: Public Class
Created: 7/27/2010 5:05:33 PM
Modified: 8/7/2012 1:59:20 PM
Project:
Advanced:
DEFINITION:<br /></p><p>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 /></p><p><br /></p><p>EXAMPLE(S):<br /></p><p><br /></p><p>OTHER NAME(S):<br /></p><p><br /></p><p>NOTE(S):<br /></p>
Attribute
Public ST
  description
Details:
Map:Statistics v1.0=DataMonitoringCommitteeCharter.description
Notes: DEFINITION:#lt;br /#gt;#lt;/p#gt;#lt;p#gt;A textual explanation of the contents of the data monitoring committee charter.#lt;br /#gt;#lt;/p#gt;#lt;p#gt;#lt;br /#gt;#lt;/p#gt;#lt;p#gt;EXAMPLE(S):#lt;br /#gt;#lt;/p#gt;#lt;p#gt;"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 listings¦#lt;br /#gt;#lt;/p#gt;#lt;p#gt;#lt;br /#gt;#lt;/p#gt;#lt;p#gt;If the charter is about meeting schedules, then the description could be #lt;br /#gt;#lt;/p#gt;#lt;p#gt;"Meetings will be held monthly, beginning 6 weeks after the first subject's first visit."#lt;br /#gt;#lt;/p#gt;#lt;p#gt;#lt;br /#gt;#lt;/p#gt;#lt;p#gt;OTHER NAME(S):#lt;br /#gt;#lt;/p#gt;#lt;p#gt;#lt;br /#gt;#lt;/p#gt;#lt;p#gt;NOTE(S):#lt;br /#gt;#lt;/p#gt;
Element Source Role Target Role
OversightCommittee
Class   		Name: governingDataMonitoringCommitteeCharterVersion
  		Name: governedOversightCommittee
 
Details:
DESCRIPTION:<br /></p><p>Each DataMonitoringCommitteeCharterVersion always governs one OversightCommittee. Each OversightCommittee might be governed by one or more DataMonitoringCommitteeCharterVersion.<br /></p><p><br /></p><p>DEFINITION:<br /></p><p><br /></p><p>EXAMPLE(S):<br /></p><p><br /></p><p>OTHER NAME(S):<br /></p><p><br /></p><p>NOTE(S):<br /></p>
StatisticalAnalysisPlanVersion
Class   		Name: influencingDataMonitoringCommitteeCharterVersion
  		Name: influencedStatisticalAnalysisPlanVersion
 
Details:
DESCRIPTION:<br /></p><p>Each DataMonitoringCommitteeCharterVersion might influence one or more StatisticalAnalysisPlanVersion. Each StatisticalAnalysisPlanVersion might be influenced by one or more DataMonitoringCommitteeCharterVersion.<br /></p><p><br /></p><p>DEFINITION:<br /></p><p><br /></p><p>EXAMPLE(S):<br /></p><p><br /></p><p>OTHER NAME(S):<br /></p><p><br /></p><p>NOTE(S):<br /></p>
Tag Value
Map:Statistics v1.0 DataMonitoringCommitteeCharter
Details:
 
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):