Data management, confidentiality, and quality assurance (QA)
CRF
RECRUITMENT, CRF
Operational management of the trial will be aided by an externally validated, custom-built database management software. It will link with the VDSS and be used for recruitment, scheduling, and tracking of participant contacts and outcomes. Primary clinical data will be recorded on validated instances of Redcap (Research Electronic Data Capture) [We will consider any document where demographic, clinical, or laboratory data is first recorded prior to entry into our digital Case Record Forms (CRFs) as source data. This includes hospital records, clinical charts, office charts, pharmacy, and laboratory records. If hospital data is unavailable in electronic format, the study team will maintain scanned copies until the CRFs are verified. If a CRF is the first place where data is entered, it will be considered source data. Hardcopy study documents will be stored securely in a confidential location. To maintain the anonymity of participants, they will only be referred to by their participant ID on study documents, except in informed consent sheets. All data collected during the trial will be stored at the site for at least 3 years after its completion. The PI will have complete access to the final dataset.A dedicated QA team will regularly validate a proportion of the data entered into CRFs and ensure that all trial processes follow the protocol and Good Clinical Practices. The microbiology labs that process blood samples will participate in an external QA programme. The study processes will be reviewed by an external monitoring team at the end of one year.