StudyprotocolCriteriaStudyprotocolarticleswillgenerallyonlybeconsideredforproposedorongoingtrialsthathavenotcompletedparticipantrecruitmentatthetimeofsubmission.Trialsadvisesthatstudyprotocolsaresubmittedwellbeforerecruitmentcompletes,howeverwewillalsoonoccasionconsiderstudyprotocolssubmittedbeforethelastpatient/lastvisit.This,includinganexplanationofwhyitwasnotpossibletosubmitearlier,shouldbeincludedwithinthemanuscripttext.Pleaseconfirmthestatusofyourstudyatsubmission.Pleasenote:From1stJanuary2021,Trialswillnolongerconsiderstudyprotocolsforpilotorfeasibilitytrialsforpublication.Werecommendthatthesemanuscriptsareinsteadsubmittedtooursisterjournal,PilotandFeasibilityStudies.Trialsalsoconsidersstudyprotocolsassessingaspectsofthedesign,conductorreportingofrandomizedtrials.Thesestudiesdonotnecessarilyneedtobetrialsandincludestudiessuchascoreoutcomesetdevelopmentforuseintrialsandprocessevaluationsthatrunalongsidetrials.Pleasefollowtherelevantreportingguidelineforthestudydesignandincludethecorrespondingchecklistasanadditionalfile.TheonlineprotocoltemplatecalledSEPTRE(SPIRITElectronicProtocolTool&Resource)isaweb-basedoptiontocreate,manage,andregisterprotocolsusingtheSPIRITguidance.Allsubmittedprotocolsmusthaveethicalapproval.Ifthestudyhasundergonefullexternalpeerreviewaspartofthefundingprocess,thestudyprotocolwillusuallyonlyundergoeditorialpeerreviewbyaProtocolEditor.Studyprotocolswithoutmajorexternalfundingwillundergofull,externalpeerreview.Studyprotocolswithoutethicalapprovalwillgenerallynotbeconsidered.Tosupportefficienthandlingofyourstudyprotocol,theEditorsadvisethatprospectiveauthorsfamiliarizethemselveswiththisEditorialonwhatisexpectedinastudyprotocolsubmission.AdditionalFilesOnsubmission,thefollowingdocumentationshouldbeuploadedasAdditionalFiles.IftheoriginaldocumentsarenotinEnglish,anEnglishtranslationofeachismandatory.EthicalapprovaldocumentCopyoftheoriginalfundingdocumentationAcompletedSPIRITchecklist(unlessthestructuredstudyprotocoltemplatehasbeenused),...
