Drug Evaluation Committee 2008-17 Scope of External Committee Members - "Persons with No Conflict of Interest with the Investigator Site" (Part 2)
Related classification: Clinical Trial Review Committee
Date of first publication: January 2009
Question
I would like to ask you about the interests of external committee members in a clinical trial review committee.
This medical institution is a hospital affiliated with a certain company. An employee of the parent company serves as an external member of the clinical trial review committee of this medical institution.
Article 28, Paragraph 1, Item 4 of the GCP states that "a person who does not have an interest in the Investigator Site shall be added among the committee members. The medical institution is of the opinion that since the organization is separate, there is no problem with having this staff member as an external committee member.
JPMA's Opinion
As you pointed out, Article 28, Paragraph 1, Item 4 of the GCP stipulates that "Among the committee members, those who do not have any interest in the Investigator Site must be included. Explanation of this provision is provided in Article 28, Paragraph 1, Guidance 5 of the GCP, but it does not mention cases such as the one you are asking about. However, if the external committee member (an employee of the parent company of the Investigator Site) is not involved in the business of the Investigator Site, he or she is considered to be a "person who does not have an interest in the Investigator Site. However, if such a committee member is in a position that could strongly influence the operations of the Investigator Site, such as being an officer or manager of the parent company, or is in a position that could be strongly influenced by the occurrence of a problem at the company that established the Investigator Site, he/she would be considered inappropriate as an external committee member.
However, the measure of "strong influence" is considered to vary depending on various backgrounds, such as the scope of the committee member's authority, etc. Therefore, it is necessary for the sponsor to determine the appropriateness of the committee member on an individual basis based on information provided by the investigational review committee/Investigator Site.