SPIRIT 2013 Statement: defining standard protocol items for clinical trials

• Main Authors: An-Wen Chan (Author), Jennifer M. Tetzlaff (Author), Douglas G. Altman (Author), Andreas Laupacis (Author), Peter C. Gøtzsche (Author), Karmela Krleža-Jerić (Author), Asbjørn Hrobjartsson (Author), Howard Mann (Author), Kay Dickersin (Author), Jesse A. Berlin (Author), Caroline J. Dore (Author), Wendy R. Parulekar (Author), William S.M. Summerskill (Author), Trish Groves (Author), Kenneth F. Schulz (Author), Harold C. Sox (Author), Frank W. Rockhold (Author), Drummond Rennie (Author), David Moher (Author)
• Format: Book
• Published: Pan American Health Organization.
• Subjects: article
• Online Access: Connect to this object online.

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...