Drug Evaluation Committee 2014-43 Review of a clinical trial review committee at your hospital for a subject recruitment poster for a clinical trial at another hospital

Related classification: subject recruitment

Date of first publication: February 2015

Question

A physician in the relevant department 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 the relevant department at 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?

JPMA's Opinion

The recruitment poster for a clinical trial falls under GCP Article 32, Paragraph 1, Item 2, "Materials related to procedures for recruiting subjects," so the clinical trial review committee (in the case of your question, the clinical trial review committee of the university hospital), which hears opinions from the Chairperson of the medical institution concerned, must review the poster, including its location (at your hospital). 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.

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