Drug Evaluation Committee 2009-40 Allowance/denial of participation in the deliberations and voting by the Investigational New Drug Review Committee by a member who is an investigational drug administrator (person in charge)
Related classification: Clinical Trial Review Committee
Initial release date: January 2010
Revised publication date: March 2021
Question
If an assistant investigator is a member of an investigational review board (IRB), can he/she participate in the deliberation and voting of the relevant clinical trial?
Is the IRB member considered to be a "collaborator" of a "committee member related to the investigator" as defined in GCP Article 29, Paragraph 1, Operational Notification 1?
Our SOP states that "members related to the investigator may not participate in the deliberations and voting on the clinical trial.
Opinion of the Pharmaceutical Manufacturers Association of Japan (PMAJ)
As stated in our opinion to question No. ( 2009-16 ), "committee members related to the investigator" under Article 29, Paragraph 1, Guidance 1 of the GCP is understood to be the investigator, subinvestigator, and collaborator. The investigational drug manager is a person who generally performs the following duties (GCP Article 39 Guidance 4), and the assistant investigational drug manager assists the investigational drug manager's duties. We believe that there is no problem if they participate in the deliberation and voting of the clinical trial.
- Receipt of investigational drug from sponsor
- Storage and management of investigational drug
- Dispense the investigational drug to subjects
- Return of unused investigational drug to the sponsor
On the other hand, if the investigator is in charge of a part of the tasks that are beyond the scope of investigational drug management and are performed by a subinvestigator or a collaborator (see GCP Article 2 Guidance 8 and Article 43.1 Guidance 1), he/she cannot participate in the deliberation and voting of the relevant clinical trial.
Regarding the scope of "members related to the relevant clinical trial may not participate in the deliberation and voting" stipulated in your hospital's SOP, it would be desirable to follow GCP Article 29 and specify in the SOP any additional scope or requirements that your hospital deems necessary.
GCP Article 2 Guidance 8
The "investigator collaborator" in Paragraph 18 is a member of the team conducting the clinical trial at the site, who is guided and supervised by the investigator and cooperates in the work of the investigator and subinvestigator from a professional standpoint.
GCP Article 43.1 Guidance 1
When the investigator assigns a part of important tasks related to the clinical trialto a subinvestigator or a collaborator, the investigator shall ... (omitted) obtain the approval of the subinvestigator or collaborator.
Reason for revision of opinion
With the issuance of the GCP Guidance (No. 0831-15 issued on August 31, 2020 by the Pharmaceutical Affairs Agency of Japan), minor changes have been made to the descriptions.