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People also ask
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What does a monitoring plan include?
A data monitoring plan must have provisions to monitor individual data points collected for data analysis, as well as required study documentation, such as IRB and sponsor documentation, consent documents, adverse event reports, etc.
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How much do DSMB members get paid?
DSMB members are usually compensated for their time for review of the study materials and participation in the meetings at up to $1,000 per year depending upon the type and complexity of the study.
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What is the purpose of a DSMB?
A DSMB monitors the safety of study participants and the effectiveness of the study investigational therapy during a clinical trial. Members of the disease community are often a member of a DSMB for a clinical trial for their disorder.
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What is the DSMP guideline?
A Data and Safety Monitoring Plan (DSMP) is required for all research, regardless of the risk level. Investigators must have adequate plans in place to protect human subjects throughout data collection and analysis. Investigators should maintain a data safety monitoring plan and update policies throughout the research.
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Do DSMB members get paid?
DSMB members will receive per diem and travel expenses in ance with Standard Government Travel Regulations. Members who are officers or employees of the United States shall not receive compensation for service on the DSMB.
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What is the difference between a DMC and a DSMB?
What is the difference between a DMC and a DSMB? The terms DMC and DSMB are essentially synonymous and used interchangeably. The US FDA and EU EMA guidelines both use the DMC's terminology; however, in practice, these committees are typically called DSMB or independent safety monitoring boards (ISMB).
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What is a data and safety monitoring plan?
A DSMP prospectively identifies and documents monitoring activities intended to protect the safety of the subjects, the validity of the data, and the integrity of the research study.
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