Drug Evaluation Committee 2012-10 "Types of Clinical Trial Review Committees" to be described in the explanatory document for subjects
Related classification: Obtaining consent
First published: June 2012
Question
Regarding the description in the explanatory document, Article 51, Paragraph 1, Item 15 of GCP states "Types of Clinical Trial Review Committees" and Article 51, Paragraph 1, Guidance 3 (1) of GCP states "The types of Clinical Trial Review Committees refer to the different types of Clinical Trial Review Committees and Specialized Clinical Trial Review Committees.
In the text of the explanatory document for a certain study, "The contents of this study ... will be further reviewed by the Clinical Trial Review Committee* and ・・・・・・・," and the following description is provided in a separate box below the text as "Explanation of the word *(asterisk)".
The following is a separate explanation of the word "*(asterisk)" below the sentence: "*Investigational Review Committee
(Matters to be reviewed) ・・・・・・・・・・・・
(Name) ・・・・・・・・・・
(Location) ・・・・・・・・・・・・・・
(Establisher) ・・・・・・・・・・・・・・・・
(HP address) ・・・・・・・・・・・・・"
When we inquired with the sponsor, "The type of investigational review committee is not listed," the sponsor replied, "Since it says '*Investigational Review Committee,' it should be decipherable that it is not a specialized investigational review committee. The sponsor responded, "Since it says '**Investigational Review Committee,' it should be easy to read that it is not an expert investigational review committee. Is it a correct interpretation of GCP that "since it does not say 'expert investigational review committee,' it can be read as 'investigational review committee'"? With this description, is it considered that the requirement regarding GCP Article 51, Paragraph 1, Item 15 is fulfilled?
Opinion of the Pharmaceutical Manufacturers Association of Japan (PMAJ)
As stipulated in Article 30, Paragraph 4 of the GCP, a specialized investigational review committee is a committee that hears the opinions of the investigational review committee when the head of the implementing medical institution, in hearing the opinions of the investigational review committee, finds it necessary to have the committee investigate and deliberate on specific specialized matters that form the premise for determining the suitability of conducting a clinical trial.
On the other hand, as you mentioned, GCP Article 51, Paragraph 1, Item 15 requires that the explanatory document include "the types of the investigational review committees that will investigate and deliberate on the appropriateness of the clinical trial, matters to be investigated and deliberated by each investigational review committee, and other matters related to the investigational review committee for the clinical trial in question". Therefore, when opinions are also sought from the expert investigational review committee in deciding whether or not to conduct the relevant clinical trial, the explanatory document must include matters pertaining to both investigational review committees. Since the opinions will not be sought only from the specialized investigational review committee, if only one investigational review committee is mentioned in the explanatory document, it can be interpreted that it is not a specialized investigational review committee, so there should be no problem even if the type of the said investigational review committee is not mentioned.