Common use of Data and Safety Monitoring Requirements Clause in Contracts

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. XXXXX 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 XXXXX, 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 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. BARDA should be provided documentation from DSMB and should be provided with any decisions by Contractor regarding the DMSB as it relates to work under this contract. 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 will maintain a record of this. The Contractor will share conflict of interest reports with XXXXX. Additionally, the Contractor must submit written summaries of all reviews conducted by the monitoring group to the BARDA within thirty (30) days of reviews or meetings.

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. XXXXX 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 COR regarding appropriate safety monitoring must take place, and the Contractor must submit a written response to all concerns raised by XXXXX, 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 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. BARDA should be provided documentation from DSMB and should be provided with any decisions by Contractor regarding the DMSB as it relates to work under this contract. 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 will maintain a record of this. The Contractor will share conflict of interest reports with XXXXX. Additionally, the Contractor must submit written summaries of all reviews conducted by the monitoring group to the BARDA within thirty (30) days of reviews or meetings.

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. XXXXX 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 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 C.F.R. § 46.102(j)CFR 46.102I). Final decisions regarding the type of monitoring to be used must be made jointly by BARDA and the Contractor, based on FDA and BARDA guidance, Contractor before enrollment starts. Discussions with the responsible BARDA PO/CORregarding Project Officer regarding appropriate safety monitoring and approval of the final monitoring plan by XXXXX must take place, and the Contractor must submit a written response to all concerns raised by XXXXX, 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. BARDA should be provided documentation from DSMB and should be provided with any decisions by Contractor regarding the DMSB as it relates to work under this contract. 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 and approved by the COR 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 will maintain a record of this. The Contractor will share conflict of interest reports with XXXXXthe CO and COR. Additionally, the Contractor must submit written summaries of all reviews conducted by the monitoring group to the BARDA within thirty (30) days [***] of reviews or meetings.