Table 5 Different types of databases that will be used in the study
Types of database | Characteristics |
|---|---|
Clinical trial database | will be programmed, tested and validated prior to study start and for every modification during the study if applicable |
Quantitative behavioural/adherence/acceptability database | 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. |
Laboratory databases | 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. |
Qualitative behavioural/adherence/acceptability data | IDI/FGD transcripts and coding |