Table 3.

Definitions of data points classified as category I or category II

Category	Definition
Category I	The data were recorded only for the selected trial and could be directly entered into the eCRFs without ensuring consistency with other source data, e.g., data related to participant characteristics, vital signs, blood collection date and time, and ophthalmological tests recorded only for the selected clinical trial
Category II	The data were already recorded in EHR in daily medical practice or generated through the EHR system during the selected trial and could not be directly entered into the eCRFs, e.g., data on medical history, prescriptions for concomitant medications, and clinical laboratory tests measured at the selected clinical trial site

EHR electronic health record, eCRFs electronic case report forms