Effective Management of the Independent Imaging Review Process

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The independent review of imaging and clinical data in oncology clinical trials is becoming increasingly important in supporting trial outcomes. The key to designing a successful independent review process centers on prospectively defining the methodology for the review.

Early in the development of an independent review process, several key documents are generated and signed off as agreements between a sponsor and imaging core lab. These documents include a project plan, Independent Review Charter, and the Investigator Site Manual.

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Author(s): 
Stephen Bates , Kelie Williams
Journal: 
Applied Clinical Trials, May 2, 2007
Copyright: 
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