SPIRIT 2013 Statement: Defining Standard Protocol Items for Clinical Trials

Chan, An‐Wen; Tetzlaff, Jennifer; G. Altman, Douglas; Laupacis, Andreas; C Gøtzsche, Peter; Krleža-Jerić, Karmela; Hróbjartsson, Asbjørn; Mann, Howard; Dickersin, Kay; A. Berlin, Jesse; J Doré, Caroline; R. Parulekar, Wendy; Summerskill, William; Groves, Trish; F. Schulz, Kenneth; C. Sox, Harold; W. Rockhold, Frank; Rennie, Drummond; Moher, David

doi:10.7326/0003-4819-158-3-201302050-00583

Public

SPIRIT 2013 Statement: Defining Standard Protocol Items for Clinical Trials

Published in Annals of Internal Medicine • Feb 5, 2013

Authors:

An‐Wen Chan

Jennifer Tetzlaff

Douglas G. Altman

Abstract

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 Ite...

Subject

Medicine

Protocol (science)

Statement (logic)

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