Drug Evaluation Committee 2014-33 Advertisement for recruitment of test subjects in patient groups (Part 2)
Related classification：Recruitment of human subjects
Date of first publication: December 2014
Question
In relation to question No. 2009-58, "Recruitment of human subjects advertising at patient groups," is it acceptable to provide information on recruitment of human subjects using information media (newsletters, booklets, websites, SNS, etc.) created and managed by patient groups in addition to flyers advertising clinical trials? If so, please advise us of any points to keep in mind.
Is it possible to report the information later under the investigator's name?
Opinion of the Pharmaceutical Manufacturers Association of Japan (PMAJ)
When providing information for the purpose of recruiting subjects by using information provision media created and managed by patient groups, there should be no problem if the information is provided in accordance with the "Guidelines for Providing Information for the Recruitment of Subjects for Clinical Trials (Revised Version)" published on the website of the Pharmaceutical Manufacturers Association of Japan.
Since the information you are planning to provide is for the purpose of recruiting subjects, it must be approved by each Investigational Review Committee as "materials related to procedures for recruiting subjects (advertising, etc.)" (GCP Article 32, Paragraphs 1 and 2, Guidance 2 (3)). In addition, when providing information on the name of the investigational site, investigator, or department, this information must also be reviewed by the investigational review committee and approved by the head of the investigational site. In addition, please consider in advance how to respond to inquiries regarding the provision of information, and if any costs are incurred between the sponsor and the patient organization for the use of the information media prepared and managed by the patient organization, and if such costs constitute funding or support for the patient organization, please contact the following If you are using information media created and managed by a patient organization, and if there is a cost between you and the sponsor that constitutes funding or support for the patient organization, please follow the "Transparency Guidelines for the Relationship between Corporate Activities and Patient Organizations," which are available on our website.