Organisation and Governance
Study Sponsor
The study is sponsored by Imperial College London with responsibilities defined by a written clinical trial agreement with collaborators. PrEPVacc’s collaborators are listed on the Partners page
Trial Steering Committee (TSC)
The role of the TSC is to provide overall supervision for the trial and provide advice through its independent Chair to the TMG and the Sponsor.
The Trial Steering Committee (TSC) has independent members, including the Chair and community representatives as well as selected members of the TMG.
Independent Data Monitoring Committee (IDMC)
An Independent Data Monitoring Committee (IDMC) is the only group who sees the confidential, accumulating data for the trial. Reports to the IDMC will be produced by MRC Clinical Trials Unit (CTU) at UCL statisticians.
The IDMC will meet regularly during the trial and will advise the TSC. The IDMC can recommend premature closure or reporting of the trial, or that recruitment to any research arm be discontinued.
Trial Management Group (TMG)
The TMG is responsible for the day-to-day running and management of the trial and meets approximately once a month usually by teleconference.
It comprises the Coordinating Investigator, other lead investigators (clinical and non-clinical), members of the MRC/UVRI and LSHTM Uganda Research Unit Trial Coordinating Centre and the MRC Clinical Trials Unit (CTU) at UCL, and community contributors.
Executive group to the TMG
The Executive group is responsible for making decisions on the scientific aspects of the trial as well as its communications materials. It comprises a representative of all the applicants (and hence beneficiaries) of the grant submission i.e. those who are most closely involved with the trial, and is led by Imperial College London and MRC/UVRI and LSHTM Uganda Research Unit.
Trial Management Team (TMT)
The Trial Management Team (TMT) comprises those with coordinating operational responsibilities and includes the Chair of the TMG, members of the MRC/UVRI and LSHTM Uganda Research Unit, members of MRC CTU at UCL, Imperial College London, IAVI and EuroVacc.
Trial Safety Group (TSG)
The TSG is responsible for reviewing SAEs, notable events, interruptions and discontinuations.
The Trial Safety Group (TSG) includes medically-qualified staff at MRC/UVRI and LSHTM Uganda Research Unit who are not assessing participants directly, medically qualified staff at MRC CTU at UCL including the Trial Physician, Ludwig Maximilian Unversity, IAVI and EuroVacc (or a medically-qualified delegate), and representatives from the product providers.
Participant and Public Involvement Advisory Groups
Each participating centre has an established Community Advisory Group/Board composed of stakeholders that represent the local community as well as local health care providers and allied organisations.
Prior to implementation, the study design and procedures is discussed with these local groups, questions answered, and their advice sought. This may lead to modifications in the study procedures in order to address any concerns and to facilitate recruitment and retention.
Progress will be reported to each of Community Advisory Group/Board during the study, issues arising will be aired and plans to address these formulated. Before dissemination of the results they will also meet to ensure that the key findings of the study are clear and the impact on the community fully explored.