Developing Trial Protocols (Part 1 of 3)
(Week of December 15, 2025)
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Primary Content
Primary Content
Module 7-1: Using SPIRIT To Elevate Your Pragmatic Trial Protocol – Part 1 of 3 (19-Minute Video)
In this module, we walk through Part 1 of a three-part series on developing a pragmatic clinical trial protocol using the updated SPIRIT 2025 checklist.
Across the first 18 SPIRIT items, we unpack how to craft a clear, informative protocol title and structured summary, keep track of protocol versions, and define roles, responsibilities, and trial governance. We also cover open science practices, including trial registration, data sharing, funding declarations, conflicts of interest, and plans for returning results to communities and partners. You will see how to write a compelling background and rationale, specify objectives and hypotheses, describe interventions and comparators, define outcomes and harms, and build a practical participant timeline.
** The video's content and narration were generated with the assistance of artificial intelligence, with human guidance and oversight throughout the process. **
Curriculum Wheel
Curriculum Wheel
Additional Material
Additional Material
Protocol_Resources_Info_sheet.pdfKey Resources for Developing Trial Protocols
bmj-2024-081660.full.pdfSPIRIT 2025 explanation and elaboration: updated guideline for protocols of randomised trials
Abstract: High-quality protocols facilitate proper planning, conduct, reporting, and external review of randomised trials, yet their completeness varies, and key elements are often not considered. To strengthen good reporting of trial protocols, the SPIRIT (Standard Protocol Items: Recommendations for Interventional Trials) 2013 statement has been updated to incorporate new evidence and emerging perspectives. This SPIRIT 2025 explanation and elaboration document provides users with exemplars of reporting in contemporary trial protocols, contextual elaboration, more detailed guidance on reporting, references to key empirical studies, an expanded checklist, and a link to a website for further information. The document is intended to be used in conjunction with the SPIRIT 2025 statement and serves as a resource for researchers planning a trial and for others interested in trial protocols.
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