Lost to Follow up A patient will be considered lost to follow-up if he or she repeatedly fails to return for scheduled visits and is unable to be contacted by the study site. The following actions must be taken if a patient fails to return to the clinic for a required study visit: • The site must attempt to contact the patient and reschedule the missed visit as soon as possible and counsel the patient on the importance of maintaining the assigned visit schedule and ascertain whether or not the patient wishes to and/or should continue in the study. • Before a patient is deemed lost to follow-up, the Investigator or designee must make every effort to regain contact with the patient (where possible, 3 telephone calls and, if necessary, a certified letter to the patient’s last known mailing address or local equivalent methods). These contact attempts should be documented in the patient’s medical record. • Should the patient continue to be unreachable, he/she will be considered to have withdrawn from the study. Discontinuation of specific sites or of the study as a whole are handled as part of Section 10.1.8.
