Data Monitoring Committee definition

Data Monitoring Committee means, with respect to the CVOT PMR Study, the data monitoring committee established and existing under a data monitoring committee charter, which charter may be updated from time to time. […***…] shall have the right to have […***…] representatives present at all open session meetings of the Data Monitoring Committee and shall receive […***…] copy of all open session meeting materials.
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Data Monitoring Committee means a committee described in an FDA draft guidance document dated November 2001 and entitled “On the Establishment and Operation of Clinical Trial Data Monitoring Committees” that is established for the purpose of reviewing data from a clinical study, including safety data.
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Data Monitoring Committee is the Data Monitoring Committee of Borrower, a committee of three (3) industry recognized experts in oncology drug development, independent, and appointed to monitor the HEAT study per charter, which meets periodically to review and report on the safety and efficacy of the HEAT study clinical data.
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Examples of Data Monitoring Committee in a sentence

  • Any data provided to Collaborator(s) for Phase 3 studies must be in accordance with the guidelines and policies of the responsible Data Monitoring Committee (DMC), if there is a DMC for this clinical trial.

  • In particular, strong clumping in the ejecta could reduce the mean optical depth substantially for a given ejecta mass.

  • The assigned QAM, with oversight from the Data Monitoring Committee, will monitor this study in accordance with the study phase and risk level.

  • The TSC will review the recommendations of the Independent Data Monitoring Committee and, on consideration of this information, recommend any appropriate amendments/actions for the trial as necessary.

  • Routine AEs will be reviewed by the Data Monitoring Committee (DMC) according to the study’s phase and risk level, as outlined in the DSMP.

  • The use of interim data and Data Monitoring Committee recommendations in randomized controlled trial reports: frequency, implications and potential sources of bias.

  • An independent Data Monitoring Committee (DMC) will be established to oversee the safety of participants in the trial.

  • It is recommended that an Independent Data Monitoring Committee (IDMC) is appointed in order to review safety data regularly throughout the trial and when necessary, recommend to the Sponsor whether to continue, modify or terminate the trial.

  • Any data provided to Collaborator(s) for phase 3 studies must be in accordance with the guidelines and policies of the responsible Data Monitoring Committee (DMC), if there is a DMC for this clinical trial.

  • The TSC will consider and act, as appropriate, upon the recommendations of the Data Monitoring Committee (DMC).


More Definitions of Data Monitoring Committee

Data Monitoring Committee means the data monitoring committee established by the Company for purposes of the Phase III Trial.
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Related to Data Monitoring Committee

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

  • Technical Advisory Committee means a committee established under section 12;

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

  • Screening Committee means the State level Screening Committee constituted in terms of sub-rule (2) of rule 123 of these rules.

  • Network Operating Committee means a group made up of representatives from the Network Customer(s) and the Transmission Provider established to coordinate operating criteria and other technical considerations required for implementation of Network Integration Transmission Service under Tariff, Part III.

  • Steering Committee has the meaning set forth in Section 2.

  • independent review committee means the independent review committee of the investment fund established under National Instrument 81-107 Independent Review Committee for Investment Funds;

  • Development Committee shall have the meaning set forth in Section 3.4.1.

  • 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 Steering Committee means the committee referred to in Section I.A.1 of Schedule 2 to this Agreement.

  • Operating Committee means the Operating Committee of Epoch which meets frequently and is responsible for implementing the Company’s strategy, making operational decisions and overseeing the day-to-day running of the Company.

  • Advisory Committee means the Employer's Advisory Committee as from time to time constituted.

  • Finance Committee means the Finance Committee of the University;

  • Review Committee or “Committee” means a committee established pursuant to rule Chapter 67-60, F.A.C.

  • Managing Committee means the individual or the body of individuals entrusted or charged with the management and administration of a private educational institution and where a society, trust, or an association manages more than one such institution, includes the managing committee of each such institution;

  • Transition Committee shall have the meaning set forth in Section 2.14.

  • JSC has the meaning set forth in Section 3.1.

  • Joint Steering Committee or “JSC” has the meaning set forth in Section 3.1.

  • Supervisory Committee means the Comisión Fiscalizadora of the Company.

  • Joint Remediation Committee has the meaning set forth in Section II.A.2.