Quality control and quality assurance
MINOR
We do not anticipate any major deviation from the protocol such as any harm to the participant, or enrollment of participants not eligible for the study. Minor deviations like lost to follow-up will be addressed by enrolling an adequate sample size taking into consideration at an attrition level of 5%. We will communicate with the Ethical Review Board, and trial registries if any major and/or minor deviation occurs during the trial. The data monitoring committee will regularly check data and monitor it to maintain the data quality. An expert will double-check the validation of data collected by the data collectors. The data entry team will link records that have been collected with the help of individual identifiers assigned. We will remove this identifying information once the records are done matching. The anonymized data will be uploaded to a central web-based platform regularly, after following all the appropriate confidentiality requirements. We will use an encrypted, password-protected centralized database system to store data, and only authorized members of the research team will be allowed access.