Drug Evaluation Committee 2017-18 Review of Clinical Trial Participation Cards, etc. by Clinical Trial Review Committees
Related classification: Clinical Trial Review Committee
Date of first publication: July 2017
Question
Article 10 of the GCP Ministerial Ordinance stipulates "prior submission of documents to the head of the site. Article 10 does not include "clinical trial participation cards" and "specific schedules for clinical trials" as documents to be submitted to the site, and we have heard that the necessity of review by a clinical trial review committee varies from site to site. I have heard that not a few medical institutions review the clinical trial participation card at the Clinical Trial Review Committee, but please tell us which documents and dossiers given to subjects are considered to require review by the Clinical Trial Review Committee.
Similarly, please let me confirm that documents such as asking a medical practitioner in the same field of medicine who is not conducting a clinical trial to introduce a potential subject do not need to be reviewed by the Clinical Trials Review Committee.
Opinion of the Pharmaceutical Manufacturers Association of Japan (PMAJ)
Materials subject to review by the Clinical Trial Review Committee are stipulated in GCP Article 32, Paragraph 1, Items 1 through 5. There is no direct mention of "clinical trial participation cards" or "specific schedules for clinical trials" in them. However, since materials to be provided to subjects or used for explanations to subjects are important materials that affect subjects' decision to participate in a clinical trial and the safe and proper conduct of a clinical trial, it is necessary to determine the necessity of review for each of these materials.
In addition, although the request for referral of subjects to physicians at other medical institutions generally does not need to be reviewed by a clinical trial review committee, the necessity of review should be determined on an individual basis, taking into consideration the scope of information to be provided and how the information will be used at the site of provision (see past Opinions 2008-31 and 2012-47). 47).