Trial Management Tool

AboutPre-trial proceduresResearch questionProtocol developmentPublishing the protocolPrepare trial schematicSponsorship and governance arrangementsResearch governance and good clinical practiceSponsorshipApprove final trial documentationTrial registrationB Set-up phaseSelect the trial teamSelecting the trial teamTrial competanciesHow to recruit staffTraining issuesGuidance on good clinical practiceProblems with recruitment and retention of staff How to deal with failures to recruit staff or a slow recruitment processHow to deal with staff leaving and how to avoid problems when key staff leaveSet-up the coordinating centreOrganise the trial structureRisk assessmentSetting up data management systemsData management systemsMethods of data collectionSetting up recruitment proceduresHow are the participants to be identified?Recruitment - is the participant eligibility?Recruitment logisticsSetting up the randomisation proceduresSetting up the intervention proceduresDocumenting proceduresCollaborator trial recruitmentCollaborator recruitmentStandardisation across sitesPlanning for disaster recoveryStatistical analysisC Active phaseSafety monitoring and adverse event reportingData and safety monitoringAdverse event reporting requirementsManagement and monitoringProgress reportingRetentionParticipantsCollaborating centresParticipant and centre withdrawalOngoing recruitmentProtocol amendmentsBudget managementData entryQuality controlStatisticsCompliance and missing dataInterim analysisStatistical programmingScheduling and organising the DMC meetingsHealth economicsCostsEconomic evaluationMeasurement of benefitsD Close downMethod of trial closureReporting, dissemination and notification of resultsPublication policyNotifying participants of study findingsFinal reportData analysisDissemination of resultsStakeholdersArchivingClosure on capital items such as buildings, equipment, vehicles