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SPIRIT 2013 Statement: defining standard protocol items for clinical trials

by jmiller on May 30, 2013

“The protocol of a clinical trial serves as the foundation for study planning, conduct, reporting, and appraisal.  However, trial protocols and existing protocol guidelines vary greatly in content and quality.  This article describes the systematic development and scope of SPIRIT (Standard Protocol Items:  Recommendations for Interventional Trials) 2013, a guideline for the minimum content of a c linical trial protocol.  The 33 item SPIRIT checklis applies to protocols for all clinical trials and focuses on content rather than format.”  (Ann Intern Med, Feb 5)  Click here to read full text.

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