End TB Clinical Trial - Output 2

ITM will:
- Serve as reference laboratory for the Trial and be responsible for the storage of Human Biological samples in strict compliance with the Protocol and conduct of mycobacterial analyses of Human Biological Samples in strict compliance with the Protocol;
- Determine necessary TB laboratory set-up and organization to conduct required tests according to the Protocol and GCLP guidelines;
- Ensure ongoing evaluation of adequate set-up and test conduct by Site laboratories according to the Protocol and GCLP guidelines. Inform Sponsor of deficiencies and provide recommendations and support for resolutions of deficiencies;
- Supervise SOPs for site operations related to its responsibilities under the Protocol and the Agreement, but not held responsible for the results obtained at the sites;
- Develop the microbiology manual for the Trial and ensure that the SOPs are followed for all microbiology procedures necessary for the Trial;