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Clinical trial database
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will be programmed, tested and validated prior to study start and for every modification during the study if applicable
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Quantitative behavioural/adherence/acceptability database
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will be tested prior to use but will not be fully validated according to a clinical trial validation protocol. Revisions to this database after study start could be necessary when the initial qualitative research show that our questionnaires are not optimal.
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Laboratory databases
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will be developed for the laboratory tests done in batches. Data in these databases will be entered and double-checked manually by qualified laboratory professionals according to the study SOP. The data may be combined with variables from the above two databases for analysis.
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Qualitative behavioural/adherence/acceptability data
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IDI/FGD transcripts and coding
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