Drug Evaluation Committee 2012-37 Investigational drug management, biospecimen processing and storage using facilities of affiliated medical institutions
Related classification: Other
First published: December 2012
Revised publication date: March 2021
Question
There are two medical institutions under the same management, as follows.
- Hospital A (mainly for inpatients)
- Clinic A (mainly outpatient clinic)
Clinic A will conduct the clinical trial, but will outsource the management of the investigational drug and the processing (centrifugation and freezing) of blood specimens to Hospital A. Instead of simply renting the facilities of Hospital A, the dispensing of the investigational drug, storage and management of the investigational drug will be performed by the pharmacist (investigational drug manager and assistant investigational drug manager) of Hospital A, and specimen processing will be performed by Hospital A staff.
Question 1
Is the following the only procedure we need to follow with the site?
- The management of investigational new drugs at Hospital A is specified in the investigational new drug management procedure at Clinic A.
- A contract of outsourcing is concluded between Clinic A and Hospital A (stipulating management of investigational drugs, processing of blood specimens, record keeping, direct inspection, etc.).
- The Clinical Trial Review Committee at Clinic A will review the above system.
- The clinical trial contract is a bilateral contract between the sponsor and Clinic A. Hospital A is not included in the contractor.
Question 2
Should the scope of work of Hospital A be described in the "Others" section of Clinic A?
Opinion of the Pharmaceutical Manufacturers Association of Japan (PMAJ)
Question 1
Under the Medical Care Act, pharmaceutical dispensing services performed by pharmacists cannot be outsourced. In addition, Article 39 Guidance 2 of the GCP states that a pharmacist, physician or dentist at the site must be appointed as an investigational drug manager and that the investigational drug must be managed under the management and responsibility of the investigational drug manager. Therefore, it is not possible to entrust the management of investigational drugs to Hospital A. Therefore, it is necessary to appoint an investigational drug manager in Clinic A.
There is no problem if Clinic A and Hospital A conclude an agreement regarding the outsourcing of blood sample processing and storage, and it is not necessary to obtain the opinion of the Clinical Trial Review Committee.
Question 2
In the "Handling of Notification of a Clinical Trial Plan for a Drug by a Person Who Wants to Request a Clinical Trial," issued on August 31, 2020 by the Director, Drug Evaluation and Management Division, Pharmaceuticals and Consumer Health Bureau, Ministry of Health, Labour and Welfare (No. 0831-10), the following items are stated in the notification of a clinical trial plan.
- Name, address, and scope of contracted services of a party (site management organization (SMO), etc.) that is contracted by a medical institution to perform part of the services related to the conduct of a clinical trial.
Consignment of processing and storage of blood specimens does not fall under the above-mentioned consignment, and therefore, it is not necessary to be stated in the clinical trial plan notification.
Reason for revision of opinion
In accordance with the August 31, 2020 issuance of Pharmaceutical Affairs and Pharmaceutical Affairs Bureau, Ministry of Health, Labour and Welfare, Drug Evaluation and Management Division Director Notification No. 0831-10, "Handling of Notification of a Clinical Trial Plan for a Drug by a Person Who Wants to Request a Clinical Trial," minor changes were made to the description of the clinical trial plan notification.