Drug Evaluation Committee 2021-20 Movement of Investigator Site due to Subjects' Relocation
Related classification: Other
Initial release date: Aug. 2021
Revised release date: Mar 2024
Question.
A subject participating in a clinical trial has moved out of the prefecture and is unable to visit the Investigator Site. The subject is willing to continue the clinical trial.
If the same clinical trial is being conducted at a facility that is accessible from the new location, is it possible for the subject to continue participating in the clinical trial at the other facility?
The sponsor is of the opinion that this is possible if approved by the IRB, but is this a problem under GCP?
JPMA's opinion
There are no provisions in the GCP regarding the transfer of Investigator Site due to the subject's relocation. It depends on the study protocol, such as continuity of evaluation, but in general, transfer to another Investigator Site is not restricted. Please confirm with the sponsor regarding the continuation of the clinical trial, handling of investigational drugs currently being used by the subject, and handling of case report forms, etc., as there may be procedures stipulated in the sponsor's SOPs.
In addition, "Q&A on Conducting Clinical Trials of Drugs, Medical Devices, and Regenerative Medicine Products under the Influence of a New Type of Coronavirus Infection (Updated May 26, 2020)" provides Q&A on the administration of investigational drugs, etc. and evaluations prescribed in the study protocol at another Investigator Site where the same clinical trial is being conducted. The Q&As are provided for when a subject undergoes administration of an investigational drug, etc. or an evaluation prescribed in the protocol at another investigational site conducting the same clinical trial. In principle, it is appropriate for a clinical trial to be conducted and completed at a medical institution that can conduct the clinical trial independently, and the original Investigator Site should confirm the subject's intention to continue participating in the clinical trial at the new Investigator Site, and provide the subject with the medical information and records necessary for the subject to continue participating in the clinical trial. The subject's medical information and records related to the subject shall be handed over to the Investigator Site at the new hospital. Furthermore, the Investigator Site to which the subject is to be transferred must provide the subject with a written explanation and written consent to continue participating in the clinical trial, and must receive the medical information necessary for the subject to continue participating in the clinical trial from the original Investigator Site. Although this is a Q&A regarding the implementation of clinical trials under the influence of novel coronavirus infection, we recommend that you refer to it.