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 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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Examples of Data and Safety Monitoring Board in a sentence

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

  • Brii Bio may terminate this Agreement at any time during the Term immediately upon providing written notice to VBI if a Data and Safety Monitoring Board or any Regulatory Authority in the Licensed Territory imposes a clinical hold on any Clinical Trial for a Licensed Product for six (6) consecutive months.

  • If such dispute is not resolved within [**] days following the initiation of such good faith discussions, either Party may elect to have the dispute submitted to a Data and Safety Monitoring Board for resolution and neither Party shall take action with respect to the disputed matter until such dispute is resolved by such Data and Safety Monitoring Board.

  • The Data and Safety Monitoring Board and Plan shall be established and approved prior to beginning the conduct of the clinical trial.

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

  • The Parties shall establish the Data and Safety Monitoring Board promptly after the first such dispute arises.

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

  • Please refer to: NIAID Principles for Use of a Data and Safety Monitoring Board (DSMB) For Oversight of Clinical Trials Policy When a monitor or monitoring board is organized, a description of it, its charter or operating procedures (including a proposed meeting schedule and plan for review of adverse events), and roster and curriculum vitae from all members must be submitted to and approved by the COR before enrollment starts.

  • 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.

  • The Parties (including the appropriate clinical and non-clinical personnel of each Party) shall regularly meet in person or hold a telephone conference to share and discuss the progress of ongoing Ionis Development Activities as well as any available new data and results from ongoing or completed Ionis Development Activities, including but not limited to minutes of the Data and Safety Monitoring Board and/or any other relevant safety documentation.


More Definitions of Data and Safety Monitoring Board

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 means an independent board that is appointed in accordance with rule 12;
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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 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. (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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Related to Data and Safety Monitoring Board

  • Quality Assurance Program means the overall quality program and associated activities including the Department’s Quality Assurance, Design-Builder Quality Control, the Contract’s quality requirements for design and construction to assure compliance with Department Specifications and procedures.

  • health and safety file means a file, or other record containing the information in writing required by these Regulations "health and safety plan" means a site, activity or project specific documented plan in accordance with the client's health and safety specification;

  • Safety Management System means a systematic approach to managing safety, including the necessary organisational structures, accountabilities, policies and procedures;

  • Health and Safety Plan means a documented plan which addresses hazards identified and includes safe work procedures to mitigate, reduce or control the hazards identified;

  • Quality Management System means a set of interrelated or interacting elements that organisations use to direct and control how quality policies are implemented and quality objectives are achieved;