This Work Package is led by LSHTM as Co-ordinator. It covers important tasks relating to the management of the clinical trial and to the financial and administrative management of the EDCTP grant, as well as management of the project as a whole. A number of valued colleagues at each beneficiary organisation are involved in this Work Package to ensure that the project is delivered in compliance with both ethical and regulatory requirements, and with EDCTP legal and financial regulations.

Clinical Trial Project Management (overlap with WP1)

• Acquisition and renewal of the ethical and regulatory approvals required to run the trial at all sites.
• Production and dissemination of study documentation (e.g. Patient Information Sheets, Work Practice Documents and Data Management Plan).
• Monitoring of all recruiting sites during the trial and at close-out.
• Organisation of the Trial Steering Committee and Data and Safety Monitoring Committee.

Financial and Administrative Project Management

• Project Management.
• Management and control of the project budget.
• Communication between LSHTM and each beneficiary to foster a clear, collaborative and supportive approach to financial management.
• Technical and financial reporting to EDCTP.
• Administration, logistics, event management and communications.