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.

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.

Data Monitoring Committee means a committee described in an FDA draft guidance document dated November 2001 and entitled “On the Establishment and Operation of Clinical Trial Data Monitoring Committees” that is established for the purpose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.

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.

Data Monitoring Committee or “DMC” means any independent data monitoring committee, as designated by WHO in its sole discretion, that is convened under or pursuant to any WHO sponsored clinical trial, WHO-recommended master protocol for clinical trials and/or any WHO-recommended emergency use protocol under the MEURI (Monitored Emergency Use of Unregistered and Experimental Interventions) framework relating to any Products, whether alone or in combination with other products.