Drug Evaluation Committee 2007-01 Time of Designation of Clinical Trial Collaborators
Related classification: investigators, subinvestigators, etc.
First published: August 2007
Revised publication date: Apr. 2013
Question
We would like to inquire about the date of nomination of a clinical trial collaborator.
Currently, at our clinic, when a request for clinical trial review is submitted to the IRB, as soon as possible, the Chairperson of the Investigator Site appoints the investigator based on the list of investigator collaborators (including subinvestigators) prepared by the principal investigator, and reports to the committee members at the IRB (the investigator is appointed before the IRB).
However, a sponsor pointed out to us that it would be better to obtain the approval of the head of the Investigator Site for the investigator's assistant investigator after the IRB approval has been obtained. I had interpreted that the approval of the head of Investigator Site for investigational collaborators (including subinvestigators) should be done regardless of the IRB approval. If the IRB determines that the investigator is not qualified to be a clinical research assistant investigator, how about reapproving the approval of the investigator as a clinical research assistant?
JPMA's Opinion
Article 43 (Assigned Clinical Trial Physician, etc.), Paragraph 1 of the GCP stipulates that "The investigator shall prepare a list of the duties to be shared by the assigned clinical trial physicians or investigational collaborators, if any, involved in the relevant clinical trial. The same is stipulated in Article 43, Paragraph 1 of the GCP. In addition, Article 43, Paragraph 1, Guidance 1 of the GCP states, "When the investigator assigns a part of important tasks related to the clinical trial to a subinvestigator or a collaborator, the investigator shall prepare a list of tasks to be assigned and a list of persons to be assigned, and submit it to the head of the medical institution in advance for his/her approval. The Chairperson of the Investigator Site must approve the assignment of these duties, but the investigator must be reviewed by the Investigator Review Committee. The appointment of a subinvestigator is the responsibility of the principal investigator.
On the other hand, Article 32, Paragraph 1, Item 4 of GCP (Responsibilities of the Clinical Trial Review Committee) lists "the curriculum vitae of the person to be the principal investigator" as one of the materials required for the review by the Clinical Trial Review Committee. In addition, Article 32, Paragraph 1, Guidance 5 of the GCP states that "the investigator review committee shall examine whether the investigator is qualified to conduct the clinical trial by reviewing the latest curriculum vitae of the investigator, etc." The GCP states that "the investigational review committee shall consider whether the investigator is qualified to conduct the clinical trial.
In conclusion, the order of nomination of investigators and IRB review is not required. However, if the IRB does not approve the eligibility of the previously nominated investigator, the nomination must be redone based on the opinion of the IRB and the nomination list must be submitted to the sponsor and investigator.
Reason for revision
With the issuance of the GCP Guidance (December 28, 2012, Drug and Food Administration Review No. 1228-7), the provisions to be referenced have been changed.