Lead-In Subject Management

Safety Assessments

Role: PI

Safety assessments occur regularly throughout a trial and facilitate investigator oversight and interpretation of collected data in a common location for ease of access. Typical PI safety assessments include the assignment of significance and/or normality to out of range vitals or ECG measurements. Laboratory results may also be reviewed via the assessment workflow, although results are typically reviewed by way of the Study > Lab Data Module.

Eligibility Assessment

Role: PI

After all lead-in data has been collected and all investigator assessments have been completed and lab results reviewed, eligibility determination can be completed for each subject. This includes the review of automated eligibility checks which are applicable at lead-in; followed by an assignment of eligibility status. Eligibility status following lead-in will dictate which subjects are eligible to dose, pending final pre-dose activities.