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The key features of INHALE operational (day-to-day) management, decision-making and project organization are represented as follows:
• Independent Programme Steering Committee
Strategic advice is provided by the independent Programme Steering Committee (PSC). This is responsible for oversight of the study to safeguard the interests of study participants. The PSC includes an independent Chair, a Statistician, a Behavioural Scientist, a Clinical Microbiologist and a representative of the Patient and Public Involvement. The PSC advises the Principal Investigators, Clinical Trial Unit, funder and sponsor on all aspects of the study through its independent Chair.
• Technical Management Committee
Operation is guided by the Technical Management Committee (TMC). This includes Work Package Leaders (WPLs), a Statistical Advisor, a Clinical Advisor and a Trial Co-ordinator. The TMC will help with design, co-ordination and strategic management of the study. It will adapt the scientific activities as necessary to achieve the project's goals.
• Scientific Advisory Panel/Committee
This committee provides advice and independent guidance. It includes experts in all the fields relevant to INHALE (Clinical Microbiology, Molecular Diagnostics, Behavioural Science, Health Economics, and Statistics) and 2 lay members from the Patient and Public Involvement committee.
• Patient and Public Involvement
Patient and public involvement (PPI) panel is an important part of every research project funded by the NHS as it is part of research commissioning and management processes.
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