Common use of Data Monitoring Committee Clause in Contracts

Data Monitoring Committee. An independent Data Monitoring Committee (DMC) will be implemented to detect possible xxxxx and to assure continuous risk/benefit assessment. A DMC is a group of independent experts external to the study assessing the progress, safety data and, if needed, critical efficacy endpoints. Details of the definition of DMC, its composition and its roles and responsibilities can be found in the separate DMC charter.

Appears in 5 contracts

Samples: Study Protocol, Study Protocol, Study Protocol

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Data Monitoring Committee. β€Œ An independent Data Monitoring Committee (DMC) with multidisciplinary representation will be implemented established to detect possible xxxxx evaluate accumulating trial data on a periodic basis and to assure continuous risk/benefit assessmentassess the ongoing safety of the study for the subjects enrolled and to be enrolled. A As a result, following each data review, the DMC is will make a group of independent experts external recommendation to the study assessing sponsor regarding continuation, revision, or termination of the progress, safety data and, if needed, critical efficacy endpointsstudy. Details of the definition of DMCrelated to DMC responsibilities, its composition authorities, and its roles and responsibilities can procedures will be found documented in the separate DMC charter, which will be finalized by the DMC prior to the first DMC data review meeting.

Appears in 1 contract

Samples: Investigator Agreement

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