Lost to Follow-up. A study patient will be considered lost to follow-up if the patient repeatedly fails to return for scheduled visits and is unable to be contacted by the study site. The Investigator should make all efforts to contact the patient and to determine the patient’s health status, including at least her vital status (in accordance with applicable regulations related to privacy and confidentiality). A patient should not be considered lost to follow-up until due diligence has been completed and documented. 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. • In cases in which the 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 Should the patient continue to be unreachable, he/she will be considered to have withdrawn from the study with a primary reason of lost to follow-up.
Lost to Follow-up. A participant 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 participant fails to return to the clinic for a required study visit: • The site must attempt to contact the participant and reschedule the missed visit as soon as possible and counsel the participant on the importance of maintaining the assigned visit schedule and ascertain whether or not the participant wishes to and/or should continue in the study. • Before a participant is deemed lost to follow-up, the Investigator or designee must make every effort to regain contact with the participant (where possible, 3 telephone calls and, if necessary, a certified letter to the participant’s last known mailing address or local equivalent methods). These contact attempts should be documented in the participant’s medical record. • Should the participant continue to be unreachable, he/she will be considered to have withdrawn from the study.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.
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 explain to the patient the importance of maintaining the assigned visit schedule and ascertain whether 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 documented telephone calls 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 be lost to follow-up, and this will be documented in the patient medical record. • Any patient who does not withdraw from the study but who stops attending study visits and does not respond to 3 documented contact attempts will be considered lost to follow- up.
Lost to Follow-up. A subject will be considered lost to follow-up if he or she repeatedly fails to engage for scheduled visits and is unable to be contacted by the study site. The following actions must be taken if a subject fails to return to the clinic for a required study visit: • The site will attempt to contact the subject and reschedule the missed visit. The site will then counsel the subject on the importance of maintaining the assigned visit schedule. • Before a subject is deemed lost to follow-up, the investigator or designee will make every effort to regain contact with the subject (where possible, 3 telephone calls and, if necessary, a certified letter to the subject’s last known mailing address or local equivalent methods). These contact attempts should be documented in the subject’s medical record or study file. • If all attempts to contact the subject fail, he or she will be considered to have withdrawn from the study with a primary reason of lost to follow-up.
Lost to Follow-up. Should a subject fail to attend a required study visit, the site should attempt to contact the subject and reschedule the missed visit as soon as possible. The site should also counsel the subject on the importance of maintaining the assigned visit schedule and ascertain whether or not the subject wishes to and/or should continue in the study based on previous noncompliance. In cases where the subject does not return for the rescheduled visit or cannot be reached to reschedule the missed visit, the site should make every effort to regain contact with the subject so that they can appropriately be withdrawn from the study with a primary reason of “Lost to Follow-up”, including at least three documented attempts to contact the subject (ie, phone, email, or certified letter). Efforts to establish the possible reason for discontinuation should be documented.
Lost to Follow-up. The subject stopped coming for visits and study personnel were unable to contact the subject • Withdrawal of consent: The subject desired to withdraw from further participation in the study in the absence of an investigator-determined medical need to withdraw. If the subject gave a reason for withdrawing, it should be recorded in the CRF. • Adverse Event (Adverse Reaction): Clinical events occurred that in the medical judgment of the investigator for the best interest of the subject are grounds for discontinuation. This includes serious and nonserious adverse events regardless of relation to study medication.
Lost to Follow-up. A patient will be considered lost to follow-up if he/she unable to be contacted by the study site.
