Drug Evaluation Committee 2021-20 Movement of medical institution due to subject's 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 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?
Opinion of the Pharmaceutical Cooperative Association
There is no provision in GCP for transferring the site due to the subject's relocation. It depends on the study protocol, such as the continuity of evaluation, but in general, there are no restrictions on transfer to another site. 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 procedures may be 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 New-type Coronavirus Infection (Updated May 26, 2020)" provides Q&A on the administration of investigational new drugs and other drugs and on the evaluation of subjects' case reports at other investigational sites conducting the same clinical trial. 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 investigational site should confirm the subject's intention to continue participating in the clinical trial at the new investigational site, provide medical information necessary for the subject to continue participating in the clinical trial, and keep records related to the subject. The explanation should include the provision of medical information, etc. necessary for continued participation in the clinical trial at the new site and the handover of records pertaining to the subject to the new site. In addition, it is noted that the new site must provide the subject with a written explanation and consent to continue participating in the clinical trial, and that the site must provide the subject with the medical information necessary to continue participating in the clinical trial. 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.