Data Safety Monitoring Board definition

Data Safety Monitoring Board means the group of individuals appointed to monitor safety issues relating to the Study.
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Data Safety Monitoring Board means an independent group of experts who monitor patient safety and treatment efficacy data while a clinical trial is ongoing.
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Data Safety Monitoring Board or “DSMB” is a group of individuals with pertinent expertise that reviews on a regular basis accumulating data from one or more ongoing clinical trials. The DSMB advises the sponsor regarding the continuing safety of Human Subjects and those yet to be recruited to a clinical trial, as well as the continuing validity and scientific merit of the trial. The DSMB is appointed by the Sponsor.
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Examples of Data Safety Monitoring Board in a sentence

  • All trials initiated by the Brown University Oncology Research Group (BrUOG) are subject to oversight by the Data Safety Monitoring Board (DSMB).

  • A Data Safety Monitoring Board (DSMB) will monitor the progress of the PGP, including the risks to study participants.

  • Phase III clinical trials generally require the establishment of a Data Safety Monitoring Board (DSMB).

  • A Data Safety Monitoring Board with prespecified study stopping rules must be stipulated by study protocols.

  • A Data Safety Monitoring Board (DSMB) is established, with responsibility to monitor all aspects of the study.

  • Specify the role of the coordinating centre(s) and different committees (e.g. Data Safety Monitoring Board, Independent Data Monitoring Committee, etc.).

  • The trial will be monitored closely for occurrence of adverse events by the study team and by the Mayo Clinic Cancer Center Data Safety Monitoring Board (DSMB).

  • A Data Safety Monitoring Board consisting of 4 experts (including 3 physicians) knowledgeable in neglected tropical diseases will be in place to monitor the safety data per country and across countries participating in the DOLF project.

  • For medical intervention studies involving more than minimal risk, safety oversight may require the creation of a Data Safety Monitoring Board or Committee with a charter that outlines their objective, or charter, the data they will review and the frequency of that review.

  • In order to meet the requirement set forth by Food and Drug Administration, One bio statistician and one oncology expert, both of whom do not participate in the present study, must be chosen to form and run the Data Safety Monitoring Board (DSMB)‌- At the critical time period such as the start and end of the research, DSMB will inspect the overall progress of the study and research data management, and conduct interim analysis.

Related to Data Safety Monitoring Board

  • Prescription monitoring program “PMP,” or “program” means the program established pursuant to 657—Chapter 37 for the collection and maintenance of PMP information and for the provision of PMP information to authorized individuals.

  • 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.

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

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

  • 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.

  • Database Management System (DBMS) A system of manual procedures and computer programs used to create, store and update the data required to provide Selective Routing and/or Automatic Location Identification for 911 systems. Day: A calendar day unless otherwise specified. Dedicated Transport: UNE transmission path between one of CenturyLink’s Wire Centers or switches and another of CenturyLink’s Wire Centers or switches within the same LATA and State that are dedicated to a particular customer or carrier. Default: A Party’s violation of any material term or condition of the Agreement, or refusal or failure in any material respect to properly perform its obligations under this Agreement, including the failure to make any undisputed payment when due. A Party shall also be deemed in Default upon such Party’s insolvency or the initiation of bankruptcy or receivership proceedings by or against the Party or the failure to obtain or maintain any certification(s) or authorization(s) from the Commission which are necessary or appropriate for a Party to exchange traffic or order any service, facility or arrangement under this Agreement, or notice from the Party that it has ceased doing business in this State or receipt of publicly available information that signifies the Party is no longer doing business in this State.

  • Project Management Plan means the portion of the Project Development Plan providing the information requested in Section 4.2 of Exhibit B to the ITP.

  • Monitoring Committee means the committee established under clause 10 of this Award.

  • 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 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;

  • Radiation safety officer means an individual who has the knowledge and responsibility to apply appropriate radiation protection regulations and has been assigned such responsibility by the licensee or registrant.

  • Database Management System (“DBMS”) is a computer process used to store, sort, manipulate and update the data required to provide Selective Routing and ALI.

  • Service Management System (SMS) means an off-line system used to access, create, modify, or update information in a Database.

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

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

  • Architectural Review Committee or “ARC” shall mean the architectural review committee established by the Organization to review plans submitted to the Organization for architectural review.

  • Project Management Report means each report prepared in accordance with Section 4.02 of this Agreement;

  • Procurement Policy Board or “PPB” shall mean the board established pursuant to Charter § 311 whose function is to establish comprehensive and consistent procurement policies and rules which have broad application throughout the City.

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

  • Technical Committee means the body established in accordance with article VII;

  • 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.

  • Drug therapy management means the review of a drug therapy regimen of a patient by one or more pharmacists for the purpose of evaluating and rendering advice to one or more practitioners regarding adjustment of the regimen.

  • Medication administration means the direct application of a medication or device by ingestion, inhalation, injection or any other means, whether self-administered by a resident, or administered by a guardian (for a minor), or an authorized health care provider.

  • Medical Review Officer (MRO means a licensed physician, employed with or contracted with the City, responsible for receiving laboratory results generated by the City's drug testing program who has knowledge of substance abuse disorders, laboratory testing procedures, and chain of custody collection procedures; who verifies positive, confirmed test results, and who has the necessary and appropriate medical training to interpret and evaluate an individual's confirmed positive test result together with his or her medical history and any other relevant biomedical information.

  • 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;

  • Change Management means the add-on module to the Programs that enables engineers to define network changes through one or more configuration templates. Those network changes can be applied to multiple devices and executed/rolled back automatically. The Change Management module enables engineers to verify the impact of the changes across the network to help ensure a safer change process.