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Data Monitoring Committees DMCs

Data monitoring committee (DMC) utilization. Consider the need for a program-level DMC or whether individual study DMCs will suffice (and which studies need a DMC). [Pg.59]

CHMP (2005) Guidance on Data Monitoring Committees/ FDA (2006) Establishment and Operation of Clinical Trial Data Monitoring Committees These documents provided guidance on the set up, operational and working procedures, and the roles and responsibilities of the DMC in a single clinical trial or collection of trials (see Section 14.4). [Pg.248]

See other pages where Data Monitoring Committees DMCs is mentioned: [Pg.219]    [Pg.181]    [Pg.20]    [Pg.189]    [Pg.257]    [Pg.331]    [Pg.124]    [Pg.219]    [Pg.181]    [Pg.20]    [Pg.189]    [Pg.257]    [Pg.331]    [Pg.124]    [Pg.294]    [Pg.70]    [Pg.85]   
See also in sourсe #XX -- [ Pg.218 , Pg.224 , Pg.248 ]



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