Published in January 2013 in both the BMJ and Annals of Internal Medicine, the SPIRIT (Standard Protocol Items: Recommendations for Interventional Trials) 2013 Statement provides guidance regarding the minimum content that should be included in a clinical trial protocol. A 33-item checklist and diagram are provided with the aim of helping to ensure that published trial protocols are of a high quality.
An explanatory paper (SPIRIT 2013 Explanation and Elaboration: Guidance for Protocols of Clinical Trials) has also been published discussing the rationale and supporting evidence for each checklist item and providing examples from actual protocols.
Chan A-W, Tetzlaff JM, Altman DG, Laupacis A, Gøtzsche PC, Krleža-Jerić K, Hróbjartsson A, Mann H, Dickersin K, Berlin J, Doré C, Parulekar W, Summerskill W, Groves T, Schulz K, Sox H, Rockhold FW, Rennie D, Moher D. SPIRIT 2013 Statement: Defining standard protocol items for clinical trials. Ann Intern Med 2013; Online first version.
Chan A-W, Tetzlaff JM, Gøtzsche PC, Altman DG, Mann H, Berlin J, Dickersin K, Hróbjartsson A, Schulz KF, Parulekar WR, Krleža-Jerić K, Laupacis A, Moher D. SPIRIT 2013 Explanation and Elaboration: Guidance for protocols of clinical trials. BMJ 2013;346:e7586.
A comment about SPIRIT 2013 has also been published in the Lancet:http://www.thelancet.com/journals/lancet/article/PIIS0140-6736%2812%2962160-6/fulltext?rss=yes
The SPIRIT website is available at: http://www.spirit-statement.org/