Utilization of Third-Party Resources Such as Person Locating Services for Collection of Long-Term Follow-Up (LTFU) Data

At times, a sponsor or other entity will establish a Long-Term Follow-Up (LTFU) plan in order to assist in obtaining data about the research participants in a protocol. The LTFU plan is usually described in the protocol and may be limited to one country or conducted across multiple countries. The plan is normally executed by the site, sponsor or CRO research staff, but on occasion they are also executed by third party person/patient locating firms. WCG IRB will review protocols and consent forms that describe LTFU strategies. The plans should describe the person or entity that will be utilized, the confidentiality/privacy protections in place, and how the research staff or locator service will locate participants.

A third-party locator service cannot be used unless the participants have been notified in the consent form(s). If participants have consented to the use of a third-party locator service, then the data that they consent to being collected can be obtained using such a service, in addition to the service of locating participants who have been lost to follow up.

Alternatively, if participants have not or cannot provide consent, the sponsor/investigator can review publicly available records as per their state or local guidelines to collect LTFU data without IRB review.

In addition to utilizing a third-party service, the Investigator may use a third person contact (parent, legal guardian, legally authorized representative, caretaker) to collect LTFU data if a participant provides demographic information for such a person as well as consent to contact them as part of the consent process.