Collection of documents related to the status of the clinical trial
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Study initiation package
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Study initiation package including: •Registration number of the clinical study in a registry meeting WHO Registry criteria •Final version of study protocol as approved by the regulator(s) / ethics committee(s)•Regulatory and ethics (if applicable, institutional) approvals required for the enrolment of the first study participant
Report on the status of posting results for the screening people with DM for TB
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Summary results posted in the applicable registry/ies
Population impact
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Population Impact of LTBI screening for DM
Midterm recruitment report
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The report includes an overview of the number of recruited participants by clinical sites, any problems in recruitment and, if applicable, a detailed description of implemented and planned measures to compensate for any incurred delays.
Annual consortium meetings 1
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Plan and hold annual consortium meeting
Performance of CAD4TB system
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Evaluation of use of the CAD4TB system for active TB screening
Data sharing policy
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Updated Data sharing policy, which will be updated continuously
Plan for dissemination and exploitation, including publication policy
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Updated plan for dissemination and exploitation including communication activities
TB, HIV and LTBI prevalence in DM
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Prevalence of LTBI, and TB and HIV disease among people with DM