A Trial Management Team Sample Clauses

A Trial Management Team. (TMT) The TMT chaired by the trial coordinating investigator, will be established for the day-to-day management of the Clinical Trial, i.e., operational committee to include trial principal investigators, CHUB-Euclid (trial Project manager, safety officer, data manager, methodologist and statistician), national key staff (trial Project managers and/or clinical research associates). The TMT will monitor the Clinical Trial progress according to qualitative and quantitative performance indictors to be developed by CHUB-Euclid in the TMT charter (e.g. regulatory submission, participant inclusion, on-site monitoring visits, key data entry, lost-to-follow-up participants, logistic circuits, on-site safety reporting). The TMT will conduct monthly teleconferences to discuss Clinical Trial progress, which will be presented afterwards in a TMT report. Ethics Advisory Board (EAB) An Ethics Advisory Board (EAB) will be appointed by the Steering Committee. The EAB will observe and deal with issues relevant to ethics. Functioning as an academic and patient-driven advisory group, it will evaluate and guide BEAT AF Consortium on all ethics, patient safety and scientific conduct issues. The EAB will safeguard the Project's compliance with all necessary ethical regulations by checking the ethical aspects of the study protocols and standards implemented for patient recruitment and prospective examinations. All Parties agree to give a proxy to the Coordinator to ensure that the non-disclosure agreement in Attachment 5 shall be executed between the Coordinator and each EAB member. Its terms shall be not less stringent than those stipulated in this Consortium Agreement, and it shall be concluded no later than 30 (thirty) calendar days after their nomination or before any Confidential Information will be exchanged, whichever date is earlier. The Coordinator shall write the minutes of the EAB meetings and prepare the implementation of the EAB's suggestions. The EAB members shall be allowed to participate in Steering Committee meetings upon invitation but have not any voting rights.
Sample 1
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