Comprehensive scientific, clinical, strategic and organisational management

Comprehensive oversight to the project includes the convening of all project management structures: - Project Coordination Committee - Project Advisory Committee - Project Ethics Committee - Scientific Steering Committee - Trail Management Group This process will be led by ITM but all beneficaries will be involved and certain support mechanisms (such as the PAC and SSC) will have independent, non-beneficary actors, including the represenation of national interests from the study site (Ministry of Health, Red Cross, etc.) The mechanisms of and interaction between these platforms will be well described and agree upon within any additional agreements pertaining to this study (Consortium agreement, trail agreements, Ministerial agreements, etc.) All elements pertaining to the comprehensive management of the study will be fully reported on in periodic technical reports pertaining to Grant Agreement regulations. Any issues arising outside of the reporting period will be covered in ad hoc reporting to the Commission. All minutes of meetings of committees will be kept for inspection or submission by or to the Commission, as required.