility of the proposed studies (e.g. recruitment or quantity of blood sampling compared to blood volume) should be discussed
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Independent Data Monitoring Committee (IDMC) / Data and Safety Monitoring Board (DSMB) / Monitoring Committee / Data Monitoring Committee: An independent data monitoring committee that may be established by the sponsor to assess at intervals the progress of a clinical trial, the safety data, and the critical efficacy endpoints, and to recommend to the sponsor whether to continue, modify, or stop a trial.
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Unblinded information should only be accessible to those who need to be involved in the safety reporting to national competent authorities (be it directly or indirectly through EVCTM), Ethics Committees and Data Safety Monitoring Boards (‘DSMB’) (61), or persons performing ongoing safety evaluations during the trial.
La prestación de servicios por ponentes o expertos se regirá por un contrato escrito entre la Agencia y la persona interesada o, en su caso, entre la Agencia y el empresario de dicha personaEurLex-2 EurLex-2
Geneva - The Joint United Nations Programme on HIV/AIDS and its Cosponsors, WHO, UNFPA, UNICEF and the World Bank, note with considerable interest today’s announcement by the US National Institutes of Health that two trials assessing the impact of male circumcision on HIV risk are being stopped on the recommendation of the NIH Data Safety and Monitoring Board (DSMB).
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Data and Safety Monitoring Boards (DSMBs)
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Data and Safety Monitoring Boards (DSMBs) for phase 3 trials
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Some studies have a Data and Safety Monitoring Board that regularly monitors safety.
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In November, 2016, the data and safety monitoring board recommended early reporting of the results because of safety concerns.
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Some clinical trials - especially phase III clinical trials, which often involve many institutions - use a Data and Safety Monitoring Board (DSMB).
El director ejecutivo facilitará al consejo de administración cualquier otra información complementaria que necesite a tal efectoParaCrawl Corpus ParaCrawl Corpus
The independent body of international experts - the Data and Safety Monitoring Board — that conducted the review, advised that the trial should continue.
Les certificados de importación de arroz Basmati solicitados antes del # de septiembre de # en virtud de dicho Reglamento seguirán siendo válidos y los productos importados mediante esos certificados se acogerán al derecho de importación contemplado en el apartado # del artículo # del presente ReglamentoParaCrawl Corpus ParaCrawl Corpus
After 67 participants had completed 6 months of treatment, the trial’s data and safety monitoring board recommended that the study stop enrolling patients.
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Independent medical monitoring for safety review meetings and participation in Independent Data Monitoring Committee (IDMC) and Data Safety Monitoring Board (DSMB)
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According to the data and safety monitoring board's recommendation, the outcome has been disclosed to all patients participating in the study and their physicians.
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For smooth functioning of multiple study sites across countries, a project scientific committee (PSC), two independent bodies, an ethics board (EB) and the data safety monitoring committee (DSMC) were established.
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The data and safety monitoring board overseeing the trial, known as E1912, recommended that these results be released immediately given their significance to public health.
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The Madrid-headquartered firm's Noscira unit has received the conclusions of the third data and safety monitoring board meeting for the Phase II ARGO trial.
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After 2 years, the data and safety monitoring board recommended discontinuation of the study treatment in patients with a history of stroke owing to the risk of intracranial hemorrhage.
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To ensure the ongoing safety and monitoring of the participants in the trial, data will be reviewed by an independent Data and Safety Monitoring Board organized by NIAID throughout the study.
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The independent board (in Europe: Study Advisory Board; in US: Data and Safety Monitoring Board) is obliged to immediately terminate the study, if based on new information the benefits no longer significantly outweigh the risks for the patients.
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