Common use of Data Monitoring Committee Clause in Contracts

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.