Data Monitoring Committee Sample Clauses

Data Monitoring Committee. Not applicable.
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Data Monitoring Committee. An independent Data Monitoring Committee (DMC) will be implemented to detect possible xxxxx and to assure continuous risk/benefit assessment. A DMC is a group of independent experts external to the study assessing the progress, safety data and, if needed, critical efficacy endpoints. Details of the definition of DMC, its composition and its roles and responsibilities can be found in the separate DMC charter.
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Data Monitoring Committee. A DMC will be appointed to review the study data and make recommendations concerning the continuation, modification, or termination of the study. The DMC will perform the following: • Scheduled evaluation of study conduct and progress and review of the cumulative safety and efficacy data. Scheduled meetings will take place as follows: - Kick off meeting before the first participant is enrolled - A meeting at the end of the first influenza season to review safety and efficacy data and perform a futility analysis (with re-powering if required), see Section 7.7.1 • Perform unscheduled review of data if one of the study pausing or holding rules is met, see Section 2.3 There will be a minimum of three appropriately qualified committee members of whom one will be the designated chair. The DMC will operate in accordance with the study-specific charter, which will be agreed prior to the start of enrolment. The chair of the DMC may be contacted for advice and independent review by the Investigator or Sponsor in any other situation where the Investigator or Sponsor feels independent advice or review is important. The DMC will be convened if any of the pausing or holding rules is met. The DMC will be notified within 24 hours of the Investigators’ being aware of any study treatment-related SAEs. The DMC has the power to place the study on hold if deemed necessary. If, following review of data by the DMC, a recommendation to resume study enrolment and vaccine administration is made, the DMC will record their judgment in a memorandum to the study file and notify the Sponsor. The DMC memorandum will be forwarded to the local Medical Monitor and Principal Investigators.
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Data Monitoring Committee. (a) Unless otherwise agreed by the CSOG, clinical trials related to Clinical Studies will be overseen and the results reviewed by an independent Data Monitoring Committee (“DMC”) established and supported by Sponsor. The CSOG will review and approve the DMC’s membership and procedures. Sponsor will assume responsibility for setting up and supporting all DMC meetings. The CSOG will be notified of any DMC meetings. A representative from each party will be invited to attend all open sessions of the DMC meetings. All DMC open sessions reports related to a Clinical Study will be made available to the CSOG.
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Data Monitoring Committee. The Parties may establish a data monitoring committee, of independent clinician(s) agreed to by the Parties, to make safety recommendations about the safety of the Study to the JDC.
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Data Monitoring Committee. (a) Unless otherwise agreed by the COG, clinical trials related to Collaboration Projects will be overseen and the results reviewed by an independent Data Monitoring Committee (“DMC”) established and supported by Juno. The COG will review and approve the DMC’s membership and procedures. Juno will assume responsibility for setting up and supporting all DMC meetings. The COG will be notified of any DMC meetings. A representative from each party will be invited to attend all open sessions of the DMC meetings. All DMC open sessions reports related to a Collaboration Project will be made available to the COG.
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Data Monitoring Committee. Within [***] ([***]) working days after the Restated Effective Date, ARIAD and MERCK will send a letter jointly notifying the members of the SUCCEED Data Monitoring Committee of the change in IND ownership for Ridaforalimus and in the sponsorship of the SUCCEED Trial. MERCK shall thereafter submit the amended Charter of the Data Monitoring Committee for the SUCCEED Trial in the form agreed upon by the Parties contemporaneously with the execution hereof to the members of the Data Monitoring Committee, and upon their approval, submit the same to the FDA. Such amended Charter shall (i) designate MERCK as the trial sponsor, and (ii) replace ARIAD representatives to the Data Monitoring Committee with MERCK representatives. The Parties agree that no meeting of the Data Monitoring Committee for the SUCCEED Trial shall occur until such amendments of such Data Monitoring Committee’s charter have been completed. MERCK shall use Commercially Reasonable Efforts to provide ARIAD with at least [***] ([***]) days advance notice of any meeting of the Data Monitoring Committee for the SUCCEED Trial, and shall permit a senior representative of ARIAD to participate as an observer at all meetings of the Data Monitoring Committee for the SUCCEED Trial. In addition, MERCK shall (i) provide ARIAD copies of all significant correspondence with the Data Monitoring Committee for the SUCCEED Trial and any other Clinical Trial and each significant Regulatory Filing or other document or correspondence pertaining to any Product and submitted to the FDA or other Regulatory Authority and (ii) promptly provide ARIAD with copies of any significant document or other correspondence received from the Data Monitoring Committee for the SUCCEED Trial and any other Clinical Trial or the FDA pertaining to any Product. MERCK shall have the right to make all decisions with respect to recommendations of any Data Monitoring Committee and any responses to any such document or correspondence, but shall consider all comments of ARIAD in good faith. For purposes of this Section 3.9.4(c) Regulatory Filings, correspondence or documents shall be considered “significant” if such document could reasonably be expected to affect the likelihood or timing of obtaining Regulatory Approval, including Commercialization Regulatory Approval, or affect the label claims contained in Commercialization Regulatory Approval, or relate to the safety, efficacy or potency of the Licensed Product, or relate to regulatory complian...
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Related to Data Monitoring Committee

  • Training Committee The parties to this Agreement may form a Training Committee. The Training Committee will be constituted by equal numbers of Employer nominees and ETU employee representatives and have a charter which clearly states its role and responsibilities. It shall monitor the clauses of this Agreement which relate to training and ensure all employees have equal access to training.

  • Steering Committee The Project Manager shall set up a Steering Committee for the Project, consisting of representatives from the Department, the Contractor, and any other key organisations whom the project will impact on, to be agreed between the parties. The function of the Steering Committee shall be to review the scope and direction of the Project against its aims and objectives, monitor progress and efficiency, and assess, manage and review expected impact and use of the findings from the Project. The Committee shall meet at times and dates agreed by the parties, or in the absence of agreement, specified by the Department. The Contractor’s representatives on the Steering Committee shall report their views on the progress of the Project to the Steering Committee in writing if requested by the Department. The Contractor’s representatives on the Steering Committee shall attend all meetings of the Steering Committee unless otherwise agreed by the Department.

  • Project Steering Committee 1. For a sound implementation and management of the project, a steering committee shall be set up in line with provisions of the programme implementation manual.

  • Advisory Committee The Settling State shall designate an Opioid Settlement Remediation Advisory Committee (the “Advisory Committee”) to provide input and recommendations regarding remediation spending from that Settling State’s Abatement Accounts Fund. A Settling State may elect to use an existing advisory committee or similar entity (created outside of a State-Subdivision Agreement or Allocation Statute); provided, however, the Advisory Committee or similar entity shall meet the following requirements:

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