Principal investigator and research physicians
ADVERSE EVENTS
Design and conduct of the trialPreparation of protocol and revisionsPreparation of case report formsPreparation of materials for international review, board/independent ethics committee applications Patient enrolmentPerforming surgeryPublication of study reportsMembers of Trial Management CommitteeAnnual progress reporting to the funder and ethics committeeSerious adverse events reporting to ethics committee Responsible for trial data fileBudget administrationData verification