Drug Evaluation Committee 2017-55 Persons Submitting Review Materials to Clinical Trial Review Committees
Related classification: Clinical trial contract procedures
Date first published: December 2017
Question
There is a provision in GCP Article 32, Paragraph 1 regarding review documents to be submitted to the Investigator Site Chairperson by the sponsor as stipulated in Article 10, Paragraph 1, is this considered the same as the documents to be submitted to the Investigator Site Chairperson by the sponsor as stipulated in Article 10, Paragraph 1?
Article 32, Paragraph 1/Section 2, Guidance 2 includes materials related to subject recruitment procedures, reports related to subject safety, and materials related to conflicts of interest, which are not included in Article 10, Paragraph 1, but are they considered to be included in the "other necessary materials" in Guidance 1 of the same article? Also, in that case, Article 32, Paragraph 1/Section 2, Guidance 2 states that "The latest of the following documents shall be obtained from the head of the Investigator Site, etc., as the subject of the review.
In actual practice, I assume that all review documents are submitted to the Investigator Site's Chairperson, who then submits them to the Clinical Trial Review Committee, but under GCP, if there are documents that are not specifically stipulated in Article 10, Paragraph 1, such as documents related to subject recruitment procedures, reports related to subject safety, and documents related to conflicts of interest, then those documents are not included. If it is considered unnecessary to submit such materials to the Chairperson of Investigator Site, it would be reasonable to consider that the sponsor may submit them to the Clinical Trial Review Committee. In that case, we believe that "the head of the medical institution, etc." in Article 32, Paragraph 1 and Paragraph 2, Guidance 2 would include the sponsor.
JPMA's Opinion
Please refer to Article 32, Paragraph 1 of the GCP and its guidance for documents required for review by the Clinical Trial Review Committee. In the guidance, the documents to be submitted in advance from the sponsor to the head of the Investigator Site are listed in Article 10, Paragraph 1. The "documents related to subject recruitment procedures," "reports related to subject safety," and "documents related to conflicts of interest" in your question do not necessarily have to be submitted by the sponsor, but may be submitted to the head of the Investigator Site by the principal investigator or clinical trial office. Therefore, the above materials do not fall under "(8) Other necessary materials" in Article 10, Paragraph 1, Guidance 1, but those specific to the protocol or those required by the investigational review committee for review.
The Investigator Site Director requests the review by the Clinical Trial Review Committee. Therefore, the materials necessary for review are basically submitted to the Investigator Site Chairperson.
On the other hand, "In cases where the sponsor, the Investigator Site Review Committee, and the head of the Investigator Site agree in advance, the sponsor may simultaneously notify the investigator and the Investigator Site Chairperson as well as the Investigator Review Committee of adverse reaction information, etc. (see Article 20, Paragraph 2 / 3, Guidance 4). (See Article 20, Paragraph 2/3, Guidance 4). We believe that the "etc." in "obtaining from the head of the Investigator Site, etc." in Article 32, Paragraph 1 / Paragraph 2, Guidance 2, refers to the "case where the sponsor submits materials directly to the Investigator Site Review Committee".