{"id":1913,"date":"2026-09-17T00:35:54","date_gmt":"2026-09-16T19:05:54","guid":{"rendered":"https:\/\/www.editage.com\/blog\/?p=1913"},"modified":"2026-08-26T09:22:52","modified_gmt":"2026-08-26T03:52:52","slug":"how-to-write-and-publish-a-study-protocol-meaning-examples-format","status":"publish","type":"post","link":"https:\/\/www.editage.com\/blog\/how-to-write-and-publish-a-study-protocol-meaning-examples-format\/","title":{"rendered":"How to Write and Publish a Study Protocol: Meaning, Examples, Format"},"content":{"rendered":"<p><strong>Key Takeaways:<\/strong><\/p>\n<ul>\n<li>A published protocol locks your methods into the public record before any data exist, which protects the study against later accusations of outcome switching and turns months of design work into a citable, peer-reviewed output.<\/li>\n<li>SPIRIT 2025 is now the reference standard for <a href=\"https:\/\/www.editage.com\/blog\/randomized-controlled-trial-rct\/\">randomized trial<\/a> protocols: 34 minimum items, a new open science section, expanded guidance on harms and intervention description, and a new item on patient and public involvement.<\/li>\n<li>Prospective registration and documented ethics approval are gatekeeping requirements at almost every journal; protocols submitted after recruitment has closed are routinely desk-rejected.<\/li>\n<li>Budget 4-8 months from first draft to publication, plus an article processing charge, and decide early whether a preprint or registry record would serve you just as well for free.<\/li>\n<\/ul>\n<div id=\"ez-toc-container\" class=\"ez-toc-v2_0_85 counter-hierarchy ez-toc-counter ez-toc-grey ez-toc-container-direction\">\n<div class=\"ez-toc-title-container\">\n<p class=\"ez-toc-title\" style=\"cursor:inherit\">Table of Contents<\/p>\n<span class=\"ez-toc-title-toggle\"><a href=\"#\" class=\"ez-toc-pull-right ez-toc-btn ez-toc-btn-xs ez-toc-btn-default ez-toc-toggle\" aria-label=\"Toggle Table of Content\"><span class=\"ez-toc-js-icon-con\"><span class=\"\"><span class=\"eztoc-hide\" style=\"display:none;\">Toggle<\/span><span class=\"ez-toc-icon-toggle-span\"><svg style=\"fill: #999;color:#999\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\" class=\"list-377408\" width=\"20px\" height=\"20px\" viewBox=\"0 0 24 24\" fill=\"none\"><path d=\"M6 6H4v2h2V6zm14 0H8v2h12V6zM4 11h2v2H4v-2zm16 0H8v2h12v-2zM4 16h2v2H4v-2zm16 0H8v2h12v-2z\" fill=\"currentColor\"><\/path><\/svg><svg style=\"fill: #999;color:#999\" class=\"arrow-unsorted-368013\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\" width=\"10px\" height=\"10px\" viewBox=\"0 0 24 24\" version=\"1.2\" baseProfile=\"tiny\"><path d=\"M18.2 9.3l-6.2-6.3-6.2 6.3c-.2.2-.3.4-.3.7s.1.5.3.7c.2.2.4.3.7.3h11c.3 0 .5-.1.7-.3.2-.2.3-.5.3-.7s-.1-.5-.3-.7zM5.8 14.7l6.2 6.3 6.2-6.3c.2-.2.3-.5.3-.7s-.1-.5-.3-.7c-.2-.2-.4-.3-.7-.3h-11c-.3 0-.5.1-.7.3-.2.2-.3.5-.3.7s.1.5.3.7z\"\/><\/svg><\/span><\/span><\/span><\/a><\/span><\/div>\n<nav><ul class='ez-toc-list ez-toc-list-level-1 ' ><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-1\" href=\"https:\/\/www.editage.com\/blog\/how-to-write-and-publish-a-study-protocol-meaning-examples-format\/#Glossary_of_Key_Terms\" >Glossary of Key Terms<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-2\" href=\"https:\/\/www.editage.com\/blog\/how-to-write-and-publish-a-study-protocol-meaning-examples-format\/#What_Is_a_Study_Protocol_and_Why_Publish_One\" >What Is a Study Protocol, and Why Publish One?<\/a><ul class='ez-toc-list-level-3' ><li class='ez-toc-heading-level-3'><a class=\"ez-toc-link ez-toc-heading-3\" href=\"https:\/\/www.editage.com\/blog\/how-to-write-and-publish-a-study-protocol-meaning-examples-format\/#Study_Protocol_vs_Grant_Application_Key_Differences\" >Study Protocol vs Grant Application: Key Differences<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-3'><a class=\"ez-toc-link ez-toc-heading-4\" href=\"https:\/\/www.editage.com\/blog\/how-to-write-and-publish-a-study-protocol-meaning-examples-format\/#Three_Documents_People_Confuse\" >Three Documents People Confuse<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-3'><a class=\"ez-toc-link ez-toc-heading-5\" href=\"https:\/\/www.editage.com\/blog\/how-to-write-and-publish-a-study-protocol-meaning-examples-format\/#Reasons_to_Publish\" >Reasons to Publish<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-3'><a class=\"ez-toc-link ez-toc-heading-6\" href=\"https:\/\/www.editage.com\/blog\/how-to-write-and-publish-a-study-protocol-meaning-examples-format\/#When_Is_Publishing_a_Protocol_Not_Worth_It\" >When Is Publishing a Protocol Not Worth It?<\/a><\/li><\/ul><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-7\" href=\"https:\/\/www.editage.com\/blog\/how-to-write-and-publish-a-study-protocol-meaning-examples-format\/#Groundwork_Before_You_Draft\" >Groundwork Before You Draft<\/a><ul class='ez-toc-list-level-3' ><li class='ez-toc-heading-level-3'><a class=\"ez-toc-link ez-toc-heading-8\" href=\"https:\/\/www.editage.com\/blog\/how-to-write-and-publish-a-study-protocol-meaning-examples-format\/#Locking_the_Research_Question\" >Locking the Research Question<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-3'><a class=\"ez-toc-link ez-toc-heading-9\" href=\"https:\/\/www.editage.com\/blog\/how-to-write-and-publish-a-study-protocol-meaning-examples-format\/#Team_Authorship_and_Sponsorship\" >Team, Authorship, and Sponsorship<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-3'><a class=\"ez-toc-link ez-toc-heading-10\" href=\"https:\/\/www.editage.com\/blog\/how-to-write-and-publish-a-study-protocol-meaning-examples-format\/#Do_You_Need_Ethics_Approval_Before_Submitting\" >Do You Need Ethics Approval Before Submitting?<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-3'><a class=\"ez-toc-link ez-toc-heading-11\" href=\"https:\/\/www.editage.com\/blog\/how-to-write-and-publish-a-study-protocol-meaning-examples-format\/#Prospective_Registration\" >Prospective Registration<\/a><\/li><\/ul><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-12\" href=\"https:\/\/www.editage.com\/blog\/how-to-write-and-publish-a-study-protocol-meaning-examples-format\/#Which_Reporting_Guideline_Applies_to_Your_Study\" >Which Reporting Guideline Applies to Your Study?<\/a><ul class='ez-toc-list-level-3' ><li class='ez-toc-heading-level-3'><a class=\"ez-toc-link ez-toc-heading-13\" href=\"https:\/\/www.editage.com\/blog\/how-to-write-and-publish-a-study-protocol-meaning-examples-format\/#Using_a_Checklist_Properly\" >Using a Checklist Properly<\/a><\/li><\/ul><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-14\" href=\"https:\/\/www.editage.com\/blog\/how-to-write-and-publish-a-study-protocol-meaning-examples-format\/#Structure_and_Contents_of_the_Protocol_Manuscript\" >Structure and Contents of the Protocol Manuscript<\/a><ul class='ez-toc-list-level-3' ><li class='ez-toc-heading-level-3'><a class=\"ez-toc-link ez-toc-heading-15\" href=\"https:\/\/www.editage.com\/blog\/how-to-write-and-publish-a-study-protocol-meaning-examples-format\/#Title_and_Abstract\" >Title and Abstract<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-3'><a class=\"ez-toc-link ez-toc-heading-16\" href=\"https:\/\/www.editage.com\/blog\/how-to-write-and-publish-a-study-protocol-meaning-examples-format\/#Administrative_Information\" >Administrative Information<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-3'><a class=\"ez-toc-link ez-toc-heading-17\" href=\"https:\/\/www.editage.com\/blog\/how-to-write-and-publish-a-study-protocol-meaning-examples-format\/#Introduction\" >Introduction<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-3'><a class=\"ez-toc-link ez-toc-heading-18\" href=\"https:\/\/www.editage.com\/blog\/how-to-write-and-publish-a-study-protocol-meaning-examples-format\/#Methods_Design_Setting_and_Participants\" >Methods: Design, Setting, and Participants<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-3'><a class=\"ez-toc-link ez-toc-heading-19\" href=\"https:\/\/www.editage.com\/blog\/how-to-write-and-publish-a-study-protocol-meaning-examples-format\/#Methods_Interventions_and_Comparators\" >Methods: Interventions and Comparators<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-3'><a class=\"ez-toc-link ez-toc-heading-20\" href=\"https:\/\/www.editage.com\/blog\/how-to-write-and-publish-a-study-protocol-meaning-examples-format\/#Methods_Outcomes_and_Participant_Timeline\" >Methods: Outcomes and Participant Timeline<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-3'><a class=\"ez-toc-link ez-toc-heading-21\" href=\"https:\/\/www.editage.com\/blog\/how-to-write-and-publish-a-study-protocol-meaning-examples-format\/#How_Do_You_Justify_a_Sample_Size\" >How Do You Justify a Sample Size?<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-3'><a class=\"ez-toc-link ez-toc-heading-22\" href=\"https:\/\/www.editage.com\/blog\/how-to-write-and-publish-a-study-protocol-meaning-examples-format\/#Methods_Allocation_Blinding_and_Bias_Control\" >Methods: Allocation, Blinding, and Bias Control<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-3'><a class=\"ez-toc-link ez-toc-heading-23\" href=\"https:\/\/www.editage.com\/blog\/how-to-write-and-publish-a-study-protocol-meaning-examples-format\/#Methods_Data_Collection_and_Management\" >Methods: Data Collection and Management<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-3'><a class=\"ez-toc-link ez-toc-heading-24\" href=\"https:\/\/www.editage.com\/blog\/how-to-write-and-publish-a-study-protocol-meaning-examples-format\/#Methods_Statistical_Analysis_Plan\" >Methods: Statistical Analysis Plan<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-3'><a class=\"ez-toc-link ez-toc-heading-25\" href=\"https:\/\/www.editage.com\/blog\/how-to-write-and-publish-a-study-protocol-meaning-examples-format\/#Methods_Harms_Safety_and_Monitoring\" >Methods: Harms, Safety, and Monitoring<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-3'><a class=\"ez-toc-link ez-toc-heading-26\" href=\"https:\/\/www.editage.com\/blog\/how-to-write-and-publish-a-study-protocol-meaning-examples-format\/#Ethics_and_Dissemination\" >Ethics and Dissemination<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-3'><a class=\"ez-toc-link ez-toc-heading-27\" href=\"https:\/\/www.editage.com\/blog\/how-to-write-and-publish-a-study-protocol-meaning-examples-format\/#Discussion\" >Discussion<\/a><\/li><\/ul><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-28\" href=\"https:\/\/www.editage.com\/blog\/how-to-write-and-publish-a-study-protocol-meaning-examples-format\/#Supporting_Documents_That_Travel_With_the_Protocol\" >Supporting Documents That Travel With the Protocol<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-29\" href=\"https:\/\/www.editage.com\/blog\/how-to-write-and-publish-a-study-protocol-meaning-examples-format\/#Where_Should_You_Publish_a_Study_Protocol\" >Where Should You Publish a Study Protocol?<\/a><ul class='ez-toc-list-level-3' ><li class='ez-toc-heading-level-3'><a class=\"ez-toc-link ez-toc-heading-30\" href=\"https:\/\/www.editage.com\/blog\/how-to-write-and-publish-a-study-protocol-meaning-examples-format\/#Registered_Reports_as_an_Alternative_Route\" >Registered Reports as an Alternative Route<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-3'><a class=\"ez-toc-link ez-toc-heading-31\" href=\"https:\/\/www.editage.com\/blog\/how-to-write-and-publish-a-study-protocol-meaning-examples-format\/#Free_Alternatives_Worth_Considering\" >Free Alternatives Worth Considering<\/a><\/li><\/ul><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-32\" href=\"https:\/\/www.editage.com\/blog\/how-to-write-and-publish-a-study-protocol-meaning-examples-format\/#Preparing_the_Submission\" >Preparing the Submission<\/a><ul class='ez-toc-list-level-3' ><li class='ez-toc-heading-level-3'><a class=\"ez-toc-link ez-toc-heading-33\" href=\"https:\/\/www.editage.com\/blog\/how-to-write-and-publish-a-study-protocol-meaning-examples-format\/#The_Cover_Letter\" >The Cover Letter<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-3'><a class=\"ez-toc-link ez-toc-heading-34\" href=\"https:\/\/www.editage.com\/blog\/how-to-write-and-publish-a-study-protocol-meaning-examples-format\/#What_Do_Editors_Check_First\" >What Do Editors Check First?<\/a><\/li><\/ul><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-35\" href=\"https:\/\/www.editage.com\/blog\/how-to-write-and-publish-a-study-protocol-meaning-examples-format\/#Why_Do_Protocol_Manuscripts_Get_Rejected\" >Why Do Protocol Manuscripts Get Rejected?<\/a><ul class='ez-toc-list-level-3' ><li class='ez-toc-heading-level-3'><a class=\"ez-toc-link ez-toc-heading-36\" href=\"https:\/\/www.editage.com\/blog\/how-to-write-and-publish-a-study-protocol-meaning-examples-format\/#Writing_the_Point-by-Point_Response\" >Writing the Point-by-Point Response<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-3'><a class=\"ez-toc-link ez-toc-heading-37\" href=\"https:\/\/www.editage.com\/blog\/how-to-write-and-publish-a-study-protocol-meaning-examples-format\/#Handling_a_Desk_Rejection\" >Handling a Desk Rejection<\/a><\/li><\/ul><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-38\" href=\"https:\/\/www.editage.com\/blog\/how-to-write-and-publish-a-study-protocol-meaning-examples-format\/#After_Publication\" >After Publication<\/a><ul class='ez-toc-list-level-3' ><li class='ez-toc-heading-level-3'><a class=\"ez-toc-link ez-toc-heading-39\" href=\"https:\/\/www.editage.com\/blog\/how-to-write-and-publish-a-study-protocol-meaning-examples-format\/#Amendments_and_Version_Control\" >Amendments and Version Control<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-3'><a class=\"ez-toc-link ez-toc-heading-40\" href=\"https:\/\/www.editage.com\/blog\/how-to-write-and-publish-a-study-protocol-meaning-examples-format\/#Linking_Protocol_Registry_and_Results\" >Linking Protocol, Registry, and Results<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-3'><a class=\"ez-toc-link ez-toc-heading-41\" href=\"https:\/\/www.editage.com\/blog\/how-to-write-and-publish-a-study-protocol-meaning-examples-format\/#Dissemination\" >Dissemination<\/a><\/li><\/ul><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-42\" href=\"https:\/\/www.editage.com\/blog\/how-to-write-and-publish-a-study-protocol-meaning-examples-format\/#Toolkit_Timelines_Targets_and_Checklists\" >Toolkit: Timelines, Targets, and Checklists<\/a><ul class='ez-toc-list-level-3' ><li class='ez-toc-heading-level-3'><a class=\"ez-toc-link ez-toc-heading-43\" href=\"https:\/\/www.editage.com\/blog\/how-to-write-and-publish-a-study-protocol-meaning-examples-format\/#How_Long_Does_the_Whole_Process_Take\" >How Long Does the Whole Process Take?<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-3'><a class=\"ez-toc-link ez-toc-heading-44\" href=\"https:\/\/www.editage.com\/blog\/how-to-write-and-publish-a-study-protocol-meaning-examples-format\/#How_Long_Should_Each_Section_Be\" >How Long Should Each Section Be?<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-3'><a class=\"ez-toc-link ez-toc-heading-45\" href=\"https:\/\/www.editage.com\/blog\/how-to-write-and-publish-a-study-protocol-meaning-examples-format\/#Common_Pitfalls\" >Common Pitfalls<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-3'><a class=\"ez-toc-link ez-toc-heading-46\" href=\"https:\/\/www.editage.com\/blog\/how-to-write-and-publish-a-study-protocol-meaning-examples-format\/#Pre-Submission_Checklist\" >Pre-Submission Checklist<\/a><\/li><\/ul><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-47\" href=\"https:\/\/www.editage.com\/blog\/how-to-write-and-publish-a-study-protocol-meaning-examples-format\/#Key_Resources\" >Key Resources<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-48\" href=\"https:\/\/www.editage.com\/blog\/how-to-write-and-publish-a-study-protocol-meaning-examples-format\/#Frequently_Asked_Questions\" >Frequently Asked Questions<\/a><ul class='ez-toc-list-level-3' ><li class='ez-toc-heading-level-3'><a class=\"ez-toc-link ez-toc-heading-49\" href=\"https:\/\/www.editage.com\/blog\/how-to-write-and-publish-a-study-protocol-meaning-examples-format\/#What_Is_the_Difference_Between_a_Study_Protocol_and_a_Research_Proposal\" >What Is the Difference Between a Study Protocol and a Research Proposal?<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-3'><a class=\"ez-toc-link ez-toc-heading-50\" href=\"https:\/\/www.editage.com\/blog\/how-to-write-and-publish-a-study-protocol-meaning-examples-format\/#Can_You_Publish_a_Study_Protocol_After_Data_Collection_Has_Started\" >Can You Publish a Study Protocol After Data Collection Has Started?<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-3'><a class=\"ez-toc-link ez-toc-heading-51\" href=\"https:\/\/www.editage.com\/blog\/how-to-write-and-publish-a-study-protocol-meaning-examples-format\/#Is_a_Published_Study_Protocol_Counted_as_a_Peer-Reviewed_Publication\" >Is a Published Study Protocol Counted as a Peer-Reviewed Publication?<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-3'><a class=\"ez-toc-link ez-toc-heading-52\" href=\"https:\/\/www.editage.com\/blog\/how-to-write-and-publish-a-study-protocol-meaning-examples-format\/#How_Much_Does_It_Cost_to_Publish_a_Study_Protocol\" >How Much Does It Cost to Publish a Study Protocol?<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-3'><a class=\"ez-toc-link ez-toc-heading-53\" href=\"https:\/\/www.editage.com\/blog\/how-to-write-and-publish-a-study-protocol-meaning-examples-format\/#Do_You_Need_Ethics_Approval_Before_Publishing_a_Study_Protocol\" >Do You Need Ethics Approval Before Publishing a Study Protocol?<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-3'><a class=\"ez-toc-link ez-toc-heading-54\" href=\"https:\/\/www.editage.com\/blog\/how-to-write-and-publish-a-study-protocol-meaning-examples-format\/#How_Long_Should_a_Study_Protocol_Paper_Be\" >How Long Should a Study Protocol Paper Be?<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-3'><a class=\"ez-toc-link ez-toc-heading-55\" href=\"https:\/\/www.editage.com\/blog\/how-to-write-and-publish-a-study-protocol-meaning-examples-format\/#Can_You_Publish_a_Protocol_for_a_Systematic_Review_or_Meta-Analysis\" >Can You Publish a Protocol for a Systematic Review or Meta-Analysis?<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-3'><a class=\"ez-toc-link ez-toc-heading-56\" href=\"https:\/\/www.editage.com\/blog\/how-to-write-and-publish-a-study-protocol-meaning-examples-format\/#What_Happens_If_Your_Study_Deviates_From_the_Published_Protocol\" >What Happens If Your Study Deviates From the Published Protocol?<\/a><\/li><\/ul><\/li><\/ul><\/nav><\/div>\n<h2><span class=\"ez-toc-section\" id=\"Glossary_of_Key_Terms\"><\/span>Glossary of Key Terms<span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p>&nbsp;<\/p>\n<table width=\"624\">\n<thead>\n<tr>\n<td width=\"160\"><strong>Term<\/strong><\/td>\n<td width=\"464\"><strong>What It Means<\/strong><\/td>\n<\/tr>\n<\/thead>\n<tbody>\n<tr>\n<td width=\"160\">Allocation concealment<\/td>\n<td width=\"464\">The mechanism that stops anyone from knowing which group the next enrolled participant will receive, for example a central web randomization service.<\/td>\n<\/tr>\n<tr>\n<td width=\"160\">Amendment<\/td>\n<td width=\"464\">A documented, dated change to an approved protocol, usually requiring re-approval by the ethics committee and an update to the registry record.<\/td>\n<\/tr>\n<tr>\n<td width=\"160\">APC<\/td>\n<td width=\"464\">Article processing charge: the fee an open access journal charges once a manuscript is accepted.<\/td>\n<\/tr>\n<tr>\n<td width=\"160\">Blinding (masking)<\/td>\n<td width=\"464\">Withholding group assignment from participants, care providers, outcome assessors, or analysts to reduce bias.<\/td>\n<\/tr>\n<tr>\n<td width=\"160\">CRF<\/td>\n<td width=\"464\">Case report form: the structured instrument used to capture data for each participant.<\/td>\n<\/tr>\n<tr>\n<td width=\"160\">DMC or DSMB<\/td>\n<td width=\"464\">Data monitoring committee or data and safety monitoring board: an independent group that reviews accumulating safety and efficacy data.<\/td>\n<\/tr>\n<tr>\n<td width=\"160\">EQUATOR Network<\/td>\n<td width=\"464\">An online library that indexes reporting guidelines by study design.<\/td>\n<\/tr>\n<tr>\n<td width=\"160\">Estimand<\/td>\n<td width=\"464\">A precise definition of the treatment effect being estimated, including population, endpoint, and handling of events that occur after randomization.<\/td>\n<\/tr>\n<tr>\n<td width=\"160\">ICMJE<\/td>\n<td width=\"464\">International Committee of Medical Journal Editors, whose recommendations set authorship criteria and the prospective registration rule.<\/td>\n<\/tr>\n<tr>\n<td width=\"160\">In-principle acceptance<\/td>\n<td width=\"464\">A commitment by a journal to publish a Registered Report regardless of results, granted after the methods pass peer review.<\/td>\n<\/tr>\n<tr>\n<td width=\"160\"><a href=\"https:\/\/www.editage.com\/blog\/what-is-the-pico-framework-in-research-definition-uses-examples\/\">PICO<\/a><\/td>\n<td width=\"464\">Population, Intervention, Comparator, Outcome: a framework for structuring an answerable clinical question.<\/td>\n<\/tr>\n<tr>\n<td width=\"160\">PPI<\/td>\n<td width=\"464\">Patient and public involvement: research done with or by patients and the public rather than about them.<\/td>\n<\/tr>\n<tr>\n<td width=\"160\"><a href=\"https:\/\/www.editage.com\/blog\/what-is-a-preprint\/\">Preprint<\/a><\/td>\n<td width=\"464\">A manuscript posted publicly before or during <a href=\"https:\/\/www.editage.com\/blog\/peer-review-definition-types-process-timelines\/\">peer review<\/a>, on a server such as medRxiv or OSF Preprints.<\/td>\n<\/tr>\n<tr>\n<td width=\"160\">Primary outcome<\/td>\n<td width=\"464\">The single outcome that the study is powered to detect and on which its main conclusion rests.<\/td>\n<\/tr>\n<tr>\n<td width=\"160\">PROSPERO<\/td>\n<td width=\"464\">The international prospective register of systematic reviews.<\/td>\n<\/tr>\n<tr>\n<td width=\"160\">Prospective registration<\/td>\n<td width=\"464\">Entering the study in a public registry before the first participant is enrolled or the first record is screened.<\/td>\n<\/tr>\n<tr>\n<td width=\"160\">Protocol manuscript<\/td>\n<td width=\"464\">The condensed, journal-formatted version of the full protocol, written for publication.<\/td>\n<\/tr>\n<tr>\n<td width=\"160\"><a href=\"https:\/\/www.editage.com\/blog\/registered-report-structure-checklist-examples\/\">Registered Report<\/a><\/td>\n<td width=\"464\">A publication format in which methods are peer reviewed before data collection and acceptance is granted in advance.<\/td>\n<\/tr>\n<tr>\n<td width=\"160\">SAP<\/td>\n<td width=\"464\">Statistical analysis plan: a standalone, versioned document specifying every planned analysis in detail.<\/td>\n<\/tr>\n<tr>\n<td width=\"160\">SPIRIT<\/td>\n<td width=\"464\">Standard Protocol Items: Recommendations for Interventional Trials, the reporting guideline for trial protocols.<\/td>\n<\/tr>\n<tr>\n<td width=\"160\">Sponsor<\/td>\n<td width=\"464\">The organization that takes legal responsibility for the initiation, management, and financing of the study.<\/td>\n<\/tr>\n<tr>\n<td width=\"160\">TIDieR<\/td>\n<td width=\"464\">Template for Intervention Description and Replication: a checklist for describing interventions in enough detail to reproduce them.<\/td>\n<\/tr>\n<tr>\n<td width=\"160\">Version control<\/td>\n<td width=\"464\">Systematic numbering and dating of protocol drafts so that any reader can identify which version governed which phase of the study.<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<p>&nbsp;<\/p>\n<h2><span class=\"ez-toc-section\" id=\"What_Is_a_Study_Protocol_and_Why_Publish_One\"><\/span>What Is a Study Protocol, and Why Publish One?<span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p>A study protocol is a prespecified, dated, version-controlled plan that states why a study is being done, how it will be conducted, and by whom. Publishing it makes that plan public and citable before any results exist.<\/p>\n<p>The protocol is the reference document against which everyone later judges the study. Funders read it to check value for money, ethics committees read it to check participant protection, statisticians read it to confirm the analysis was prespecified, and reviewers of the eventual results paper read it to check that nothing quietly changed along the way.<\/p>\n<h3><span class=\"ez-toc-section\" id=\"Study_Protocol_vs_Grant_Application_Key_Differences\"><\/span>Study Protocol vs Grant Application: Key Differences<span class=\"ez-toc-section-end\"><\/span><\/h3>\n<p>A grant application argues that a study is worth funding. A protocol specifies exactly how the study will be executed, in enough operational detail that another team could run it.<\/p>\n<p>The 2 documents overlap heavily in background and rationale, and reusing that text is sensible. They diverge sharply in the methods. A funder tolerates a sentence such as &#8220;participants will be randomized using standard methods.&#8221; A protocol reader will not: they need the sequence generation method, the concealment mechanism, the block structure, the stratification factors, and the name of the person who holds the allocation list.<\/p>\n<h3><span class=\"ez-toc-section\" id=\"Three_Documents_People_Confuse\"><\/span>Three Documents People Confuse<span class=\"ez-toc-section-end\"><\/span><\/h3>\n<p>Most confusion in protocol writing comes from treating these as interchangeable. They are not: they have different audiences, lengths, and update cycles.<\/p>\n<table width=\"624\">\n<thead>\n<tr>\n<td width=\"133\"><strong>Document<\/strong><\/td>\n<td width=\"160\"><strong>Primary Audience<\/strong><\/td>\n<td width=\"331\"><strong>What It Contains<\/strong><\/td>\n<\/tr>\n<\/thead>\n<tbody>\n<tr>\n<td width=\"133\">Master protocol<\/td>\n<td width=\"160\">Ethics committee, sponsor, regulator, site staff<\/td>\n<td width=\"331\">The full operational document, often 40-90 pages, including standard operating procedures, consent forms, appendices, and every safety definition. Updated by formal amendment.<\/td>\n<\/tr>\n<tr>\n<td width=\"133\">Registry record<\/td>\n<td width=\"160\">Public, systematic reviewers, journal editors<\/td>\n<td width=\"331\">A structured summary in fixed fields: eligibility, arms, outcomes with timepoints, recruitment status, and a unique identifier. Updated whenever the design or status changes.<\/td>\n<\/tr>\n<tr>\n<td width=\"133\">Protocol manuscript<\/td>\n<td width=\"160\">Journal readers and peer reviewers<\/td>\n<td width=\"331\">A condensed narrative of 3,500-5,000 words presenting rationale and methods for a scientific audience, with the checklist and long appendices as supplementary files.<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<p>&nbsp;<\/p>\n<p>Write the master protocol first. The manuscript is then an editorial exercise: cutting, not inventing. Teams that write the manuscript first almost always discover unresolved design decisions during ethics review.<\/p>\n<h3><span class=\"ez-toc-section\" id=\"Reasons_to_Publish\"><\/span>Reasons to Publish<span class=\"ez-toc-section-end\"><\/span><\/h3>\n<ul>\n<li>Prespecification is made verifiable. A timestamped, peer-reviewed record of your primary outcome and analysis plan is the strongest available defense against suspicion of selective reporting.<\/li>\n<li>You get methodological peer review while it is still free to act on it. Reviewer comments on methodological choices that arrive before recruitment can be implemented fairly quickly and easily compared to reviewer comments on the methodology once the study is completed and submitted for publication.<\/li>\n<li>Design work becomes a citable output. For early-career researchers and for teams whose main results are 3-5 years away, this matters for promotion and reporting cycles.<\/li>\n<li>Duplication is reduced. Other groups can see that the question is already being addressed, at what scale, and in what population.<\/li>\n<li>Recruitment of collaborators, sites, and patient partners becomes easier when there is a public document to circulate.<\/li>\n<li>The manuscript reporting the study results becomes faster to write, because the methods section can be compressed and cross-referenced to the published protocol.<\/li>\n<li>Some funders and sponsors now expect or mandate it, particularly for publicly funded trials.<\/li>\n<\/ul>\n<h3><span class=\"ez-toc-section\" id=\"When_Is_Publishing_a_Protocol_Not_Worth_It\"><\/span>When Is Publishing a Protocol Not Worth It?<span class=\"ez-toc-section-end\"><\/span><\/h3>\n<p>Skip it when recruitment is already complete, when the work is internal audit or quality improvement, or when the fee buys you nothing that a free registry record and preprint would not.<\/p>\n<ul>\n<li>Recruitment has closed or data collection has finished. Most protocol journals explicitly refuse these, and publishing one anyway invites suspicion.<\/li>\n<li>The study is small, local, and unlikely to be replicated or synthesized, such as a single-site service evaluation.<\/li>\n<li>The field is highly competitive and disclosing the design early would materially damage the team, though note that registration is still usually mandatory.<\/li>\n<li>The design is still unstable. Publishing a protocol you expect to rewrite creates a public trail of discrepancies you will have to explain later.<\/li>\n<li>There is no budget for an APC. A registry record plus a preprint or an OSF-deposited protocol delivers most of the transparency benefit at no cost.<\/li>\n<\/ul>\n<h2><span class=\"ez-toc-section\" id=\"Groundwork_Before_You_Draft\"><\/span>Groundwork Before You Draft<span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p>Roughly half the reviewer criticism protocols attract is traceable to decisions made, or avoided, before anyone opened a document. Settle the following first.<\/p>\n<h3><span class=\"ez-toc-section\" id=\"Locking_the_Research_Question\"><\/span>Locking the Research Question<span class=\"ez-toc-section-end\"><\/span><\/h3>\n<p>An answerable <a href=\"https:\/\/researcher.life\/blog\/article\/how-to-craft-a-strong-research-question-with-research-question-examples\/\">research question<\/a> fixes the population, the exposure or intervention, the comparison, and the outcome. If any of the 4 is still negotiable, the <a href=\"https:\/\/www.editage.com\/blog\/sample-size-and-statistical-power-definition-formulas-calculations-worked-examples\/\">sample size calculation<\/a> cannot be trusted.<\/p>\n<table width=\"624\">\n<thead>\n<tr>\n<td width=\"100\"><strong>Framework<\/strong><\/td>\n<td width=\"244\"><strong>Best Suited To<\/strong><\/td>\n<td width=\"280\"><strong>Elements<\/strong><\/td>\n<\/tr>\n<\/thead>\n<tbody>\n<tr>\n<td width=\"100\">PICO<\/td>\n<td width=\"244\">Interventional studies and <a href=\"https:\/\/www.editage.com\/blog\/conducting-and-reporting-systematic-reviews\/\">systematic reviews<\/a> of effectiveness<\/td>\n<td width=\"280\">Population, Intervention, Comparator, Outcome<\/td>\n<\/tr>\n<tr>\n<td width=\"100\">PICOTS<\/td>\n<td width=\"244\">Trials where duration and setting are decisive<\/td>\n<td width=\"280\">Population, Intervention, Comparator, Outcome, Timeframe, Setting<\/td>\n<\/tr>\n<tr>\n<td width=\"100\">PECO<\/td>\n<td width=\"244\">Observational and environmental epidemiology<\/td>\n<td width=\"280\">Population, Exposure, Comparator, Outcome<\/td>\n<\/tr>\n<tr>\n<td width=\"100\">SPIDER<\/td>\n<td width=\"244\">Qualitative and mixed methods studies<\/td>\n<td width=\"280\">Sample, Phenomenon of Interest, Design, Evaluation, Research type<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<p>&nbsp;<\/p>\n<p>Write the question out as a single sentence and then check that every element of it reappears verbatim in your eligibility criteria, your outcome definitions, and your registry record. Silent drift between these 3 places is the most common internal inconsistency reviewers find.<\/p>\n<h3><span class=\"ez-toc-section\" id=\"Team_Authorship_and_Sponsorship\"><\/span>Team, Authorship, and Sponsorship<span class=\"ez-toc-section-end\"><\/span><\/h3>\n<p><a href=\"https:\/\/www.editage.com\/blog\/first-author-vs-corresponding-author-in-a-research-paper-how-to-decide-authorship-with-examples-templates\/#How_to_Resolve_Common_Authorship_Disputes\">Authorship disputes<\/a> on protocol papers are common because the paper appears years before the results, and contribution patterns shift. Agree the following in writing at the outset.<\/p>\n<ul>\n<li>Apply the 4 ICMJE criteria explicitly: substantial contribution to design or data, drafting or critical revision, final approval, and accountability for the work.<\/li>\n<li>Decide whether the protocol paper and the results paper will share an <a href=\"https:\/\/www.editage.com\/blog\/first-author-vs-corresponding-author-in-a-research-paper-how-to-decide-authorship-with-examples-templates\/#How_to_Decide_Author_Order\">author order<\/a>, and record the decision.<\/li>\n<li>Name a <a href=\"https:\/\/www.editage.com\/blog\/first-author-vs-corresponding-author-in-a-research-paper-how-to-decide-authorship-with-examples-templates\/#What_Are_the_Duties_of_a_Corresponding_Author\">corresponding author<\/a> who will still be reachable when the results appear.<\/li>\n<li>Identify the sponsor, which is a legal role, not a funding role, and state whether the sponsor had any part in the design.<\/li>\n<li>Register a group authorship name if the study has a large collaborative network, and confirm the target journal indexes group authors.<\/li>\n<li>Agree on a publication policy covering secondary analyses, site-level publications, and data access requests.<\/li>\n<\/ul>\n<h3><span class=\"ez-toc-section\" id=\"Do_You_Need_Ethics_Approval_Before_Submitting\"><\/span>Do You Need Ethics Approval Before Submitting?<span class=\"ez-toc-section-end\"><\/span><\/h3>\n<p>In almost all cases, yes. Journals expect a formal approval, or a documented exemption, with the committee name and reference number stated in the manuscript before they will send it out for review.<\/p>\n<p>Plan the sequence deliberately. Ethics committees review the master protocol, not the manuscript, and their required changes frequently alter eligibility criteria, consent procedures, or safety reporting. Submitting the manuscript first means rewriting it. The usual order is: finalize master protocol, obtain approval, register, then adapt the approved version into a manuscript, citing the approved version number and date.<\/p>\n<p>Multi-site studies add a further constraint. Some journals want approval from the lead site only; others expect confirmation that all participating sites are covered. Check the author instructions before assuming.<\/p>\n<h3><span class=\"ez-toc-section\" id=\"Prospective_Registration\"><\/span>Prospective Registration<span class=\"ez-toc-section-end\"><\/span><\/h3>\n<p>Registration must precede enrollment. The ICMJE rule is that member journals will not consider a trial for publication unless it was registered before the first participant was enrolled. Retrospective registration rarely protects your results manuscript from being <a href=\"https:\/\/www.editage.com\/blog\/desk-rejection-reasons-next-steps-and-how-to-avoid-rejection-without-peer-review\/\">desk rejected<\/a>.<\/p>\n<table width=\"624\">\n<thead>\n<tr>\n<td width=\"127\"><strong>Registry<\/strong><\/td>\n<td width=\"193\"><strong>Covers<\/strong><\/td>\n<td width=\"304\"><strong>Notes<\/strong><\/td>\n<\/tr>\n<\/thead>\n<tbody>\n<tr>\n<td width=\"127\">ClinicalTrials.gov<\/td>\n<td width=\"193\">Interventional and observational studies, worldwide<\/td>\n<td width=\"304\">The largest registry and the default for most international submissions. Requires an organization account.<\/td>\n<\/tr>\n<tr>\n<td width=\"127\">CTRI<\/td>\n<td width=\"193\">Studies conducted in India<\/td>\n<td width=\"304\">Registration is mandatory for clinical trials in India and is expected by Indian ethics committees and journals.<\/td>\n<\/tr>\n<tr>\n<td width=\"127\">ISRCTN<\/td>\n<td width=\"193\">Interventional and observational health studies<\/td>\n<td width=\"304\">Charges a registration fee. Widely accepted; common in the UK and Europe.<\/td>\n<\/tr>\n<tr>\n<td width=\"127\">ANZCTR<\/td>\n<td width=\"193\">Studies in Australia and New Zealand<\/td>\n<td width=\"304\">Free, well curated, and accepted internationally.<\/td>\n<\/tr>\n<tr>\n<td width=\"127\">PROSPERO<\/td>\n<td width=\"193\">Systematic reviews with a health-related outcome<\/td>\n<td width=\"304\">Free. Register before screening begins. Does not accept scoping reviews.<\/td>\n<\/tr>\n<tr>\n<td width=\"127\">OSF Registries<\/td>\n<td width=\"193\">Any design, including preclinical, psychological, and qualitative work<\/td>\n<td width=\"304\">Free and flexible, with time-stamped, embargo-capable registrations. The usual home for designs no clinical registry accepts.<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<p>&nbsp;<\/p>\n<p>Keep the registry record synchronized with the protocol from day 1. Reviewers and editors compare the 2 directly, and a primary outcome that differs between them is among the fastest routes to rejection.<\/p>\n<h2><span class=\"ez-toc-section\" id=\"Which_Reporting_Guideline_Applies_to_Your_Study\"><\/span>Which Reporting Guideline Applies to Your Study?<span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p>Match the guideline to the design. SPIRIT 2025 governs randomized trial protocols; PRISMA-P governs systematic review protocols; other designs have their own checklists, indexed by the EQUATOR Network.<\/p>\n<p>SPIRIT 2025 replaced the 2013 statement and consists of 34 minimum items plus a diagram showing the schedule of enrollment, interventions, and assessments. The substantive additions relative to 2013 are a dedicated open science section, stronger requirements around harms and around describing interventions and comparators, and a new item on how patients and the public will be involved in design, conduct, and reporting.<\/p>\n<table width=\"624\">\n<thead>\n<tr>\n<td width=\"173\"><strong>Study Design<\/strong><\/td>\n<td width=\"160\"><strong>Protocol Guideline<\/strong><\/td>\n<td width=\"291\"><strong>Notes<\/strong><\/td>\n<\/tr>\n<\/thead>\n<tbody>\n<tr>\n<td width=\"173\">Randomized controlled trial<\/td>\n<td width=\"160\">SPIRIT 2025<\/td>\n<td width=\"291\">Use with the relevant extensions: Outcomes, Harms, PRO, AI, and non-pharmacological treatment.<\/td>\n<\/tr>\n<tr>\n<td width=\"173\">Systematic review or meta-analysis<\/td>\n<td width=\"160\">PRISMA-P<\/td>\n<td width=\"291\">Pair with PROSPERO registration. PRISMA 2020 governs the eventual review, not the protocol.<\/td>\n<\/tr>\n<tr>\n<td width=\"173\">Observational cohort, case-control, cross-sectional<\/td>\n<td width=\"160\">STROBE, adapted prospectively<\/td>\n<td width=\"291\">No dedicated protocol checklist exists; write the protocol against STROBE items in the future tense.<\/td>\n<\/tr>\n<tr>\n<td width=\"173\">Diagnostic accuracy study<\/td>\n<td width=\"160\">STARD, adapted prospectively<\/td>\n<td width=\"291\">Specify index test, reference standard, and blinding of test readers.<\/td>\n<\/tr>\n<tr>\n<td width=\"173\">Prediction model development or validation<\/td>\n<td width=\"160\">TRIPOD+AI<\/td>\n<td width=\"291\">Prespecify candidate predictors, sample size, and the approach to model calibration.<\/td>\n<\/tr>\n<tr>\n<td width=\"173\">Qualitative study<\/td>\n<td width=\"160\">COREQ or SRQR, adapted<\/td>\n<td width=\"291\">Prespecify <a href=\"https:\/\/www.editage.com\/blog\/sampling-methods-in-research-probability-vs-non-probability-sampling-techniques-and-examples\/\">sampling technique<\/a>, analytic approach, and how sufficiency of data will be judged.<\/td>\n<\/tr>\n<tr>\n<td width=\"173\">Economic evaluation<\/td>\n<td width=\"160\">CHEERS<\/td>\n<td width=\"291\">State the perspective, time horizon, discount rate, and source of cost data.<\/td>\n<\/tr>\n<tr>\n<td width=\"173\">Pilot or feasibility study<\/td>\n<td width=\"160\">CONSORT extension for pilot trials<\/td>\n<td width=\"291\">Progression criteria must be numeric and prespecified, not descriptive.<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<p>&nbsp;<\/p>\n<h3><span class=\"ez-toc-section\" id=\"Using_a_Checklist_Properly\"><\/span>Using a Checklist Properly<span class=\"ez-toc-section-end\"><\/span><\/h3>\n<ul>\n<li>Open the checklist before drafting, not after. Retrofitting produces documents that technically address every item while burying half of them in one dense paragraph.<\/li>\n<li>Read the explanation and elaboration document alongside the statement. It contains the worked examples that show what an adequate answer looks like.<\/li>\n<li>Complete the checklist with page or section numbers, not ticks. Editors check these.<\/li>\n<li>Treat items you genuinely cannot address as content, not omissions: state that the item does not apply and say why.<\/li>\n<li>Apply extensions cumulatively. A trial of a digital behavioral intervention may need SPIRIT 2025 plus TIDieR plus the AI extension.<\/li>\n<\/ul>\n<h2><span class=\"ez-toc-section\" id=\"Structure_and_Contents_of_the_Protocol_Manuscript\"><\/span>Structure and Contents of the Protocol Manuscript<span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p>What follows is a section-by-section walkthrough in the order most journals expect. The proportions matter: methods should occupy roughly 60-70% of the total word count.<\/p>\n<h3><span class=\"ez-toc-section\" id=\"Title_and_Abstract\"><\/span>Title and Abstract<span class=\"ez-toc-section-end\"><\/span><\/h3>\n<ul>\n<li>Name the design in the <a href=\"https:\/\/www.editage.com\/blog\/title-research-paper\/\">title<\/a>, using the exact label: randomized controlled trial, prospective cohort study, systematic review and meta-analysis.<\/li>\n<li>Include the phrase &#8220;study protocol&#8221; or &#8220;protocol for&#8221; so the article type is unambiguous in search results and citations.<\/li>\n<li>State the population and intervention. Acronyms for the study name are useful but should not replace descriptive content.<\/li>\n<li>Use the <a href=\"https:\/\/www.editage.com\/blog\/how-to-write-abstract\/#What_Should_Every_Abstract_Include_The_IMRaD_Structure\">structured abstract format<\/a> the journal specifies, usually Introduction, Methods and analysis, Ethics and dissemination, plus the registration number.<\/li>\n<li>Never report pilot data or preliminary findings in the abstract. The abstract of a protocol contains no results by definition.<\/li>\n<\/ul>\n<h3><span class=\"ez-toc-section\" id=\"Administrative_Information\"><\/span>Administrative Information<span class=\"ez-toc-section-end\"><\/span><\/h3>\n<p>These items are unglamorous and are checked first. Missing entries are a common cause of a manuscript being returned before review.<\/p>\n<ul>\n<li>Registry name and unique identifier, with the registration date.<\/li>\n<li>Protocol version number and date, matching the version the ethics committee approved.<\/li>\n<li>Funding source, grant number, and an explicit statement of the funder role in design, conduct, analysis, and the decision to publish.<\/li>\n<li>Sponsor name and contact details.<\/li>\n<li>Roles and responsibilities: coordinating center, steering committee, DMC, and any trial oversight groups.<\/li>\n<li>Current recruitment status and expected start and end dates.<\/li>\n<\/ul>\n<h3><span class=\"ez-toc-section\" id=\"Introduction\"><\/span>Introduction<span class=\"ez-toc-section-end\"><\/span><\/h3>\n<p>Keep your <a href=\"https:\/\/www.editage.com\/blog\/introduction-research-paper\/\">introduction section<\/a> to 600-900 words across 4 moves: what is known, what is uncertain, why that uncertainty matters clinically or scientifically, and what this study will do about it.<\/p>\n<ul>\n<li>Ground the <a href=\"https:\/\/www.editage.com\/blog\/ai-literature-search-how-to-use-ai-for-searching-evaluating-and-synthesizing-research\/#5_Types_of_Research_Gaps\">evidence gap<\/a> in a <a href=\"https:\/\/www.editage.com\/blog\/conducting-and-reporting-systematic-reviews\/\">systematic review<\/a> where one exists. If no review exists, say so; if the review is outdated, say when it was last updated.<\/li>\n<li>Justify the <a href=\"https:\/\/www.editage.com\/blog\/what-is-the-pico-framework-in-research-definition-uses-examples\/#Worked_example_rescuing_an_unfillable_C\">choice of comparator<\/a> Reviewers challenge placebo comparators where an effective standard treatment exists.<\/li>\n<li>State objectives as a short, ordered list, distinguishing primary from secondary, and make each one measurable.<\/li>\n<li>State <a href=\"https:\/\/researcher.life\/blog\/article\/how-to-write-a-research-hypothesis-definition-types-examples\/\">hypotheses<\/a> and the framework: <a href=\"https:\/\/www.editage.com\/blog\/randomized-controlled-trial-rct\/#Superiority_Non-Inferiority_and_Equivalence_Trials\">superiority, non-inferiority, or equivalence<\/a>. Non-inferiority requires a justified margin, stated here and defended in the analysis section.<\/li>\n<li>Explain why the study is feasible now: available population, funding secured, infrastructure in place.<\/li>\n<\/ul>\n<h3><span class=\"ez-toc-section\" id=\"Methods_Design_Setting_and_Participants\"><\/span>Methods: Design, Setting, and Participants<span class=\"ez-toc-section-end\"><\/span><\/h3>\n<ul>\n<li>Name the design precisely, including allocation ratio, framework, and any adaptive features: &#8220;a 2-arm, parallel-group, 1:1 randomized superiority trial.&#8221;<\/li>\n<li>Describe the setting in terms readers can generalize from: country, level of care, number of sites, urban or rural, public or private.<\/li>\n<li>List eligibility criteria as separate inclusion and exclusion bullets, each independently checkable and each justified where non-obvious.<\/li>\n<li>Avoid criteria that cannot be verified at screening, such as &#8220;willing to comply with all study procedures.&#8221;<\/li>\n<li>State who will assess eligibility and obtain consent, and what training they will receive.<\/li>\n<\/ul>\n<h3><span class=\"ez-toc-section\" id=\"Methods_Interventions_and_Comparators\"><\/span>Methods: Interventions and Comparators<span class=\"ez-toc-section-end\"><\/span><\/h3>\n<p>SPIRIT 2025 places extra weight here, and TIDieR provides the operational template. The test is whether an independent team could deliver your intervention exactly as you intend.<\/p>\n<table width=\"624\">\n<thead>\n<tr>\n<td width=\"173\"><strong>TIDieR Element<\/strong><\/td>\n<td width=\"451\"><strong>What to Specify<\/strong><\/td>\n<\/tr>\n<\/thead>\n<tbody>\n<tr>\n<td width=\"173\">Name and rationale<\/td>\n<td width=\"451\">The intervention name and the theory or mechanism by which it is expected to work.<\/td>\n<\/tr>\n<tr>\n<td width=\"173\">Materials and procedures<\/td>\n<td width=\"451\">Physical materials, manuals, software, and the sequence of activities involved.<\/td>\n<\/tr>\n<tr>\n<td width=\"173\">Provider<\/td>\n<td width=\"451\">Who delivers it, their profession, and their training and expertise.<\/td>\n<\/tr>\n<tr>\n<td width=\"173\">Mode of delivery<\/td>\n<td width=\"451\">Individual or group, in person or remote, synchronous or asynchronous.<\/td>\n<\/tr>\n<tr>\n<td width=\"173\">Location<\/td>\n<td width=\"451\">Where delivery occurs, including any infrastructure requirements.<\/td>\n<\/tr>\n<tr>\n<td width=\"173\">Dose and schedule<\/td>\n<td width=\"451\">Number, frequency, duration, and intensity of sessions or doses.<\/td>\n<\/tr>\n<tr>\n<td width=\"173\">Tailoring and modification<\/td>\n<td width=\"451\">Whether the intervention is personalized, and under what rules it may be changed.<\/td>\n<\/tr>\n<tr>\n<td width=\"173\">Adherence and fidelity<\/td>\n<td width=\"451\">How adherence will be measured, and what fidelity checks are planned.<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<p>&nbsp;<\/p>\n<ul>\n<li>Describe the comparator with the same level of detail. Vaguely specified &#8220;usual care&#8221; arms are a persistent reviewer complaint.<\/li>\n<li>State what concomitant care is permitted, prohibited, or recorded.<\/li>\n<li>Give criteria for discontinuing or modifying the intervention for an individual participant, and clarify that discontinuation does not mean withdrawal from follow-up.<\/li>\n<li>Describe strategies to improve adherence: reminders, incentives, session logs, or supervision.<\/li>\n<\/ul>\n<h3><span class=\"ez-toc-section\" id=\"Methods_Outcomes_and_Participant_Timeline\"><\/span>Methods: Outcomes and Participant Timeline<span class=\"ez-toc-section-end\"><\/span><\/h3>\n<p>A fully specified outcome has 5 components. Reviewers check for all of them, and a missing component is one of the fastest ways to attract a major revision.<\/p>\n<table width=\"624\">\n<thead>\n<tr>\n<td width=\"173\"><strong>Component<\/strong><\/td>\n<td width=\"451\"><strong>Worked Example<\/strong><\/td>\n<\/tr>\n<\/thead>\n<tbody>\n<tr>\n<td width=\"173\">Domain<\/td>\n<td width=\"451\">Depressive symptoms<\/td>\n<\/tr>\n<tr>\n<td width=\"173\">Specific measurement<\/td>\n<td width=\"451\">PHQ-9 total score<\/td>\n<\/tr>\n<tr>\n<td width=\"173\">Metric<\/td>\n<td width=\"451\">Change from baseline<\/td>\n<\/tr>\n<tr>\n<td width=\"173\">Method of aggregation<\/td>\n<td width=\"451\">Difference in group means<\/td>\n<\/tr>\n<tr>\n<td width=\"173\">Timepoint<\/td>\n<td width=\"451\">12 weeks after randomization<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<p>&nbsp;<\/p>\n<ul>\n<li>Designate exactly 1 primary outcome. Multiple primary outcomes require a stated multiplicity control strategy.<\/li>\n<li>Justify the choice of measure: validation in your population, minimal clinically important difference, and relevance to patients.<\/li>\n<li>List secondary outcomes and label exploratory outcomes as exploratory in both the protocol and the registry.<\/li>\n<li>Include a schedule of enrollment, interventions, and assessments as a figure. This is a required SPIRIT element and reviewers look for it.<\/li>\n<li>Specify the permitted visit windows, for example 12 weeks plus or minus 7 days, so that protocol deviations are definable.<\/li>\n<\/ul>\n<h3><span class=\"ez-toc-section\" id=\"How_Do_You_Justify_a_Sample_Size\"><\/span>How Do You Justify a Sample Size?<span class=\"ez-toc-section-end\"><\/span><\/h3>\n<p>State the smallest effect worth detecting, every assumption behind the calculation, and the source of each assumption. A number without traceable inputs will not survive review.<\/p>\n<ul>\n<li>Report the target difference and why it is clinically meaningful, not merely the difference reported in a prior study.<\/li>\n<li>Report the assumed control-group event rate or outcome standard deviation, with its source cited.<\/li>\n<li>Report alpha, power, and whether the test is 1-sided or 2-sided, plus any interim analysis adjustment.<\/li>\n<li>Report the anticipated attrition rate and the resulting inflated target, with the attrition assumption justified from comparable studies.<\/li>\n<li>Report the intracluster correlation coefficient and cluster sizes for cluster-randomized designs, and the correlation structure for repeated measures.<\/li>\n<li>Name the software and version used, so the calculation is reproducible.<\/li>\n<\/ul>\n<p>Non-quantitative designs still require a defended sample. Qualitative protocols should state an anticipated sample range, the <a href=\"https:\/\/researcher.life\/blog\/article\/what-are-sampling-methods-techniques-types-and-examples\/\">sampling strategy<\/a>, and the criterion by which sufficiency of data will be judged. Systematic reviews do not need a sample size, but should state a minimum number of studies below which <a href=\"https:\/\/www.editage.com\/blog\/meta-analysis\/\">meta-analysis<\/a> will not be attempted.<\/p>\n<h3><span class=\"ez-toc-section\" id=\"Methods_Allocation_Blinding_and_Bias_Control\"><\/span>Methods: Allocation, Blinding, and Bias Control<span class=\"ez-toc-section-end\"><\/span><\/h3>\n<ul>\n<li>Sequence generation: the method, for example computer-generated permuted blocks, with block sizes and any stratification factors named.<\/li>\n<li>Allocation concealment: the physical or electronic mechanism, for example central web randomization or sequentially numbered opaque sealed envelopes.<\/li>\n<li>Implementation: who generates the sequence, who enrolls participants, and who assigns them. These should not all be the same person.<\/li>\n<li>Blinding: state who is blinded among participants, providers, outcome assessors, and analysts, and how blinding is maintained.<\/li>\n<li>Unblinding: the circumstances permitting emergency unblinding and the procedure for it.<\/li>\n<li>If blinding is impossible, say so plainly and describe what compensates for it, such as objective outcomes or blinded outcome adjudication.<\/li>\n<\/ul>\n<h3><span class=\"ez-toc-section\" id=\"Methods_Data_Collection_and_Management\"><\/span>Methods: Data Collection and Management<span class=\"ez-toc-section-end\"><\/span><\/h3>\n<ul>\n<li>Name the instruments and cite their validation; append the CRFs as supplementary material or state where they can be obtained.<\/li>\n<li>Describe who collects data, their training, and how inter-rater reliability will be assessed where relevant.<\/li>\n<li>Specify the retention strategy: reminders, flexible scheduling, reimbursement, and how participants lost to follow-up will be pursued.<\/li>\n<li>Describe the data management system, including entry method, range and consistency checks, double entry where used, and audit trails.<\/li>\n<li>State where data will be stored, for how long, under what security controls, and who holds access.<\/li>\n<li>Describe de-identification and the point in the workflow at which identifiers are separated from research data.<\/li>\n<\/ul>\n<h3><span class=\"ez-toc-section\" id=\"Methods_Statistical_Analysis_Plan\"><\/span>Methods: Statistical Analysis Plan<span class=\"ez-toc-section-end\"><\/span><\/h3>\n<p>The manuscript carries a condensed analysis section; the full SAP is a separate, versioned document, finalized and dated before any unblinded data are examined.<\/p>\n<table width=\"624\">\n<thead>\n<tr>\n<td width=\"147\"><strong>SAP Element<\/strong><\/td>\n<td width=\"477\"><strong>What Must Be Prespecified<\/strong><\/td>\n<\/tr>\n<\/thead>\n<tbody>\n<tr>\n<td width=\"147\">Analysis populations<\/td>\n<td width=\"477\">Definitions of intention-to-treat, modified intention-to-treat, and per-protocol sets, with the rules for assigning participants to each.<\/td>\n<\/tr>\n<tr>\n<td width=\"147\">Estimand<\/td>\n<td width=\"477\">Population, endpoint, treatment condition, handling of intercurrent events, and the population-level summary measure.<\/td>\n<\/tr>\n<tr>\n<td width=\"147\">Primary analysis<\/td>\n<td width=\"477\">The exact statistical model, the covariates to be adjusted for, and the justification for each covariate.<\/td>\n<\/tr>\n<tr>\n<td width=\"147\">Missing data<\/td>\n<td width=\"477\">The assumed missingness mechanism, the primary approach such as multiple imputation, and the sensitivity analyses.<\/td>\n<\/tr>\n<tr>\n<td width=\"147\">Subgroups<\/td>\n<td width=\"477\">The specific subgroups, the interaction tests to be used, and an acknowledgment that these are <a href=\"https:\/\/www.editage.com\/blog\/how-to-write-a-research-hypothesis-examples-formulation-thesis-research-papers\/\">hypothesis-generating<\/a>.<\/td>\n<\/tr>\n<tr>\n<td width=\"147\">Multiplicity<\/td>\n<td width=\"477\">The adjustment procedure or the explicit decision not to adjust, with reasoning.<\/td>\n<\/tr>\n<tr>\n<td width=\"147\">Interim analyses<\/td>\n<td width=\"477\">Timing, the stopping boundary such as O\u2019Brien-Fleming, and who reviews the results.<\/td>\n<\/tr>\n<tr>\n<td width=\"147\">Sensitivity analyses<\/td>\n<td width=\"477\">Each planned deviation from the primary model and the assumption it is testing.<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<p>&nbsp;<\/p>\n<h3><span class=\"ez-toc-section\" id=\"Methods_Harms_Safety_and_Monitoring\"><\/span>Methods: Harms, Safety, and Monitoring<span class=\"ez-toc-section-end\"><\/span><\/h3>\n<ul>\n<li>Define adverse event, serious adverse event, and any study-specific events of interest, using standard definitions where they exist.<\/li>\n<li>Describe how harms will be elicited: spontaneous report, systematic checklist, or both. SPIRIT 2025 puts additional emphasis on this.<\/li>\n<li>Specify the reporting pathway and timelines to the sponsor, ethics committee, and regulator.<\/li>\n<li>Describe the composition, independence, and charter of the DMC, or state clearly why no DMC is needed.<\/li>\n<li>State the stopping rules for the study as a whole, distinct from individual discontinuation criteria.<\/li>\n<li>Describe planned auditing and monitoring, including frequency, scope, and independence from the investigators.<\/li>\n<li>State the provisions for post-trial care and for compensation in the event of study-related harm.<\/li>\n<\/ul>\n<h3><span class=\"ez-toc-section\" id=\"Ethics_and_Dissemination\"><\/span>Ethics and Dissemination<span class=\"ez-toc-section-end\"><\/span><\/h3>\n<ul>\n<li>Ethics approval: committee name, reference number, and approval date, plus the plan for communicating amendments.<\/li>\n<li>Consent: who takes it, where, how much time participants are given, and the arrangements for participants unable to consent for themselves.<\/li>\n<li>Confidentiality: how personal data are protected before, during, and after the study.<\/li>\n<li><a href=\"https:\/\/www.editage.com\/blog\/what-are-conflicts-of-interest-in-research-meaning-types-examples-and-how-to-write-a-declaration-for-journals\/\">Declaration of interests<\/a> for the sponsor and for the investigators.<\/li>\n<li>Access to data: who has access to the final dataset, and any contractual limits on investigator access.<\/li>\n<li>Open science and data sharing: what will be shared, in what form, when, with whom, and under what conditions. SPIRIT 2025 makes this a distinct section rather than an afterthought.<\/li>\n<li>Patient and public involvement: how patients and the public contributed to design, and how they will be involved in conduct and reporting. Where there was no involvement, say so.<\/li>\n<li>Dissemination: target journals, conferences, plain-language <a href=\"https:\/\/www.editage.com\/blog\/how-to-write-a-research-paper-summary\/\">summaries<\/a>, and how participants will be informed about the results.<\/li>\n<\/ul>\n<h3><span class=\"ez-toc-section\" id=\"Discussion\"><\/span>Discussion<span class=\"ez-toc-section-end\"><\/span><\/h3>\n<p>A protocol discussion is short, typically 300-500 words, and contains no findings. Its job is to argue that the design is the right one and to preempt the obvious objections.<\/p>\n<ul>\n<li>Explain the key design trade-offs and why the chosen option was preferred.<\/li>\n<li>Name the anticipated limitations honestly, including those you have chosen to accept.<\/li>\n<li>Describe the expected contribution: what will be knowable after this study that is not knowable now.<\/li>\n<li>State the trial status at submission, for example &#8220;recruitment began in March 2026 and is ongoing.&#8221;<\/li>\n<li>Do not speculate about the direction of results, and do not include any preliminary data.<\/li>\n<\/ul>\n<h2><span class=\"ez-toc-section\" id=\"Supporting_Documents_That_Travel_With_the_Protocol\"><\/span>Supporting Documents That Travel With the Protocol<span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p>Journals differ on what they require at submission, but assembling the full set early is worth the effort because ethics committees and sponsors will want them regardless.<\/p>\n<table width=\"624\">\n<thead>\n<tr>\n<td width=\"160\"><strong>Document<\/strong><\/td>\n<td width=\"253\"><strong>Purpose<\/strong><\/td>\n<td width=\"211\"><strong>Usually Required at Submission?<\/strong><\/td>\n<\/tr>\n<\/thead>\n<tbody>\n<tr>\n<td width=\"160\">Completed reporting checklist<\/td>\n<td width=\"253\">Demonstrates coverage of every guideline item, with page numbers<\/td>\n<td width=\"211\">Yes, at almost all protocol journals<\/td>\n<\/tr>\n<tr>\n<td width=\"160\">Statistical analysis plan<\/td>\n<td width=\"253\">Full prespecification of every planned analysis<\/td>\n<td width=\"211\">Often optional as a supplement, increasingly expected<\/td>\n<\/tr>\n<tr>\n<td width=\"160\">SPIRIT schedule figure<\/td>\n<td width=\"253\">Visual timeline of enrollment, interventions, and assessments<\/td>\n<td width=\"211\">Yes for trials<\/td>\n<\/tr>\n<tr>\n<td width=\"160\">Informed consent form<\/td>\n<td width=\"253\">Evidence that consent language matches the protocol<\/td>\n<td width=\"211\">Frequently, as a supplementary file<\/td>\n<\/tr>\n<tr>\n<td width=\"160\">Case report forms<\/td>\n<td width=\"253\">Shows exactly what data will be captured<\/td>\n<td width=\"211\">Sometimes, usually as a supplement<\/td>\n<\/tr>\n<tr>\n<td width=\"160\">Data management plan<\/td>\n<td width=\"253\">Storage, security, quality control, and retention<\/td>\n<td width=\"211\">Rarely required, often requested by funders<\/td>\n<\/tr>\n<tr>\n<td width=\"160\">Ethics approval letter<\/td>\n<td width=\"253\">Confirms the study is approved to proceed<\/td>\n<td width=\"211\">Frequently, and always for verification<\/td>\n<\/tr>\n<tr>\n<td width=\"160\">Logic model or flow diagram<\/td>\n<td width=\"253\">Clarifies the causal pathway or participant flow<\/td>\n<td width=\"211\">Optional but persuasive<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<p>&nbsp;<\/p>\n<h2><span class=\"ez-toc-section\" id=\"Where_Should_You_Publish_a_Study_Protocol\"><\/span>Where Should You Publish a Study Protocol?<span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p>Choose a journal that formally lists protocols as an accepted article type. The main options are Trials, BMJ Open, JMIR Research Protocols, BMC series titles, Systematic Reviews, PLOS ONE, and F1000Research.<\/p>\n<p>Submitting a protocol to a journal that does not have a protocol article type wastes weeks and ends in a desk rejection. Check the author instructions for the phrase &#8220;study protocol&#8221; before doing anything else. Note also that most protocol-friendly journals are fully open access, so an APC is the norm rather than the exception.<\/p>\n<table width=\"624\">\n<thead>\n<tr>\n<td width=\"127\"><strong>Journal<\/strong><\/td>\n<td width=\"173\"><strong>Scope<\/strong><\/td>\n<td width=\"100\"><strong>Access Model<\/strong><\/td>\n<td width=\"224\"><strong>Notes<\/strong><\/td>\n<\/tr>\n<\/thead>\n<tbody>\n<tr>\n<td width=\"127\">Trials<\/td>\n<td width=\"173\">Randomized trial protocols across all specialties<\/td>\n<td width=\"100\">Open access<\/td>\n<td width=\"224\">The established home for trial protocols. Strong SPIRIT enforcement.<\/td>\n<\/tr>\n<tr>\n<td width=\"127\">BMJ Open<\/td>\n<td width=\"173\">Protocols across all designs, clinical and health services<\/td>\n<td width=\"100\">Open access<\/td>\n<td width=\"224\">High visibility and a broad readership. Requires ethics approval and registration.<\/td>\n<\/tr>\n<tr>\n<td width=\"127\">JMIR Research Protocols<\/td>\n<td width=\"173\">Digital health, but also protocols and grant proposals generally<\/td>\n<td width=\"100\">Open access<\/td>\n<td width=\"224\">Fast turnaround; accepts a wide range of designs including unfunded work.<\/td>\n<\/tr>\n<tr>\n<td width=\"127\">BMC series titles<\/td>\n<td width=\"173\">Specialty-matched protocols, for example BMC Public Health<\/td>\n<td width=\"100\">Open access<\/td>\n<td width=\"224\">Useful when specialty readership matters more than general visibility.<\/td>\n<\/tr>\n<tr>\n<td width=\"127\">Systematic Reviews<\/td>\n<td width=\"173\">Systematic review and meta-analysis protocols<\/td>\n<td width=\"100\">Open access<\/td>\n<td width=\"224\">Expects PRISMA-P and PROSPERO registration.<\/td>\n<\/tr>\n<tr>\n<td width=\"127\">Pilot and Feasibility Studies<\/td>\n<td width=\"173\">Pilot and feasibility protocols<\/td>\n<td width=\"100\">Open access<\/td>\n<td width=\"224\">Requires prespecified, numeric progression criteria.<\/td>\n<\/tr>\n<tr>\n<td width=\"127\">PLOS ONE<\/td>\n<td width=\"173\">Study protocols across disciplines<\/td>\n<td width=\"100\">Open access<\/td>\n<td width=\"224\">Assesses methodological soundness rather than novelty.<\/td>\n<\/tr>\n<tr>\n<td width=\"127\">F1000Research<\/td>\n<td width=\"173\">Protocols across all designs<\/td>\n<td width=\"100\">Open access<\/td>\n<td width=\"224\">Immediate publication followed by open, named, post-publication peer review.<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<p>&nbsp;<\/p>\n<p>Fees and policies change. Verify current article processing charges, waiver eligibility, and any institutional or national agreements directly on the publisher site before you commit.<\/p>\n<h3><span class=\"ez-toc-section\" id=\"Registered_Reports_as_an_Alternative_Route\"><\/span>Registered Reports as an Alternative Route<span class=\"ez-toc-section-end\"><\/span><\/h3>\n<p>A Registered Report is peer reviewed on methods alone, before data collection. If the methods pass, the journal grants in-principle acceptance and commits to publishing the results whatever they show.<\/p>\n<ul>\n<li>The strength: publication becomes independent of whether the finding is positive, which removes a major source of publication bias.<\/li>\n<li>The cost: review is slower and more demanding, and the design is effectively frozen once accepted.<\/li>\n<li>The constraint: fewer journals offer the format, and availability is concentrated in psychology, neuroscience, and some clinical fields.<\/li>\n<li>The overlap: a Registered Report replaces the separate protocol paper rather than supplementing it.<\/li>\n<\/ul>\n<h3><span class=\"ez-toc-section\" id=\"Free_Alternatives_Worth_Considering\"><\/span>Free Alternatives Worth Considering<span class=\"ez-toc-section-end\"><\/span><\/h3>\n<ul>\n<li>Preprint servers such as medRxiv and OSF Preprints give a citable DOI and a timestamp at no cost, usually within a week.<\/li>\n<li>OSF Registries provides a permanent, time-stamped registration for designs that clinical registries will not accept.<\/li>\n<li>Institutional repositories offer permanence and are often the easiest route for unfunded student research.<\/li>\n<li>Funder-hosted protocol libraries, where they exist, satisfy transparency expectations without an APC.<\/li>\n<\/ul>\n<p>A preprint plus a registry entry delivers most of the transparency and priority benefit of a published protocol. What it does not deliver is peer review of your methods, which is often the main reason to publish in the first place.<\/p>\n<h2><span class=\"ez-toc-section\" id=\"Preparing_the_Submission\"><\/span>Preparing the Submission<span class=\"ez-toc-section-end\"><\/span><\/h2>\n<h3><span class=\"ez-toc-section\" id=\"The_Cover_Letter\"><\/span>The Cover Letter<span class=\"ez-toc-section-end\"><\/span><\/h3>\n<p>Keep it under 350 words and use it to preempt the standard reasons protocols are returned before review.<\/p>\n<ul>\n<li>State the article type explicitly: &#8220;We submit this study protocol for consideration as a Protocol article.&#8221;<\/li>\n<li>Give the registry name, identifier, and registration date in the first paragraph.<\/li>\n<li>Give the ethics committee name, reference number, and approval date.<\/li>\n<li>State the current recruitment status plainly, including the date recruitment began if it has.<\/li>\n<li>Say in 2 sentences why the question matters and why this journal is the right venue.<\/li>\n<li>Confirm the manuscript is not under consideration elsewhere and that all authors have approved it.<\/li>\n<\/ul>\n<h3><span class=\"ez-toc-section\" id=\"What_Do_Editors_Check_First\"><\/span>What Do Editors Check First?<span class=\"ez-toc-section-end\"><\/span><\/h3>\n<p>Editors screen for compliance before they consider science: registration, ethics, recruitment status, checklist, and version details. Failing any of these usually means a return without review.<\/p>\n<table width=\"624\">\n<thead>\n<tr>\n<td width=\"160\"><strong>Element<\/strong><\/td>\n<td width=\"464\"><strong>What Editors Look For<\/strong><\/td>\n<\/tr>\n<\/thead>\n<tbody>\n<tr>\n<td width=\"160\">Registration<\/td>\n<td width=\"464\">A valid identifier, dated before enrollment, with a public record that matches the manuscript.<\/td>\n<\/tr>\n<tr>\n<td width=\"160\">Ethics approval<\/td>\n<td width=\"464\">Named committee, reference number, and date, or a documented exemption.<\/td>\n<\/tr>\n<tr>\n<td width=\"160\">Recruitment status<\/td>\n<td width=\"464\">Ongoing or not yet started. Completed recruitment usually disqualifies the submission.<\/td>\n<\/tr>\n<tr>\n<td width=\"160\">Reporting checklist<\/td>\n<td width=\"464\">Uploaded, completed, with page numbers rather than ticks.<\/td>\n<\/tr>\n<tr>\n<td width=\"160\">Protocol version<\/td>\n<td width=\"464\">A version number and date that matches the approved document.<\/td>\n<\/tr>\n<tr>\n<td width=\"160\">Outcome consistency<\/td>\n<td width=\"464\">The primary outcome in the manuscript, the abstract, and the registry must be identical.<\/td>\n<\/tr>\n<tr>\n<td width=\"160\">Author declarations<\/td>\n<td width=\"464\">Contributions, competing interests, funding, and the funder role.<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<p>&nbsp;<\/p>\n<h2><span class=\"ez-toc-section\" id=\"Why_Do_Protocol_Manuscripts_Get_Rejected\"><\/span>Why Do Protocol Manuscripts Get Rejected?<span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p>Most rejections trace to 5 recurring problems: recruitment already closed, a vague primary outcome, a weakly justified sample size, thin analysis detail, and inadequate bias control.<\/p>\n<table width=\"624\">\n<thead>\n<tr>\n<td width=\"193\"><strong>Common Critique<\/strong><\/td>\n<td width=\"431\"><strong>How to Preempt It<\/strong><\/td>\n<\/tr>\n<\/thead>\n<tbody>\n<tr>\n<td width=\"193\">Recruitment is already complete<\/td>\n<td width=\"431\">Submit before or during recruitment. If recruitment has started, state the date openly and explain the timeline.<\/td>\n<\/tr>\n<tr>\n<td width=\"193\">The primary outcome is vague or plural<\/td>\n<td width=\"431\">Specify all 5 outcome components for a single primary outcome, and match them exactly to the registry.<\/td>\n<\/tr>\n<tr>\n<td width=\"193\">The sample size is not defensible<\/td>\n<td width=\"431\">Show every input, cite the source of each assumption, and justify the target difference clinically.<\/td>\n<\/tr>\n<tr>\n<td width=\"193\">The analysis section is too thin<\/td>\n<td width=\"431\">Name the model, the covariates, the analysis populations, and the missing data strategy; append a full SAP.<\/td>\n<\/tr>\n<tr>\n<td width=\"193\">Bias is not adequately controlled<\/td>\n<td width=\"431\">Detail sequence generation, concealment, blinding, and what compensates where blinding is impossible.<\/td>\n<\/tr>\n<tr>\n<td width=\"193\">The intervention cannot be replicated<\/td>\n<td width=\"431\">Apply TIDieR item by item and describe the comparator with equal rigor.<\/td>\n<\/tr>\n<tr>\n<td width=\"193\">The study adds nothing new<\/td>\n<td width=\"431\">Anchor the gap in a current systematic review and state explicitly what remains unresolved.<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<p>&nbsp;<\/p>\n<h3><span class=\"ez-toc-section\" id=\"Writing_the_Point-by-Point_Response\"><\/span>Writing the Point-by-Point Response<span class=\"ez-toc-section-end\"><\/span><\/h3>\n<p>Make note of the following when <a href=\"https:\/\/www.editage.com\/blog\/respond-to-reviewer-comments\/\">responding to reviewer comments<\/a> on your protocol:<\/p>\n<ul>\n<li>Reproduce each comment in full, then respond immediately beneath it. Do not summarize or merge comments.<\/li>\n<li>Quote the revised text and give its new page and line numbers so reviewers can verify without searching.<\/li>\n<li>Where you <a href=\"https:\/\/www.editage.com\/blog\/respond-to-reviewer-comments\/#Is_it_okay_to_disagree_with_a_peer_reviewer\">disagree<\/a>, say so respectfully and give a reasoned, referenced justification. Reviewers accept well-argued disagreement more often than authors expect.<\/li>\n<li>Where a change would require re-approval by the ethics committee, say so and state your plan.<\/li>\n<li>Submit a clean version and a tracked-changes version unless the journal says otherwise.<\/li>\n<li>Thank reviewers once at the top; repeated thanks in every response add length without value.<\/li>\n<\/ul>\n<h3><span class=\"ez-toc-section\" id=\"Handling_a_Desk_Rejection\"><\/span>Handling a Desk Rejection<span class=\"ez-toc-section-end\"><\/span><\/h3>\n<p><a href=\"https:\/\/www.editage.com\/blog\/desk-rejection-reasons-next-steps-and-how-to-avoid-rejection-without-peer-review\/\">Desk rejections<\/a> on protocols are usually about fit or compliance, not quality, so the fastest recovery is to fix the compliance issue and reformat for a journal whose scope matches.<\/p>\n<ul>\n<li>Read the rejection for the actual reason: scope, article type, missing registration, or recruitment status.<\/li>\n<li>Reformat for the next journal properly, including its reference style, structured abstract headings, and word limits.<\/li>\n<li>Update the recruitment status, because it will have moved on since the first submission.<\/li>\n<li>Do not submit to 2 journals simultaneously; this is a publication ethics violation.<\/li>\n<\/ul>\n<h2><span class=\"ez-toc-section\" id=\"After_Publication\"><\/span>After Publication<span class=\"ez-toc-section-end\"><\/span><\/h2>\n<h3><span class=\"ez-toc-section\" id=\"Amendments_and_Version_Control\"><\/span>Amendments and Version Control<span class=\"ez-toc-section-end\"><\/span><\/h3>\n<p>Studies change. What matters is that changes are documented, dated, approved, and visible, rather than discovered later by a reader comparing the protocol with the results.<\/p>\n<ul>\n<li>Number and date every version, and keep a change log recording what changed, when, and why.<\/li>\n<li>Route substantive amendments through the ethics committee before implementing them.<\/li>\n<li>Update the registry record for any change to eligibility, outcomes, sample size, or analysis, because registries retain and display the full history.<\/li>\n<li>Notify the journal of major amendments; some publish a linked protocol update or correction.<\/li>\n<li>Consider a separate published amendment paper only when the design has changed enough that the original no longer describes the study, such as a substantial change in the primary outcome or population.<\/li>\n<\/ul>\n<h3><span class=\"ez-toc-section\" id=\"Linking_Protocol_Registry_and_Results\"><\/span>Linking Protocol, Registry, and Results<span class=\"ez-toc-section-end\"><\/span><\/h3>\n<ul>\n<li>Cite the published protocol in the <a href=\"https:\/\/www.editage.com\/blog\/methods-section-research-paper\/\">methods section<\/a> of the results paper and compress the methods accordingly.<\/li>\n<li>Add the protocol DOI to the registry record so the 3 objects point at each other.<\/li>\n<li>Report every deviation from the protocol in the results paper, with the reason and the date it occurred.<\/li>\n<li>Distinguish clearly between prespecified and post hoc analyses in the results paper. This is the payoff for publishing the protocol at all.<\/li>\n<li>Use a consistent study acronym across all outputs so the family of publications is findable.<\/li>\n<\/ul>\n<h3><span class=\"ez-toc-section\" id=\"Dissemination\"><\/span>Dissemination<span class=\"ez-toc-section-end\"><\/span><\/h3>\n<ul>\n<li>Write a plain-language summary of the protocol for participants, patient groups, and sites.<\/li>\n<li>Share the protocol with recruiting sites as an onboarding document; it reduces variation in delivery.<\/li>\n<li>Deposit the accepted version in your institutional repository if the license allows.<\/li>\n<li>Track citations, since protocol citations often reveal the systematic reviews that will eventually include your results.<\/li>\n<\/ul>\n<h2><span class=\"ez-toc-section\" id=\"Toolkit_Timelines_Targets_and_Checklists\"><\/span>Toolkit: Timelines, Targets, and Checklists<span class=\"ez-toc-section-end\"><\/span><\/h2>\n<h3><span class=\"ez-toc-section\" id=\"How_Long_Does_the_Whole_Process_Take\"><\/span>How Long Does the Whole Process Take?<span class=\"ez-toc-section-end\"><\/span><\/h3>\n<p>Plan for 6-12 months from the first protocol draft to a published protocol paper. Ethics review and journal peer review are the 2 phases that most often overrun.<\/p>\n<table width=\"624\">\n<thead>\n<tr>\n<td width=\"173\"><strong>Phase<\/strong><\/td>\n<td width=\"127\"><strong>Typical Duration<\/strong><\/td>\n<td width=\"324\"><strong>Notes<\/strong><\/td>\n<\/tr>\n<\/thead>\n<tbody>\n<tr>\n<td width=\"173\">Drafting the master protocol<\/td>\n<td width=\"127\">4-10 weeks<\/td>\n<td width=\"324\">Longer for multi-site or regulated studies. Circulate a skeleton early to surface disagreement.<\/td>\n<\/tr>\n<tr>\n<td width=\"173\">Internal and sponsor review<\/td>\n<td width=\"127\">2-4 weeks<\/td>\n<td width=\"324\">Run in parallel with statistical review of the SAP.<\/td>\n<\/tr>\n<tr>\n<td width=\"173\">Ethics submission and approval<\/td>\n<td width=\"127\">4-12 weeks<\/td>\n<td width=\"324\">Assume at least 1 round of revisions. Multi-site approvals take longer.<\/td>\n<\/tr>\n<tr>\n<td width=\"173\">Registration<\/td>\n<td width=\"127\">1-3 weeks<\/td>\n<td width=\"324\">Registry curators frequently return records for clarification.<\/td>\n<\/tr>\n<tr>\n<td width=\"173\">Adapting to a manuscript<\/td>\n<td width=\"127\">2-3 weeks<\/td>\n<td width=\"324\">Mostly editorial if the master protocol is complete.<\/td>\n<\/tr>\n<tr>\n<td width=\"173\">Peer review to first decision<\/td>\n<td width=\"127\">4-10 weeks<\/td>\n<td width=\"324\">Varies widely by journal.<\/td>\n<\/tr>\n<tr>\n<td width=\"173\">Revision and acceptance<\/td>\n<td width=\"127\">3-8 weeks<\/td>\n<td width=\"324\">Usually 1 or 2 rounds for protocols.<\/td>\n<\/tr>\n<tr>\n<td width=\"173\">Production to publication<\/td>\n<td width=\"127\">2-5 weeks<\/td>\n<td width=\"324\">Faster at fully open access journals.<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<p>&nbsp;<\/p>\n<h3><span class=\"ez-toc-section\" id=\"How_Long_Should_Each_Section_Be\"><\/span>How Long Should Each Section Be?<span class=\"ez-toc-section-end\"><\/span><\/h3>\n<p>A typical protocol manuscript runs 3,500-5,000 words excluding references. Use the following as a starting allocation and check the journal limit before drafting.<\/p>\n<table width=\"624\">\n<thead>\n<tr>\n<td width=\"200\"><strong>Section<\/strong><\/td>\n<td width=\"113\"><strong>Target Words<\/strong><\/td>\n<td width=\"311\"><strong>Notes<\/strong><\/td>\n<\/tr>\n<\/thead>\n<tbody>\n<tr>\n<td width=\"200\">Abstract<\/td>\n<td width=\"113\">250-350<\/td>\n<td width=\"311\">Structured, with the registration number included.<\/td>\n<\/tr>\n<tr>\n<td width=\"200\">Introduction<\/td>\n<td width=\"113\">600-900<\/td>\n<td width=\"311\"><a href=\"https:\/\/www.editage.com\/blog\/how-to-write-the-background-of-a-research-paper-examples-and-tips\/\">Background<\/a>, gap, <a href=\"https:\/\/www.editage.com\/blog\/how-to-write-research-objectives-examples-and-tips-for-students-and-dissertations\/\">objectives<\/a>, <a href=\"https:\/\/www.editage.com\/blog\/how-to-write-a-research-hypothesis-examples-formulation-thesis-research-papers\/\">hypotheses<\/a>.<\/td>\n<\/tr>\n<tr>\n<td width=\"200\">Design and setting<\/td>\n<td width=\"113\">250-400<\/td>\n<td width=\"311\">Include the precise design label.<\/td>\n<\/tr>\n<tr>\n<td width=\"200\">Participants and eligibility<\/td>\n<td width=\"113\">300-450<\/td>\n<td width=\"311\">Inclusion and exclusion as separate lists.<\/td>\n<\/tr>\n<tr>\n<td width=\"200\">Interventions and comparators<\/td>\n<td width=\"113\">500-800<\/td>\n<td width=\"311\">TIDieR-level detail; the most under-written section.<\/td>\n<\/tr>\n<tr>\n<td width=\"200\">Outcomes and timeline<\/td>\n<td width=\"113\">400-600<\/td>\n<td width=\"311\">Plus the schedule figure.<\/td>\n<\/tr>\n<tr>\n<td width=\"200\">Sample size<\/td>\n<td width=\"113\">200-350<\/td>\n<td width=\"311\">Every assumption with its source.<\/td>\n<\/tr>\n<tr>\n<td width=\"200\">Randomization and blinding<\/td>\n<td width=\"113\">250-400<\/td>\n<td width=\"311\">Sequence, concealment, implementation, masking.<\/td>\n<\/tr>\n<tr>\n<td width=\"200\">Data collection and management<\/td>\n<td width=\"113\">300-450<\/td>\n<td width=\"311\">Instruments, training, storage, security.<\/td>\n<\/tr>\n<tr>\n<td width=\"200\">Statistical analysis<\/td>\n<td width=\"113\">400-700<\/td>\n<td width=\"311\">Condensed from the full SAP.<\/td>\n<\/tr>\n<tr>\n<td width=\"200\">Harms and monitoring<\/td>\n<td width=\"113\">250-400<\/td>\n<td width=\"311\">Definitions, reporting pathway, DMC.<\/td>\n<\/tr>\n<tr>\n<td width=\"200\">Ethics and dissemination<\/td>\n<td width=\"113\">400-600<\/td>\n<td width=\"311\">Includes open science and PPI.<\/td>\n<\/tr>\n<tr>\n<td width=\"200\">Discussion<\/td>\n<td width=\"113\">300-500<\/td>\n<td width=\"311\">Trade-offs, limitations, contribution. No results.<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<p>&nbsp;<\/p>\n<h3><span class=\"ez-toc-section\" id=\"Common_Pitfalls\"><\/span>Common Pitfalls<span class=\"ez-toc-section-end\"><\/span><\/h3>\n<table width=\"624\">\n<thead>\n<tr>\n<td width=\"180\"><strong>Pitfall<\/strong><\/td>\n<td width=\"213\"><strong>Why It Matters<\/strong><\/td>\n<td width=\"231\"><strong>Fix<\/strong><\/td>\n<\/tr>\n<\/thead>\n<tbody>\n<tr>\n<td width=\"180\">Outcome differs between protocol and registry<\/td>\n<td width=\"213\">Reads as outcome switching and undermines the whole point of publishing<\/td>\n<td width=\"231\">Reconcile both records before submission and after every amendment<\/td>\n<\/tr>\n<tr>\n<td width=\"180\">Writing in the past tense<\/td>\n<td width=\"213\">Signals that the study is already done<\/td>\n<td width=\"231\">Draft methods in the future tense throughout<\/td>\n<\/tr>\n<tr>\n<td width=\"180\">Including pilot results<\/td>\n<td width=\"213\">Protocols report no findings by definition<\/td>\n<td width=\"231\">Move pilot data to the introduction as cited prior work<\/td>\n<\/tr>\n<tr>\n<td width=\"180\">Undefined usual care comparator<\/td>\n<td width=\"213\">Makes the effect estimate uninterpretable<\/td>\n<td width=\"231\">Describe the comparator with TIDieR-level detail<\/td>\n<\/tr>\n<tr>\n<td width=\"180\">Sample size with no cited assumptions<\/td>\n<td width=\"213\">The single most common statistical criticism<\/td>\n<td width=\"231\">Cite a source for every input and name the software<\/td>\n<\/tr>\n<tr>\n<td width=\"180\">No missing data strategy<\/td>\n<td width=\"213\">Attrition is certain; silence about it is not credible<\/td>\n<td width=\"231\">Prespecify the primary approach and sensitivity analyses<\/td>\n<\/tr>\n<tr>\n<td width=\"180\">Silence on patient and public involvement<\/td>\n<td width=\"213\">Now an explicit SPIRIT 2025 item<\/td>\n<td width=\"231\">Describe involvement, or state that there was none and why<\/td>\n<\/tr>\n<tr>\n<td width=\"180\">Vague data sharing statement<\/td>\n<td width=\"213\">Fails open science requirements at most journals<\/td>\n<td width=\"231\">Specify what, when, to whom, and under what conditions<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<p>&nbsp;<\/p>\n<h3><span class=\"ez-toc-section\" id=\"Pre-Submission_Checklist\"><\/span>Pre-Submission Checklist<span class=\"ez-toc-section-end\"><\/span><\/h3>\n<table width=\"624\">\n<thead>\n<tr>\n<td width=\"491\"><strong>Check<\/strong><\/td>\n<td width=\"133\"><strong>Confirmed<\/strong><\/td>\n<\/tr>\n<\/thead>\n<tbody>\n<tr>\n<td width=\"491\">Registered prospectively, with identifier and date in the manuscript<\/td>\n<td width=\"133\"><\/td>\n<\/tr>\n<tr>\n<td width=\"491\">Ethics approval obtained, with committee name, reference, and date<\/td>\n<td width=\"133\"><\/td>\n<\/tr>\n<tr>\n<td width=\"491\">Recruitment not yet complete, and status stated openly<\/td>\n<td width=\"133\"><\/td>\n<\/tr>\n<tr>\n<td width=\"491\">Correct reporting guideline identified and checklist completed with page numbers<\/td>\n<td width=\"133\"><\/td>\n<\/tr>\n<tr>\n<td width=\"491\">Exactly 1 primary outcome, fully specified across all 5 components<\/td>\n<td width=\"133\"><\/td>\n<\/tr>\n<tr>\n<td width=\"491\">Primary outcome identical in manuscript, abstract, and registry<\/td>\n<td width=\"133\"><\/td>\n<\/tr>\n<tr>\n<td width=\"491\">Sample size inputs all cited, with software named<\/td>\n<td width=\"133\"><\/td>\n<\/tr>\n<tr>\n<td width=\"491\">Randomization, concealment, and blinding fully described<\/td>\n<td width=\"133\"><\/td>\n<\/tr>\n<tr>\n<td width=\"491\">SAP finalized, versioned, and dated<\/td>\n<td width=\"133\"><\/td>\n<\/tr>\n<tr>\n<td width=\"491\">Schedule of enrollment, interventions, and assessments included as a figure<\/td>\n<td width=\"133\"><\/td>\n<\/tr>\n<tr>\n<td width=\"491\">Harms definitions and reporting pathway specified<\/td>\n<td width=\"133\"><\/td>\n<\/tr>\n<tr>\n<td width=\"491\">Data sharing and open science statement complete<\/td>\n<td width=\"133\"><\/td>\n<\/tr>\n<tr>\n<td width=\"491\">PPI statement included<\/td>\n<td width=\"133\"><\/td>\n<\/tr>\n<tr>\n<td width=\"491\">Protocol version number and date stated<\/td>\n<td width=\"133\"><\/td>\n<\/tr>\n<tr>\n<td width=\"491\">All methods written in the future tense<\/td>\n<td width=\"133\"><\/td>\n<\/tr>\n<tr>\n<td width=\"491\">No results, pilot data, or speculation about findings anywhere in the text<\/td>\n<td width=\"133\"><\/td>\n<\/tr>\n<tr>\n<td width=\"491\">Author contributions, competing interests, and funder role declared<\/td>\n<td width=\"133\"><\/td>\n<\/tr>\n<tr>\n<td width=\"491\">Journal word limit, reference style, and abstract structure followed<\/td>\n<td width=\"133\"><\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<p>&nbsp;<\/p>\n<h2><span class=\"ez-toc-section\" id=\"Key_Resources\"><\/span>Key Resources<span class=\"ez-toc-section-end\"><\/span><\/h2>\n<ul>\n<li>EQUATOR Network reporting guideline library: equator-network.org<\/li>\n<li><a href=\"https:\/\/www.equator-network.org\/reporting-guidelines\/spirit-2013-statement-defining-standard-protocol-items-for-clinical-trials\/\">SPIRIT 2025 statement<\/a> and explanation and elaboration document, published across BMJ, JAMA, Lancet, Nature Medicine, and PLOS Medicine in April 2025<\/li>\n<li><a href=\"https:\/\/www.equator-network.org\/wp-content\/uploads\/2014\/03\/TIDieR-Checklist-PDF.pdf\">TIDieR checklist<\/a> for intervention description<\/li>\n<li><a href=\"https:\/\/www.prisma-statement.org\/protocols\">PRISMA-P<\/a> for systematic review protocols, with PROSPERO for registration<\/li>\n<li>ICMJE Recommendations, covering authorship criteria and the prospective registration requirement<\/li>\n<li>Directory of Open Access Journals and COPE, for verifying journal legitimacy<\/li>\n<li>Open Science Framework, for free registration, preprints, and protocol deposit<\/li>\n<\/ul>\n<h2><span class=\"ez-toc-section\" id=\"Frequently_Asked_Questions\"><\/span>Frequently Asked Questions<span class=\"ez-toc-section-end\"><\/span><\/h2>\n<h3><span class=\"ez-toc-section\" id=\"What_Is_the_Difference_Between_a_Study_Protocol_and_a_Research_Proposal\"><\/span>What Is the Difference Between a Study Protocol and a Research Proposal?<span class=\"ez-toc-section-end\"><\/span><\/h3>\n<p>A research proposal is written to persuade a funder that a study deserves support; it emphasizes significance, innovation, team credibility, and budget. A protocol is written to specify execution, and its value lies in operational precision: exact eligibility criteria, exact outcome definitions, exact randomization mechanics, and exact analysis models. The background sections overlap and can be reused. The methods sections should not be, because a proposal that would satisfy a funder will usually be judged incomplete by an ethics committee or a protocol reviewer.<\/p>\n<h3><span class=\"ez-toc-section\" id=\"Can_You_Publish_a_Study_Protocol_After_Data_Collection_Has_Started\"><\/span>Can You Publish a Study Protocol After Data Collection Has Started?<span class=\"ez-toc-section-end\"><\/span><\/h3>\n<p>Usually yes, provided recruitment is still ongoing and you state the start date openly. Most protocol journals accept manuscripts submitted during recruitment. What they generally refuse is a protocol submitted after recruitment has closed or after any results are known, because the prospective guarantee that gives a protocol its value no longer holds. Never present a study as not yet started when it has: editors verify this against the registry record, and misrepresentation is a publication ethics issue rather than a formatting one.<\/p>\n<h3><span class=\"ez-toc-section\" id=\"Is_a_Published_Study_Protocol_Counted_as_a_Peer-Reviewed_Publication\"><\/span>Is a Published Study Protocol Counted as a Peer-Reviewed Publication?<span class=\"ez-toc-section-end\"><\/span><\/h3>\n<p>Yes. Protocols in journals such as Trials, BMJ Open, and BMC titles undergo external peer review, receive a DOI, are indexed in PubMed, and are citable. They count as peer-reviewed publications for most academic purposes. Some appointment and promotion committees weight them below original research articles, and some institutions score them separately, so it is worth checking local rules. A registry record or a preprint, by contrast, is not peer reviewed and should not be presented as though it were.<\/p>\n<h3><span class=\"ez-toc-section\" id=\"How_Much_Does_It_Cost_to_Publish_a_Study_Protocol\"><\/span>How Much Does It Cost to Publish a Study Protocol?<span class=\"ez-toc-section-end\"><\/span><\/h3>\n<p>Most protocol journals are fully open access, so an APC applies and typically runs into 4 figures in US dollars. Costs vary substantially by publisher and change regularly, so check the current figure on the publisher site rather than relying on secondhand numbers. Also consult your university librarian if the APC is out of budget as they can suggest several options to reduce or eliminate the fee: institutional read-and-publish agreements, national open access deals, publisher waiver programs for low-income and middle-income countries, and hardship waivers. Free alternatives include preprint servers, OSF Registries, and institutional repositories.<\/p>\n<h3><span class=\"ez-toc-section\" id=\"Do_You_Need_Ethics_Approval_Before_Publishing_a_Study_Protocol\"><\/span>Do You Need Ethics Approval Before Publishing a Study Protocol?<span class=\"ez-toc-section-end\"><\/span><\/h3>\n<p>For studies involving human participants, essentially always. Journals require the approving committee name, the reference number, and the approval date, and many ask to see the approval letter. Studies genuinely exempt from review, such as some analyses of fully anonymized public datasets, still need documentation of that exemption from the relevant committee. Submitting a protocol while approval is merely pending is a common cause of delay: editors will hold or return the manuscript until the confirmation arrives, so it is faster to wait.<\/p>\n<h3><span class=\"ez-toc-section\" id=\"How_Long_Should_a_Study_Protocol_Paper_Be\"><\/span>How Long Should a Study Protocol Paper Be?<span class=\"ez-toc-section-end\"><\/span><\/h3>\n<p>Most published protocol manuscripts run 3,500-5,000 words excluding references, abstract, and tables, with methods occupying roughly 60-70% of that. Journal limits differ, and some impose none while still expecting concision. The full master protocol is a separate document and is commonly 40-90 pages. Length is not the quality signal reviewers respond to: a 4,000-word protocol that fully specifies its outcomes, sample size, and analysis will be received far better than a 7,000-word one that does not.<\/p>\n<h3><span class=\"ez-toc-section\" id=\"Can_You_Publish_a_Protocol_for_a_Systematic_Review_or_Meta-Analysis\"><\/span>Can You Publish a Protocol for a Systematic Review or Meta-Analysis?<span class=\"ez-toc-section-end\"><\/span><\/h3>\n<p>Yes, and it is now close to standard practice. Register the review in PROSPERO before screening begins, write the protocol against the PRISMA-P checklist, and submit to a journal such as Systematic Reviews, BMJ Open, or a specialty title. The protocol should prespecify the search strategy including at least 1 full database search string, eligibility criteria, screening and extraction procedures, the risk of bias tool, and the synthesis approach including how heterogeneity will be assessed and when meta-analysis will not be attempted.<\/p>\n<h3><span class=\"ez-toc-section\" id=\"What_Happens_If_Your_Study_Deviates_From_the_Published_Protocol\"><\/span>What Happens If Your Study Deviates From the Published Protocol?<span class=\"ez-toc-section-end\"><\/span><\/h3>\n<p>Deviations are normal and are not a problem in themselves; concealing them is. Document every deviation with its date and reason, seek ethics approval for substantive changes before implementing them, update the registry record, and report all deviations transparently in the results paper. Reviewers of the results manuscript will compare it against the published protocol, so an unexplained discrepancy in the primary outcome or the analysis plan attracts far more scrutiny than an acknowledged, justified change would have.<\/p>\n","protected":false},"excerpt":{"rendered":"Key Takeaways: A published protocol locks your methods into the public record before any data exist, which protects the study against later accusations of outcome switching and turns months of design work into a citable, peer-reviewed output. SPIRIT 2025 is now the reference standard for randomized trial protocols: 34 minimum items, a new open science [&hellip;]","protected":false},"author":3,"featured_media":1924,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_ayudawp_aiss_exclude":false,"_ayudawp_aiss_summary":"A published protocol locks your methods into the public record before any data exist, which protects the study against later accusations of outcome switching and turns months of design work into a citable, peer-reviewed output. Include the phrase \"study protocol\" or \"protocol for\" so the article type is unambiguous in search results and citations. State the article type explicitly: \"We submit this study protocol for consideration as a Protocol article.\".","_ayudawp_aiss_summary_provider":"extractive","_ayudawp_aiss_summary_hash":"78685455ee1a60a5806b7b3b76f1cbd1da11b1ec"},"categories":[1],"tags":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v20.6 - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>How to Write and Publish a Study Protocol: Meaning, Examples, Format - Educational Articles For Researchers, Students And Authors - Editage Blog<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/www.editage.com\/blog\/how-to-write-and-publish-a-study-protocol-meaning-examples-format\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"How to Write and Publish a Study Protocol: Meaning, Examples, Format - Educational Articles For Researchers, Students And Authors - Editage Blog\" \/>\n<meta property=\"og:description\" content=\"Key Takeaways: A published protocol locks your methods into the public record before any data exist, which protects the study against later accusations of outcome switching and turns months of design work into a citable, peer-reviewed output. 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