Drug Evaluation Committee 2014-43 Review by an Institutional Review Board of a Clinical Trial of a Poster for Recruitment of Subjects for a Clinical Trial at Another Hospital
Related classification:Recruitment of human subjects
Date of first publication: Feb 2015
Question
A physician from a nearby university hospital asked us if we could put up a recruitment poster for a clinical trial being conducted at a nearby university hospital in the outpatient department of our hospital. We are not planning to conduct that clinical trial at our hospital.
If the poster is approved by a university hospital, is it acceptable to post it in our hospital without IRB review or other procedures?
Opinion of the Pharmaceutical Manufacturers Association of Japan (PMAJ)
The recruitment poster for a clinical trial falls under GCP Article 32, Paragraph 1, Item 2, "Materials related to procedures for recruiting subjects," so it must be reviewed by the Clinical Trial Review Committee (in the case of your question, the University Hospital's Clinical Trial Review Committee), which is the committee that receives opinions from the head of the medical institution concerned, including the location (your hospital) where the poster is to be posted. However, the committee will not be able to review the poster at the medical institution where the poster is displayed. However, review by the clinical trial review committee at the medical institution where the poster will be posted is not required under GCP. After confirming that the clinical trial review committee at the site has approved the poster, we believe that there will be no problem in making a decision in accordance with the rules for displaying posters and other advertising materials at your hospital.