Common use of Independent Data Monitoring Committee Clause in Contracts

Independent Data Monitoring Committee. (IDMC) - a group of individuals with pertinent expertise that reviews on a regular basis accumulating data from an ongoing clinical trial. The IDMC advises the sponsor regarding the continuing safety of current participants and those yet to be recruited, as well as the continuing validity and scientific merit of the trial. The Contractor may be required to use relevant members from an established BARDA IDMC or to organize an independent IDMC. The Contractor will submit the composition of the IDMC to the Contracting Officer’s Representative for review. All phase III clinical trials must be reviewed by IDMC; other trials may require IDMC oversight as well. Please refer to FDA Guidance for Clinical Trials Sponsors “Establishment and Operation of Clinical Trial Data Monitoring Committees”. The Government retains the right to place a nonvoting member on the IDMC. When a safety monitoring entity is organized, a description of it, its charter or operating procedures (including a proposed meeting schedule and plan for review of adverse events), and roster and curriculum vitae from all members must be submitted to the Government before Visterra, Inc. HHSO100201500018C enrollment starts. Additionally, the Contractor must submit written summaries of all reviews conducted by the monitoring group to the Government within 30 days of reviews or meetings.