NIHR RCT Microbiologist
We are putting together the governance for a NIHR RCT involving long-term urinary catheter use and CAUTI. We need to nominate a clinical microbiologist with knowledge and interest in CAUTI, who preferably has some trial experience (not the Old Bailey!) to join the Trial Steering Committee.
They have to be independent, ie not associated with any of our trial centres. The TSC meets annually and has responsibility to oversee the project on behalf of the Project Sponsor and Project Funder (NIHR) and to ensure that the DoH Research Governance Framework for Health and Social Care is adhered to. Day to day running of the project is not the responsibility of the TSC. Nominees have to be approved by NIHR.
The main features of the TSC/SSC are as follows:
• To provide advice, through its Chair, to the Trial/Project Funder, the Trial/Project Sponsor, the Chief Investigator, the Host Institution and the Contractor on all appropriate aspects of the project
• To concentrate on progress of the trial/project, adherence to the protocol, patient safety (where appropriate) and the consideration of new information of relevance to the research question
• The rights, safety and well-being of the participants are the most important considerations and should prevail over the interests of science and society
• To ensure appropriate ethical and other approvals are obtained in line with the project plan
• To agree proposals for substantial protocol amendments and provide advice to the sponsor and funder regarding approvals of such amendments
• To provide advice to the investigators on all aspects of the trial/project.
If anyone is interested in this, please would they contact me to discuss email@example.com