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. 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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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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Examples of Data and Safety Monitoring Board in a sentence

  • However, NIH may decide to establish an independent Data and Safety Monitoring Board (DSMB) depending on the scope and risk of the trial.

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

  • Xx. Xxxxxx serves as a member of a Data and Safety Monitoring Board for next-generation human papillo- mavirus (HPV) vaccines for Merck and Company.

  • In addition to standard safety monitoring, an independent, external Data and Safety Monitoring Board (DSMB) will oversee the safety of the patients and monitor the occurrence of flare throughout the study.

  • Immunogenicity will also be assessed at weeks 4, 12, 20, 28, 36, 44, and 52 by detection of any presence of anti–IPP-201101 Ab. In addition to standard safety monitoring, an independent, external Data and Safety Monitoring Board (DSMB) will oversee the safety of the patients and monitor the occurrence of flare throughout the study.

  • 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.

  • BLS may terminate this Agreement in its entirety or on a Product-by-Product or country-by-country basis at any time during the Term immediately upon providing written notice to ACADIA if the Data and Safety Monitoring Board or any Regulatory Authority in the United States or Canada imposes a clinical hold on any clinical trial for a Product for six (6) consecutive months.

  • To ensure that appropriate ethical consideration is given to the welfare of the patients enrolled in the study, NINDS-NIH has appointed a Data and Safety Monitoring Board (DSMB) to oversee the trial.

  • We reached the first pre-specified interim analysis at a death event of 159 patients and the Data and Safety Monitoring Board, or DSMB, recommended the trial to continue.

  • 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.


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 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. (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. 24 Apr 2018 CTA Template Version 9.0 DMID CTA Template for DMID-Held IND 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 Committee” (DSMB or DSMC) is an independent group of experts that advises NHLBI and the Investigators. The primary responsibilities of the DSMB are to:
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Related to Data and Safety Monitoring Board

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