Drug Evaluation Committee 2023-51 Administration of Investigational Drugs at Affiliated Clinics
Related Category: Outsourcing of Operations
Initial Publication Date: March 2024
Question
Due to inconvenient transportation to the Investigator Site, we are currently considering whether it would be possible to treat affiliated clinics as home-visit nursing stations or similar entities and administer investigational drugs at those clinics.If these affiliated clinics are treated as home-visit nursing stations, etc., would there be any issues with us managing them as an SMO?If this is possible, we would appreciate your guidance on any precautions we should take in such cases.
Opinion of the JPMA
The administration of investigational drugs at medical institutions, such as affiliated clinics, constitutes a clinical trial activity. Therefore, when administering investigational drugs at a medical institution, we believe it is necessary to file a clinical trial notification as an Investigator Site and to enter into a clinical trial contract with the sponsor based on Article 13 of the Good Clinical Practice (GCP) guidelines.Furthermore, according to the Report of the Study Group on the Formulation of Standard Guidelines for the Use of SMOs (November Heisei 14, Ministry of Health, Labor and Welfare), tasks that are legally restricted under the Medical Care Act, the Worker Dispatch Act, and other laws are considered tasks that SMOs cannot perform.Since Article 15-3 of the Medical Care Act does not explicitly list the administration of pharmaceuticals as a task that medical institutions may outsource, we believe that medical institutions cannot outsource this task to an external party.