Data management
CRF
CRF
Clinical data will be entered into a study-specific database by trained designated study staff on a regular basis from completed Case Record Forms (CRF) using Redcap. Information will primarily be captured using Redcap and CRFs will be printed out for filing and storage. Case Record Forms and other source documents will be kept in locked cabinets. No participant-identifying information will be disclosed in any publication or at any conference activities arising from the study. The participant data captured in the Redcap tool will be accessed in real time by the data manager, who will provide data queries for the study team to address. In addition, the Redcap data collection tool has been fashioned to generate automated checks on entry of certain variables that are out of range. Data management procedures are detailed in the standard operating manual.