_Lecture notes_dsmc_clinicaltrials

_Lecture notes_dsmc_clinicaltrials - Data Safety and...

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Data Safety and Monitoring Committee (DSMC) Reasons to have a DSMC: They provide a workable mechanism for coping with the problem of protecting the interest and safety of study participants, while preserving the scientific integrity of the trial. Decisions will be made independently of academic and economic pressures since the committee is usually independent of the study investigators. Many sponsors of trials support or require such a mechanism Basic information about the DSMC: The committee consists of 3-10 members of: clinical, statistical, epidemiological, laboratory, data management and ethical experts. Meet once to twice a year, depending on the study progress A single DSMC may review multiple studies or may monitor all ongoing trials Consists of two sessions, an open and a closed session o Open consists of general progress of the study: Accrual Baseline demographics Data accuracy and protocol compliance Patient safety (Adverse Events)
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_Lecture notes_dsmc_clinicaltrials - Data Safety and...

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