Conceptual PlanningDesign and PlanningReview cyclesSystems setupSite setup and implementationProtocol and trial documentation developmentEstablishfoundationalknowledgePrepareessentialtrialdocumentsConduct feasibility assessmentStart drafting the CSRInternal assessmentSet up data capture systemBuild randomization systemSet up adjudication systemSite qualification – surveys and pre-study visitsSite-specific budget developmentSet upsite-specific infrastructureSiteinitiationvisitSample sizeSite selectionEndpointsParticipant populationCentral studyteamFundersConduct consultations with key stakeholdersResearch requirements,guidelines,and principlesACTdefinitionand scopeFamiliarization with SPIRITTrial design optionsIND/IDEdefinitionand scopeRandomization and blinding procedureParticipant recruitment strategyStatistical analysis approachRisk assessment and management planMonitoring planData management and sharing planData monitoring and safety planSAPParticipant information sheetCRFsInformed consent formsSOPsIND / IDE submission and reviewObtain site approval and sign contractsEthics boardContractsConduct and operationsSite activation and participant recruitmentOngoing study conduct and monitoringStudy completionData managementSafety evaluationProtocol compliance and deviationsRegulatory reporting and communicationsInternal study activitiesParticipant managementImplement participant recruitment strategyFollow study entry and allocation proceduresOngoing study conduct and monitoringInterim analysisDatabaselockSite close-out activitiesResult disseminationAnalysis and disseminationTrialcompleteDevelop and publish the manuscriptDisseminate results to participantsComplete any secondary dissemination activitiesConduct the prespecified analysis