SPIRIT (Standard Protocol Items: Recommendations for Interventional Trials)
The SPIRIT 2013 Statement provides evidence-based recommendations for the minimum content of a clinical trial protocol. SPIRIT is widely endorsed as an international standard for trial protocols.
The recommendations are outlined in a 33-item checklist and figure. Each checklist item is detailed in the Explanation & Elaboration paper.
Key Documents
Online trial protocol template
Better content, faster registration
SEPTRE (SPIRIT Electronic Protocol Tool & Resource) is an innovative web-based tool that simplifies the creation, formatting, and registration of high-quality trial protocols. The SEPTRE protocol tool incorporates automation and the evidence-based SPIRIT guidance to strengthen the quality, efficiency, and transparency of clinical trials.
Please contact us for a demo and further details.
News & Updates
- SPIRIT-Outcomes extension now available in JAMA to guide reporting of outcomes-related information in protocols (December 2022)[spacer height=”20px” id=”2″]
- SPIRIT-Path extension: protocol guidance for reporting cellular and molecular pathology content — Lancet Oncology (October 2021)[spacer height=”20px” id=”2″]
- SPIRIT-PRO explanation and elaboration paper published (July 2021)[spacer height=”20px” id=”2″]
- CONSERVE Statement published in JAMA – guidance for trials modified by COVID-19 and other extenuating circumstances (June 2021) [spacer height=”20px” id=”2″]
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Japanese translations of SPIRIT-PRO and CONSORT-PRO published (January 2021)
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SPIRIT extension for N-of-1 trials (SPENT) published in BMJ (February 2020)
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Web-based SEPTRE clinical trial protocol tool is now available (February 2019)
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SPIRIT- TCM extension published for trials of traditional Chinese medicine (January 2019)
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French Translation [by Cochrane France] (July 2018)
last updated: April 1, 2022
Funders
