Independent Data Monitoring Committee Clause Samples

An Independent Data Monitoring Committee (IDMC) clause establishes a group of experts who are separate from the study sponsors and investigators, tasked with overseeing the safety and efficacy data during a clinical trial. This committee regularly reviews interim data, monitors for adverse events, and can recommend modifications or early termination of the study if significant concerns arise. The core function of this clause is to ensure unbiased oversight and participant safety, thereby maintaining the integrity of the trial and protecting subjects from undue risk.
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.
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Independent Data Monitoring Committee. An Independent Data Monitoring Committee (IDMC) will be established comprising of at least 5 independent experts (2 medical oncologists, two immunotherapists and one statistician) who have no conflict of interest and agree with the outline of the protocol. None of the members of the IDMC should be among the participants in the trial. The committee will meet when the interim analysis has been performed by the statistician of the trial. All possible aspects of the trial will be the subject of the interim analysis (see section 11.3.
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Independent Data Monitoring Committee. An IDMC will not be utilized in this study. Sponsor will monitor safety in accordance with ICH- GCP E6 (R2) guidelines.
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Independent Data Monitoring Committee. “IDMC”). OPKO will establish an IDMC for each Trial if not already established, which will be governed by a charter substantially in the form to be agreed upon by the Parties within *** days of the Effective Date (the “IDMC Charter”). For clarity, the IDMC Charter will specify the number of members of the IDMC, the qualifications of such members, the experience of the chairman of the IDMC, details regarding open and closed sessions, including who can attend any such sessions, and information that the IDMC may share with the Parties, including that efficacy will not be disclosed to either Party until the IDMC has approved such data. OPKO will communicate any decision of the IDMC to the JDC within five (5) Business Days of such decision. OPKO will ensure that the IDMC is provided with all information and data that it requires as specified in the IDMC Charter, and Pfizer will reasonably cooperate with OPKO in such regard. OPKO will ensure that all members of the IDMC have any licenses, certifications and/or accreditations required by Applicable Laws; and understand the Development Plan and their obligation to comply therewith and all Applicable Laws in conducting such Trial(s). Any such representations and warranties will be made for the benefit of OPKO and Pfizer as third party beneficiaries. OPKO will ensure that each member completes the Financial Disclosure Form. For clarity, if any of the foregoing individuals do not complete such Financial Disclosure Form, such individuals may not participate in the IDMC.
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Independent Data Monitoring Committee. An IDMC has been established for this study and specific guidelines on the operation and purpose of the IDMC is documented in a Charter. The committee includes at least 3 members, including a statistician and medical oncologists experienced in the treatment of EOC. Safety review meetings will be held as per the IDMC charter and as needed if any unexpected safety signals emerge during the study. The IDMC will be responsible for independently evaluating safety data of patients enrolled to the study. Decisions on study termination, amendment of the protocol, or cessation of patient recruitment will be made after recommendations from the IDMC have been assessed by the Sponsor.
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Related to Independent Data Monitoring Committee

  • Technical Advisory Committee (TAC The goal of this subtask is to create an advisory committee for this Agreement. The TAC should be composed of diverse professionals. The composition will vary depending on interest, availability, and need. TAC members will serve at the CAM’s discretion. The purpose of the TAC is to: • Provide guidance in project direction. The guidance may include scope and methodologies, timing, and coordination with other projects. The guidance may be based on: o Technical area expertise; o Knowledge of market applications; or o Linkages between the agreement work and other past, present, or future projects (both public and private sectors) that TAC members are aware of in a particular area. • Review products and provide recommendations for needed product adjustments, refinements, or enhancements. • Evaluate the tangible benefits of the project to the state of California, and provide recommendations as needed to enhance the benefits. • Provide recommendations regarding information dissemination, market pathways, or commercialization strategies relevant to the project products. The TAC may be composed of qualified professionals spanning the following types of disciplines: • Researchers knowledgeable about the project subject matter; • Members of trades that will apply the results of the project (e.g., designers, engineers, architects, contractors, and trade representatives); • Public interest market transformation implementers; • Product developers relevant to the project; • U.S. Department of Energy research managers, or experts from other federal or state agencies relevant to the project; • Public interest environmental groups; • Utility representatives; • Air district staff; and • Members of relevant technical society committees. • Prepare a List of Potential TAC Members that includes the names, companies, physical and electronic addresses, and phone numbers of potential members. The list will be discussed at the Kick-off meeting, and a schedule for recruiting members and holding the first TAC meeting will be developed. • Recruit TAC members. Ensure that each individual understands member obligations and the TAC meeting schedule developed in subtask 1.11. • Prepare a List of TAC Members once all TAC members have committed to serving on the TAC. • Submit Documentation of TAC Member Commitment (such as Letters of Acceptance) from each TAC member. • List of Potential TAC Members • List of TAC Members • Documentation of TAC Member Commitment

  • Scheduling Committee This Committee shall be a function of the Hospital-Association Committee and shall examine scheduling/staffing patterns on units brought to its attention and shall review suggested changes to current schedules or staffing on a unit basis. Where the Committee finds significant change(s) to be proposed, it may require a vote of the nurses on the unit to be held.

  • Technical Committee 1. The Technical Committee shall comprise: (a) nine experts representing different regions of the Agreement Area, in accordance with a balanced geographical distribution; (b) one representative from the International Union for Conservation of Nature and Natural Resources (IUCN), one from the International Waterfowl and Wetlands Research Bureau (IWRB) and one from the International Council for Game and Wildlife Conservation (CIC); and (c) one expert from each of the following fields: rural economics, game management, and environmental law. The procedure for the appointment of the experts, the term of their appointment and the procedure for designation of the Chairman of the Technical Committee shall be determined by the Meeting of the Parties. The Chairman may admit a maximum of four observers from specialized international inter- governmental and non-governmental organizations. 2. Unless the Meeting of the Parties decides otherwise, meetings of the Technical Committee shall be convened by the Agreement secretariat in conjunction with each ordinary session of the Meeting of the Parties and at least once between ordinary sessions of the Meeting of the Parties. 3. The Technical Committee shall: (a) provide scientific and technical advice and information to the Meeting of the Parties and, through the Agreement secretariat, to Parties; (b) make recommendations to the Meeting of the Parties concerning the Action Plan, implementation of the Agreement and further research to be carried out; (c) prepare for each ordinary session of the Meeting of the Parties a report on its activities, which shall be submitted to the Agreement secretariat not less than one hundred and twenty days before the session of the Meeting of the Parties, and copies shall be circulated forthwith by the Agreement secretariat to the Parties; and (d) carry out any other tasks referred to it by the Meeting of the Parties. 4. Where in the opinion of the Technical Committee there has arisen an emergency which requires the adoption of immediate measures to avoid deterioration of the conservation status of one or more migratory waterbird species, the Technical Committee may request the Agreement secretariat to convene urgently a meeting of the Parties concerned. These Parties shall meet as soon as possible thereafter to establish rapidly a mechanism to give protection to the species identified as being subject to particularly adverse threat. Where a recommendation has been adopted at such a meeting, the Parties concerned shall inform each other and the Agreement secretariat of measures they have taken to implement it, or of the reasons why the recommendation could not be implemented. 5. The Technical Committee may establish such working groups as may be necessary to deal with specific tasks.

  • Audit Committee (A) The Audit Committee shall be composed of five members who shall be selected by the Board of Directors from its own members, none of whom shall be an officer of the Company, and shall hold office at the pleasure of the Board. (B) The Audit Committee shall have general supervision over the Audit Division in all matters however subject to the approval of the Board of Directors; it shall consider all matters brought to its attention by the officer in charge of the Audit Division, review all reports of examination of the Company made by any governmental agency or such independent auditor employed for that purpose, and make such recommendations to the Board of Directors with respect thereto or with respect to any other matters pertaining to auditing the Company as it shall deem desirable. (C) The Audit Committee shall meet whenever and wherever the majority of its members shall deem it to be proper for the transaction of its business, and a majority of its Committee shall constitute a quorum.

  • Operating Committee the Consortium’s managing body, composed of representatives of the Manager and the Contractors, pursuant to Annex XI.