: Public Class
Created: 7/27/2010 5:05:33 PM
Modified: 5/28/2019 10:18:24 AM
DEFINITION:<br/>A key document that, together with the study protocol and Statistical Analysis Plan (SAP), prospectively defines the study's Data Monitoring Committee (DMC) infrastructure and, in particular, the DMC's responsibilities; stipulates who sees blinded results and who sees unblinded results; and establishes a method for communication between the DMC and the sponsor.<br/><br/>EXAMPLE(S):<br/><br/>OTHER NAME(S):<br/><br/>NOTE(S):<br/>
Public ST
Map:Statistics v1.0=DataMonitoringCommitteeCharter.description
Notes: DEFINITION:<br/>A textual explanation of the contents of the data monitoring committee charter.<br/><br/>EXAMPLE(S):<br/>"Data will be presented via blinded summaries and listings in PDF format, with additional availability of unblinded patient profiles in electronic format.  The following is a description of the data to be included in the summaries and listingsĀ¦<br/><br/>If the charter is about meeting schedules, then the description could be <br/>"Meetings will be held monthly, beginning 6 weeks after the first subject's first visit."<br/><br/>OTHER NAME(S):<br/><br/>NOTE(S):<br/>
Element Source Role Target Role
Name: influencingDataMonitoringCommitteeCharterVersion
Name: influencedStatisticalAnalysisPlanVersion
DESCRIPTION:<br/>Each DataMonitoringCommitteeCharterVersion might influence one or more StatisticalAnalysisPlanVersion. Each StatisticalAnalysisPlanVersion might be influenced by one or more DataMonitoringCommitteeCharterVersion.<br/><br/>DEFINITION:<br/><br/>EXAMPLE(S):<br/><br/>OTHER NAME(S):<br/><br/>NOTE(S):<br/><br/>
Name: governingDataMonitoringCommitteeCharterVersion
Name: governedOversightCommittee
DESCRIPTION:<br/>Each DataMonitoringCommitteeCharterVersion always governs one OversightCommittee. Each OversightCommittee might be governed by one or more DataMonitoringCommitteeCharterVersion.<br/><br/>DEFINITION:<br/><br/>EXAMPLE(S):<br/><br/>OTHER NAME(S):<br/><br/>NOTE(S):<br/><br/>
Tag Value
Map:Statistics v1.0 DataMonitoringCommitteeCharter
Object Type Connection Direction Notes
DocumentVersion Class Generalization To DESCRIPTION: Each DataMonitoringCommitteeCharterVersion always specializes one DocumentVersion. Each DocumentVersion might be specialized by one DataMonitoringCommitteeCharterVersion. DEFINITION: EXAMPLE(S): OTHER NAME(S): NOTE(S):