Drug Evaluation Committee 2017-55 Persons Submitting Review Materials to Clinical Trial Review Committees
Related classification: clinical trial contracting procedures
Date first published: December 2017
Question
Is it correct to think that the review documents to be submitted by the sponsor to the head of the investigational site as stipulated in Article 10, Paragraph 1 of the GCP?
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 "The latest of the following documents shall be obtained from the head of the implementing medical institution, etc., as the subject of the review".
In actual practice, I assume that all review documents are submitted to the head of the implementing medical institution, which is then submitted to the Clinical Trial Review Committee, but under GCP, if 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, are not included in the "etc."? If it is considered that materials that are not specifically stipulated in Article 10, Paragraph 1, such as materials related to subject recruitment procedures, reports related to subject safety, and materials related to conflicts of interest, do not need to be submitted to the head of the implementing medical institution, it would be reasonable to consider that the sponsor may submit them to the investigational 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.
Opinion of the Pharmaceutical Manufacturers Association of Japan (PMAJ)
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 investigational 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 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 review by a clinical trial review committee is requested by the head of the implementing medical institution. Therefore, the materials necessary for review are basically submitted to the investigational review committee by the head of the site.
On the other hand, "In cases where the sponsor, the investigational review committee, and the head of the implementing medical institution agree in advance, the sponsor may simultaneously notify the investigational review committee in addition to the principal investigator and the head of the implementing medical institution 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 site, etc." in Article 32, Paragraph 1 and Paragraph 2, Guidance 2, refers to the "case where the sponsor submits materials directly to the investigational review committee".