Drug Evaluation Committee 2008-50 Procedures for requesting a clinical trial by an in-country manager for a clinical trial (Part 1)
Related classification: clinical trial contracting procedures
First published: Jul 2009
Revised publication date: December 2021
Question
We are planning to commission an international clinical trial. In that case, is a two-party contract with a clinical research organization (CRO) sufficient?
Also, is there any problem with using the name of the domestic clinical trial manager in the clinical trial request form and other documents?
I heard that there is no problem because the domestic CRO will handle the notification of the clinical trial in Japan, but I am worried because this is my first time. Are there any precautions we should take?
Opinion of the Pharmaceutical Manufacturers Association of Japan (PMAJ)
Article 7, Paragraph 1, Item 1 of the GCP stipulates that "the name (in the case of a corporation, its name, if any) and address (abbreviated) of the party requesting the clinical trial" should be included in the clinical trial protocol. (In the case of a corporation, the name and address of its principal office. (If the person does not have a domicile in Japan, the name and the name and address of the country of domicile of the person and the name and address of the administrator of the clinical trial as prescribed in Article 15. The same shall apply in Article 13, paragraph 1, item 2). The provisions of Article 13, paragraph (1), item (ii) and Article 13, paragraph (1), item (iii) stipulate that The same shall apply in Article 13, Paragraph 1, Item 2. The "name and address of the person requesting the clinical trial" is one of the items to be included in the clinical trial agreement. Therefore, it is necessary to specify the sponsor and the domestic manager of the clinical trial in the clinical trial agreement. In accordance with GCP Article 15 (see below), it is considered acceptable to have a two-party contract between the sponsor and the site.
In addition, according to Article 16, Paragraph 1, Item 2 of GCP, the name and address of the sponsor (or the name and address of the country in which the sponsor resides if the sponsor does not have a domicile in Japan, and the name and address of the in-country caretaker) must be written on the container or package of the investigational drug. However, the GCP does not stipulate how to include this information in the clinical trial request form. However, GCP does not stipulate how to describe them in the clinical trial request form. It is considered acceptable if the procedures of the site are followed, but it is desirable to describe them in a way that clearly distinguishes between the person requesting the clinical trial (the sponsor) and the in-country caretaker of the clinical trial.
In accordance with Article 15, Guidance 2 of the GCP, the domestic manager of a clinical trial is required to submit a notification of the clinical trial plan, and the notification is to be prepared and submitted in accordance with the notice related to the notification of clinical trial. In this case, the information related to the in-country caretaker is to be submitted as "Information on the person notifying the clinical trial", including the type of the person notifying the clinical trial (sponsor or in-country caretaker).
GCP Article 15
(2) A person who does not have an address in Japan and who intends to request a clinical trial shall notify a person who has an address in Japan (including a representative of a foreign corporation having an office in Japan) as a person who can request a clinical trial on behalf of the person who intends to request the clinical trial in order to have the person take measures necessary to prevent the occurrence or spread of health hazards due to the investigational drug. (2) A person who can request a clinical trial on behalf of a person who intends to request a clinical trial shall be appointed from among persons having an address in Japan (including a representative of a foreign corporation having an office in Japan). (2) The Company shall appoint a person from among persons having an address in Japan (including a representative of a foreign corporation having an office in Japan) who is able to make a request for a clinical trial on behalf of a person who intends to make a request for a clinical trial. (2) The investigator shall have the person appointed from among the following persons (including a representative of a foreign corporation having an office in Japan) perform the procedures for the request for a clinical trial.
Reason for revision of opinion
With the issuance of the GCP Guidance (July 30, 2021, Pharmaceutical Affairs Bureau, No. 0730-3), the referenced clause has been changed.