Drug Evaluation Committee 2013-19 Clinical Trial Review Committee Review of Periodic Adverse Reaction Reports for Investigational Drugs Prior to the Conclusion of Clinical Trial Agreement
Related classification: Clinical Trial Review Committee
First published: August 2013
Question
The sponsor reported that a periodic report of an investigational drug was issued prior to the conclusion of a contract with our hospital, and that a report to the hospital director of this hospital was required. How should we handle the paperwork for safety information prior to entering into a contract?
Opinion of the Pharmaceutical Cooperative Association
Regarding the periodic safety information provided by the sponsor in accordance with GCP Article 20, Paragraph 2, the head of the site must hear the opinion of the IRB in accordance with GCP Article 31, Paragraph 2, and the IRB must review the appropriateness of continuation of the clinical trial in accordance with GCP Article 32, Paragraph 3. In addition, the investigator must promptly determine whether the safety information affects the subject's decision and whether the explanatory document for the subject needs to be revised in accordance with Article 54, Paragraph 2 of the GCP.
With regard to the safety information provided prior to the conclusion of the clinical trial agreement, there is no problem in having the investigator determine whether or not the explanatory document needs to be revised and having the IRB review whether or not the clinical trial can continue at the next IRB meeting.