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

  • 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.

  • 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.

  • Lender has agreed to close the transaction contemplated hereby without delivery of said original stock certificates provided that Borrower delivers all of the original stock certificates of M-TRON INDUSTRIES, LTD., a company organized under the laws of Hong Kong, and PIEZO TECHNOLOGY INDIA PRIVATE LTD., a company organized under the laws of India, to Lender on or before the date 60 days from the date of this Agreement.

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

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

  • 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.

  • The DCC supports the Data and Safety Monitoring Board and manages reporting to regulatory authorities (e.g., central IRB, FDA).


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 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. (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;

  • health and safety specification means a site, activity or project specific document prepared by the client pertaining to all health and safety requirements related to construction work;

  • New Jersey Stormwater Best Management Practices (BMP) Manual or “BMP Manual” means the manual maintained by the Department providing, in part, design specifications, removal rates, calculation methods, and soil testing procedures approved by the Department as being capable of contributing to the achievement of the stormwater management standards specified in this chapter. The BMP Manual is periodically amended by the Department as necessary to provide design specifications on additional best management practices and new information on already included practices reflecting the best available current information regarding the particular practice and the Department’s determination as to the ability of that best management practice to contribute to compliance with the standards contained in this chapter. Alternative stormwater management measures, removal rates, or calculation methods may be utilized, subject to any limitations specified in this chapter, provided the design engineer demonstrates to the municipality, in accordance with Section IV.F. of this ordinance and N.J.A.C. 7:8-5.2(g), that the proposed measure and its design will contribute to achievement of the design and performance standards established by this chapter.

  • Quality Management Plan means the portion of the Project Development Plan providing the information requested in Section 4.3 of Exhibit B to the ITP.

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

  • National Ambient Air Quality Standards or “NAAQS” means national ambient air quality standards that are promulgated pursuant to Section 109 of the Act, 42 U.S.C. § 7409.

  • Spatial Planning and Land Use Management Act means the Spatial Planning and Land Use Management Act, 2013 (Act 16 of 2013);

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  • Environmental, Health, and Safety Requirements means all federal, state, local and foreign statutes, regulations, and ordinances concerning public health and safety, worker health and safety, and pollution or protection of the environment, including without limitation all those relating to the presence, use, production, generation, handling, transportation, treatment, storage, disposal, distribution, labeling, testing, processing, discharge, release, threatened release, control, or cleanup of any hazardous materials, substances or wastes, as such requirements are enacted and in effect on or prior to the Closing Date.

  • Health and Safety means matters relating to:

  • Quality management means coordinated activities to direct and control an organization with regard to quality;

  • Department of Health and Human Services means the Department of Health and Human Services

  • High-quality waters means all state waters, except:

  • Workplace safety means those conditions related to physical health and safety of employees enforceable under federal or state law, or District rule related to: safety of the physical work environment, the safe operation of workplace equipment and tools, provision of protective equipment, training and warning requirements, workplace violence and accident risk.

  • General air quality operating permit or "general permit" means an air quality operating permit that meets the requirements of ARM 17.8.1222, covers multiple sources in a source category, and is issued in lieu of individual permits being issued to each source.

  • Cathodic protection tester means a person who can demonstrate an understanding of the principles and measurements of all common types of cathodic protection systems as applied to buried or submerged metal piping and tank systems. At a minimum, such persons must have education and experience in soil resistivity, stray current, structure-to-soil potential, and component electrical isolation measurements of buried metal piping and tank systems.

  • Environmental, Health and Safety Laws means the Comprehensive Environmental Response, Compensation and Liability Act of 1980, the Resource Conservation and Recovery Act of 1976, and the Occupational Safety and Health Act of 1970, each as amended, together with all other laws (including rules, regulations, codes, plans, injunctions, judgments, orders, decrees, rulings, and charges thereunder) of federal, state, local, and foreign governments (and all agencies thereof) concerning pollution or protection of the environment, public health and safety, or employee health and safety, including laws relating to emissions, discharges, releases, or threatened releases of pollutants, contaminants, or chemical, industrial, hazardous, or toxic materials or wastes into ambient air, surface water, ground water, or lands or otherwise relating to the manufacture, processing, distribution, use, treatment, storage, disposal, transport, or handling of pollutants, contaminants, or chemical, industrial, hazardous, or toxic materials or wastes.

  • Waste Framework Directive or “WFD” means Waste Framework Directive 2008/98/EC of the European Parliament and of the Council on waste

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  • Prescription monitoring program or "PMP" means the Wash- ington state prescription monitoring program authorized under chapter

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  • Environmental, Health and Safety Liabilities means any cost, damages, expense, liability, obligation or other responsibility arising from or under any Environmental Law.