Data management
Data will be managed by a PhD biostatistician and a data manager. All staff on the study will be trained in proper data management and security. Paper files will be stored in a locked cabinet within a locked room. All digital data will be stored on either secure, password protected institutional servers or in REDCap. Participant tracking will be conducted using custom software on a SQL server. Randomization will be completed in REDCap. REDCap will also be used to record informed consent and HIPAA authorization when completed electronically.