Drug Evaluation Committee 2021-20 Transfer of an Investigator Site Due to a Subject’s Relocation
Related Category: Other
Initial Publication Date: August 2021
Revised Publication Date: March 2024
Question
A subject currently participating in a clinical trial is moving out of the prefecture, making it difficult to continue visiting the current Investigator Site. The subject wishes to continue
participating in
the clinical trial.
If the same clinical trial is being conducted at a facility within commuting distance of the subject’s new residence, is it possible for the subject to continue participating in the trial at that other Investigator Site?
The sponsor believes this would be possible if approved by the IRB, but is this acceptable under GCP?
JPMA Opinion
GCP does not contain specific provisions regarding a change in the Investigator Site due to a subject’s relocation. While details such as the continuity of evaluation depend on the clinical trial protocol, as a general rule, there are no restrictions on transferring to another Investigator Site.
Regarding
the continuation of the clinical trial, the handling of investigational drugs currently being used by the subject, and case report forms, procedures may be specified in the sponsor’s SOP; therefore, please confirm this with the sponsor.
Additionally, the “Q&A Regarding the Conduct of Clinical Trials for Drugs, Medical Devices, and Regenerative Medicine Products Under the Impact of COVID-19(Updated May 26, 2020)” includes Q&As regarding situations where a subject receives administration of the investigational drug or undergoes evaluations specified in the clinical trial protocol at a different Investigator Site conducting the same trial. While stating that, in principle, it is appropriate for a clinical trial to be conducted and completed at a single medical institution capable of conducting the trial independently,the original Investigator Site must confirm with the subject their intention to continue participating in the trial at the receiving Investigator Site, provide the medical information necessary for continued participation, and transfer the subject’s records to the receiving Investigator Site.Furthermore, it is noted that the receiving Investigator Site must provide the subject with a written explanation regarding the continuation and conduct of the clinical trial and obtain written informed consent, while also receiving the medical information and other data necessary for the subject’s continued participation from the original Investigator Site.Although these are Q&As regarding the conduct of clinical trials under the impact of COVID-19, we recommend referring to them.