Work Package 6: Project Management & Administration

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 (significant overlap with WP1)

  • Acquisition and renewal of the ethical and regulatory approvals required to run the trial at all sites.
  • Production and dissemination of all study documentation (e.g. Patient Information Sheets, Work Practice Documents and Data Management Plan).
  • Regular monitoring of all 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

  • Management and control of the project budget locally and across the consortium.
  • Regular communication between LSHTM and each beneficiary to foster a clear, collaborative and supportive approach to financial management.
  • Submission of the annual technical and financial reports to the EDCTP.
  • Administration, logistics, event management and communications.
  • Provision of advice on project-related communications and publication.

       

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