Synexus

The ICF states that subjects will be paid $if they complete all study visits. Staff at the Atlanta site were adding up the amount per visit instead of the total amount stated in the consent of $500. There was a discrepancy in what was in the ICF- the amount per visit and number of
visits didn't total the $500. (There was an internal error that occurred) Therefore subjects were being told the stipend was $instead of what the consent stated. Upon becoming aware of the subject complaint via the study contract research organization, Radiant VP of Operations reached out to the Atlanta site staff to educate them on the correct stipend amounts- that we always follow the ICF- if a subject completes the study they will be paid $500; if they complete certain visits they will be paid for those visits. An in-service was performed the same day with the Atlanta site staff. All vaccine subjects at their next visit were re-educated that they would be paid $if they completed all study visits. The sponsor and contract research organization were also notified. This subject is still on study and will be paid the full amount if they complete all study visits