Tag Archives: case report form

Statistical Reviews of Case Report Forms

Posted on 28 April 2011 by Ask-Cato.com Contributor

A statistical review of a trial case report form (CRF) is highly important for various reasons. The project statistician is aware of the planned primary and secondary endpoint analyses and knows what data will be needed to implement these analyses. … Continue reading →

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When Should You Write your Statistical Analysis Plans?

Posted on 24 May 2010 by Ask-Cato.com Contributor

Recently in the LinkedIn Biostatistics group, one user asked: A client wants me to prepare final SAP [statistical analysis plan] shortly after protocol and CRFs are finalized for a Phase 3 trial, to submit to FDA prior to start of … Continue reading →

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