Data and Safety Monitoring Board definition

Data and Safety Monitoring Board or “DSMB” means the independent advisory data and safety monitoring board for vosaroxin protocol [ * ], a Phase 3, Randomized, Controlled, Double-Blind, Multinational Clinical Study of the Efficacy and Safety of Vosaroxin and Cytarabine Versus Placebo and Cytarabine in Patients With First Relapsed or Refractory Acute Myeloid Leukemia (VALOR), established pursuant to the DSMB Charter.
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Data and Safety Monitoring Board. (DSMB) means an independent group of experts that advises the NHLBI and the Investigators. The primary responsibilities of the NHLBI-sponsored DSMB are to: (i) periodically review and evaluate the accumulated data of the Clinical Trial for participant safety, Clinical Trial conduct and progress, and when appropriate, efficacy; and (ii) make recommendations to NHLBI concerning the continuation, modification, or termination of the Clinical Trial.
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Data and Safety Monitoring Board. Data and Safety Monitoring Board shall mean an independent group of experts to be appointed by Novartis and Idenix for the purpose of monitoring patient safety and treatment efficacy data during an ongoing clinical trial. Any Data and Safety Monitoring Board shall (i) be managed jointly by Novartis and Idenix, (ii) have either four (4) or six (6) members, with half of the members being appointed by Idenix and the other half of the members being appointed by Novartis, and (iii) act by majority vote of its members.
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Examples of Data and Safety Monitoring Board in a sentence

  • The committees: Data and Safety Monitoring Committee (DSMC) for Phase I and II clinical trials, and the Data and Safety Monitoring Board (DSMB) for Phase III clinical trials, report to the Center’s Research Council and Institutional Review Board.

  • Please refer to: NIAID Principles for Use of a Data and Safety Monitoring Board (DSMB) For Oversight of Clinical Trials Policy.

  • Data and Safety Monitoring Board – an independent committee charged with reviewing safety and trial progress and providing advice with respect to study continuation, modification, and termination.

  • The committees: Data and Safety Monitoring Committee (DSMC) for Phase I and II clinical trials, and the Data and Safety Monitoring Board (DSMB) for Phase III clinical trials, report to the Center’s Research Council and Institutional Review Board.During the protocol development and review process, each protocol will be assessed for its level of risk and degree of monitoring required.

  • This description should include information regarding an independent Data and Safety Monitoring Board (DSMB), if one exists, or an explanation why an independent data safety monitor is not necessary.

  • Data and Safety Monitoring Board oversight is not planned for this study.

  • Working committees include but are not limited to the Data and Safety Monitoring Board (DSMB), Steering Committee and Executive Committee.

  • An independent Data and Safety Monitoring Board (DSMB) chartered by NIAID/DAIDS provides oversight of ongoing Phase IIB and Phase III MTN studies.

  • Safety oversight will be under the direction of a Data and Safety Monitoring Board (DSMB) composed of individuals with the appropriate expertise.

  • These summaries will be available for inspection when requested by any of the regulatory bodies charged with the safety of human subjects and the integrity of data including, but not limited to, the oversight (Office of Human Research Ethics (OHRE) Biomedical IRB, the Oncology Protocol Review Committee (PRC) or the North Carolina TraCS Institute Data and Safety Monitoring Board (DSMB).


More Definitions of Data and Safety Monitoring Board

Data and Safety Monitoring Board means 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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Data and Safety Monitoring Board. (DSMB) means an independent group of experts that advises the NIAID and the Investigators. The primary responsibilities of the DSMB are: (i) to periodically review and evaluate the accumulated data of the Clinical Trial for participant safety, Clinical Trial conduct and progress, and when appropriate, efficacy; and (ii) to make recommendations to NIAID concerning the continuation, modification, or termination of the Clinical Trial. NIAID Extramural Clinical Trial Agreement DMID Protocol # 20-0013 Humanigen - DMID CTA Version 1.0, July 22, 2020 “Data Coordination Center” (DCC) means an organization funded by the NIAID that receives, reviews and performs data management tasks on the individual Human Subject Case Report Forms completed for this Clinical Trial. The Data Coordination Center for this Clinical Trial is Social & Scientific Systems, Inc.
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Data and Safety Monitoring Board means an independent monitoring board established by Licensee to assess at intervals the progress of a clinical trial, including the safety [***]Confidential Information, indicated by [***], has been omitted by this filing and filed separately with the Securities and Exchange Commission. data and the critical efficacy endpoints, and to recommend to Licensee whether to continue, modify, or stop a trial.
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Data and Safety Monitoring Board or “DSMB” means an independent board set up specifically to review and monitor data throughout the duration of a Clinical Study and for making recommendations concerning the continuation, modification and termination of the study as it is being conducted.
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Data and Safety Monitoring Board means an independent board that is appointed in accordance with rule 12;
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Related to Data and Safety Monitoring Board

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  • Quality Assurance Plan or “QAP” shall have the meaning set forth in Clause 11.2;

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