Data collection with an online app
ADVERSE EVENTS
An electronic case report form (eCRF) app was developed (by JK and LG) for online entry (by the attending physicians), randomization, stratification, patient screening, treatment and outcomes data. The eCRF app was hosted on a secure Amazon Web Services (AWS) server accessed by investigators via a user-specific username and password. The app consisted of 5 pages: screening, randomization, treatment, adverse events, and outcome. Instructions for its use (see supplemental appendix) were sent to all participants, and several online training sessions were held, including completion of mock patient data. All users had to be fully proficient before getting permission to enter real patient data. Specific instructions were issued for when the data were to be placed within each of the five pages.The app was written in R Shiny and was hosted on shinyapps.io. Authentication based on user id and password was required to access the app. Data were stored in an AWS Aurora database instance, encrypted both at rest and in transit. It was only accessible via a secure, separately authenticated RestFUL API written in PHP and hosted on an AWS Elastic Compute server. All data entry and modification were audit trailed. The app downloaded and uploaded data to the database via the API securely via the SSL protocol. Data for analysis was also downloaded via the API interface. R version 4.0.3 was used to perform all analyses of data collected in the study. The quality of the data was controlled by JK and all queries were passed on to the individual sites, assisted by the study coordinator based in India.