Lead-In Data Collection

Collect Lead-In Data

Role: Data Collector

Activities associated with the lead-in study day (‘Study Event’) should be collected during a subject’s lead-in visit (typically ‘Day -1’). These activities typically round out data required for final eligibility determination and subsequent progression into the treatment stage of the study. Note that lead-in activities are typically untimed, meaning that each activity is not required to be collected at a specific time of day.

Order Safety Labs

Role: Safety Lab Staff

As safety lab specimens are collected, ClinSpark builds an order queue for submission to the reference laboratory. Typically, one order is placed once all samples have been collected for the lead-in visit. Note that if a sample was collected but the corresponding subject was found to be ineligible prior to ordering, that particular sample can either be placed on hold (and therefore not submitted to the reference lab) or submitted to the reference laboratory followed by a request to cancel resulting of the sample.