DATA AND SAFETY MONITORING BOARD CHARTER Protocol Title: <Title> Principal Investigator: <Name> Co-Investigator: <All names listed in IRB application> Study Staff: <If any> Protocol Number(s): <IRB Number> Sponsor: <Sponsor Name> Date of Document: ____________________________________________________________________________ PURPOSE The purpose of this charter is to define the responsibilities of this Data and Safety Monitoring Board (DSMB), its membership, and timing of meetings. It will also provide the procedures used to carry out these responsibilities. DSMB RESPONSIBILITIES The DSMB has the following responsibilities: Review and sign this charter signifying understanding of responsibilities Review the research protocol, informed consent documents and plans for data safety and monitoring; Evaluate the progress of the trial, including periodic assessments of data quality and timeliness, participant recruitment, accrual and retention, participant risk versus benefit, performance of the trial site, and other factors that can affect study outcome; Consider factors external to the study when relevant information becomes available, such as scientific or therapeutic developments that may have an impact on the safety of the participants or the ethics of the trial; Make recommendations to the PI continuation, termination, or other modifications of the trial based on the observed beneficial or adverse effects of the treatment under study; If appropriate, conduct interim analysis of efficacy in accordance with stopping criteria are clearly defined in advance of data analysis and have the approval of the DSMB; Ensure the confidentiality of the trial data and the results of monitoring; and, Recommend solutions to address problems with study conduct, enrollment, and sample size and/or data collection. MEMBERSHIP
DATA AND SAFETY MONITORING BOARD CHARTER Protocol Title: <Title> Principal Investigator: <Name> Co-Investigator: <All names listed in IRB application> Study Staff: <If any> Protocol Number(s): <IRB Number> Sponsor: <Sponsor Name> Date of Document: ____________________________________________________________________________ PURPOSE The purpose of this charter is to define the responsibilities of this Data and Safety Monitoring Board (DSMB), its membership, and timing of meetings. It will also provide the procedures used to carry out these responsibilities. DSMB RESPONSIBILITIES The DSMB has the following responsibilities: Review and sign this charter signifying understanding of responsibilities Review the research protocol, informed consent documents and plans for data safety and monitoring; Evaluate the progress of the trial, including periodic assessments of data quality and timeliness, participant recruitment, accrual and retention, participant risk versus benefit, performance of the trial site, and other factors that can affect study outcome; Consider factors external to the study when relevant information becomes available, such as scientific or therapeutic developments that may have an impact on the safety of the participants or the ethics of the trial; Make recommendations to the PI continuation, termination, or other modifications of the trial based on the observed beneficial or adverse effects of the treatment under study; If appropriate, conduct interim analysis of efficacy in accordance with stopping criteria are clearly defined in advance of data analysis and have the approval of the DSMB; Ensure the confidentiality of the trial data and the results of monitoring; and, Recommend solutions to address problems with study conduct, enrollment, and sample size and/or data collection. MEMBERSHIP
Template-DSMBCharter.docx