Data and Safety Monitoring Requirements Sample Clauses

The Data and Safety Monitoring Requirements clause establishes the obligation to monitor and oversee the collection, management, and protection of data, as well as the safety of participants in a research or clinical study. Typically, this involves setting up a data and safety monitoring board or committee, regular review of study data, and prompt reporting of adverse events or safety concerns. The core function of this clause is to ensure participant safety and data integrity throughout the study, thereby minimizing risks and ensuring compliance with regulatory and ethical standards.
Data and Safety Monitoring Requirements. The Contractor may be required to conduct independent safety monitoring for clinical trials of investigational drugs, devices, or biologics; clinical trials of licensed products; and clinical research of any type involving more than minimal risk to volunteers. Independent monitoring can take a variety of forms. Phase III clinical trials must have an assigned independent data and safety monitoring board (DSMB); other trials may require DSMB oversight as well. The Contractor shall inform the Government of any upcoming site visits and/or audits of Contractor facilities funded under this effort. BARDA reserves the right to accompany the Contractor on site visits and/or audits of Contractors and Subcontractors as the Government deems necessary. The type of monitoring to be used shall be mutually agreed upon between the Contractor and the Government before enrollment starts. Discussions with the responsible BARDA COR regarding appropriate safety monitoring and approval of the final monitoring plan by BARDA must occur before patient enrollment begins and may include discussions about the appointment of one of the following:
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Data and Safety Monitoring Requirements. BARDA strongly recommends independent safety monitoring for clinical trials of investigational drugs, devices, or biologics; clinical trial of licensed products; and clinical research of any type involving more than minimal risk to volunteers. Independent monitoring can take a variety of forms. Phase III clinical trials must be reviewed by an independent data and safety monitoring board (DSMB); other trials may require DSMB oversight as well. The Contractor shall inform BARDA of any upcoming site visits and/or audits of CRO facilities funded under this effort. BARDA reserves the right to accompany the Contractor on site visits and/or audits of CROs as BARDA deems necessary. The Contractor shall inform BARDA 30 days in advance of a DSMB board meetings for studies funded under this effort. ▇▇▇▇▇ reserves the right to participate in the DSMB board meetings on an impromptu basis as a non-voting member, if feasible per the structure of the study. If not, the communications from the DSMB to the Contractor should be made available to BARDA upon receipt. A risk is minimal where the probability and magnitude of harm or discomfort anticipated in the proposed research are not greater than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests. For examples, the risk of drawing a small amount of blood from a healthy individual for research purposes is no greater than the risk of doing so as part of a routine physical examination (45 C.F.R. § 46.102(j)). Final decisions regarding the type of monitoring to be used must be made by the Contractor, based on FDA and BARDA guidance, before enrollment starts. Discussions with the responsible BARDA PO/CORregarding appropriate safety monitoring must take place, and the Contractor must submit a written response to all concerns raised by ▇▇▇▇▇, before patient enrollment begins and may include discussions about the appointment of one of the following: When a monitor or monitoring board 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 BARDA before enrollment starts. If concerns are raised, Contractor must address all concerns to BARDA, in writing, before enrollment begins. The Contractor will also ensure that the monitors and board members report any conflicts of interest and the Contractor w...
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Data and Safety Monitoring Requirements. The Contractor may be required to conduct independent safety monitoring for clinical trials of investigational drugs, devices, or biologics; clinical trials of licensed products; and clinical research of any type involving more than minimal risk to volunteers. Independent monitoring can take a variety of forms. Phase III clinical trials must have an assigned independent data and safety monitoring board (DSMB); other trials may require DSMB oversight as well. The Contractor shall inform the Government of any upcoming site visits and/or audits of Contractor or Subcontractor facilities funded under this effort. BARDA reserves the right to accompany the Contractor on site visits and/or audits of Contractor or Subcontractor facilities funded under this contract, as the Government deems necessary. The type of monitoring to be used in a particular clinical trial shall be mutually agreed upon between the Contractor and the Government during the process of finalizing study protocol. Discussions with the responsible BARDA COR regarding appropriate safety monitoring and approval of the final monitoring plan by BARDA must occur before clinical trial begins and may include, but not limited to the discussions about the appointment of one of the following:
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Data and Safety Monitoring Requirements. BARDA strongly recommends independent safety monitoring for clinical trials of investigational drugs, devices, or biologics; clinical trial of licensed products; and clinical research of any type involving more than minimal risk to volunteers. Independent monitoring can take a variety of forms. Phase III clinical trials must be reviewed by an independent data and safety monitoring board (DSMB); other trials may require DSMB oversight as well. The Contractor shall inform BARDA of any upcoming site visits and/or audits of CRO facilities funded under this effort. BARDA reserves the right to accompany the Contractor on site visits and/or audits of CROs as BARDA deems necessary. A risk is minimal where the probability and magnitude of harm or discomfort anticipated in the proposed research and not greater than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests. For examples, the risk of drawing a small amount of blood from a healthy individual for research purposes is no greater than the risk of doing so as part of a routine physical examination (45 CFR 46.102I). Final decisions regarding the type of monitoring to be used must be made jointly by BARDA and the Contractor before enrollment starts. Discussions with the responsible BARDA Project Officer regarding appropriate safety monitoring and approval of the final monitoring plan by ▇▇▇▇▇ must occur before patient enrollment begins and may include discussions about the appointment of one of the following.
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Data and Safety Monitoring Requirements. The Contractor may be required to conduct independent safety monitoring for clinical trials of investigational drugs, devices, or biologics; clinical trials of licensed products; and clinical research of any type involving more than minimal risk to volunteers. Independent monitoring can take a variety of forms. Phase III clinical trials must have an assigned independent data and safety monitoring board (DSMB); other trials may require DSMB oversight as well. The Contractor shall inform the Government of any upcoming site visits and/or audits of Contractor facilities funded under the CPFF CLINs of this contract. BARDA reserves the right to accompany the Contractor on site visits and/or audits of Contractors and Subcontractors as the Government deems necessary. The type of monitoring to be used shall be mutually agreed upon between the Contractor and the Government before enrollment starts. Discussions with the responsible BARDA COR regarding appropriate safety monitoring and approval of the final monitoring plan by BARDA must occur before patient enrollment begins and may include discussions about the appointment of one of the following: a. Independent Safety Monitor – a physician or other appropriate expert who is independent of the study and available in real time to review and recommend appropriate action regarding adverse events and other safety issues. b. Independent Monitoring Committee (IMC) or Safety Monitoring Committee (SMC) – a small group of independent investigators and biostatisticians who review data from a particular study.
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Data and Safety Monitoring Requirements. BARDA strongly recommends independent safety monitoring for clinical trials of investigational drugs, devices, or biologics; clinical trial of licensed products; and clinical research of any type involving more than minimal risk to volunteers. Independent monitoring can take a variety of forms. Phase III clinical trials must be reviewed by an independent data and safety monitoring board (DSMB); other trials may require DSMB oversight as well. The Contractor shall inform BARDA of any upcoming site visits and/or audits of CRO facilities funded under this effort. BARDA reserves the right to accompany the Contractor on site visits and/or audits of CROs as BARDA deems necessary. A risk is minimal where the probability and magnitude of harm or discomfort anticipated in the proposed research and not greater than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests. For examples, the risk of drawing a small amount of blood from a healthy individual for research purposes is no greater than the risk of doing so as part of a routine physical examination (45 CFR 46.102I). Final decisions regarding the type of monitoring to be used must be made jointly by BARDA and the Contractor before enrollment starts. Discussions with the responsible BARDA Project Officer regarding appropriate safety monitoring and approval of the final monitoring plan by ▇▇▇▇▇ must occur before patient enrollment begins and may include discussions about the appointment of one of the following.  Independent Safety Monitor – a physician or other appropriate expert who is independent of the study and available in real time to review and recommend appropriate action regarding adverse events and other safety issues.  Independent Monitoring Committee (IMC) or Safety Monitoring Committee (SMC) – a small group of independent investigators and biostatisticians who review data from a particular study.  Data and Safety Monitoring Board – an independent committee charged with reviewing safety and trial progress and providing advice with respect to study continuation, modification, and termination. The Contractor may be required to use an established BARDA DSMB or to organize an independent DSMB. All phase III clinical trials must be reviewed by a DSMB; other trials may require DSMB oversight as well. Please refer to: NIAID Principles for Use of a Data and Safety Monitoring Board (DSMB) For Oversight of Clinical Trials Policy. When a...
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Related to Data and Safety Monitoring Requirements

  • Monitoring Requirements This Schedule sets out the contract management requirements which are applicable to the delivery of the Services.

  • Quality Assurance Requirements There are no special Quality Assurance requirements under this Agreement.

  • Staffing Requirements Licensee will be in full compliance with the main studio staff requirements as specified by the FCC.

  • Training Requirements Grantee will: A. Authorize and require staff (including volunteers) to attend training, conferences, and meetings as directed by DSHS. B. Appropriately budget funds to meet training requirements in a timely manner, and ensure staff and volunteers are trained as specified in the training requirements listed at ▇▇▇▇▇://▇▇▇.▇▇▇▇.▇▇▇▇▇.▇▇▇/hivstd/training/ and as otherwise specified by DSHS. Grantee shall document that these training requirements are met. C. Follow the appropriate DSHS POPS by funding opportunity (as per Section I: General Requirements for All Grantees) for training and observation requirements.

  • Interface Requirements 2.4.5.1 The NID shall be equal to or better than all of the requirements for NIDs set forth in the applicable industry standard technical references.