Reference Safety Information - new Q&A document published

Thursday, January 11, 2018

The Q&A–RSI document of the Clinical Trial Facilitation Group (CTFG) has been updated and published at the website of the Head of Medicines Agencies under the heading key documents list, clinical trials safety.

The CTFG has updated this document following discussions between national competent authorities (NCA's) and sponsors, which arose from Clinical Trial Application and Substantial Amendment procedures as well as Good Clinical Practices inspections.

The Q&A-RSI document provides updated details on RSI requirements based on shared experiences since 2013. Specifically, the CTFG advises sponsors that the primary purpose of the RSI is to serve as the basis for expectedness assessments of suspected serious adverse reactions (suspected SAR's) by the sponsor for expedited reporting of suspected unexpected serious adverse reactions (SUSAR's) and annual safety reports (ASR). Thus, the RSI section of an investigator brochure should only contain expected SARs to the Investigational Medicinal Products (IMP's).

In addition, the updated CTFG Q&A-RSI document covers a number of important questions and answers such as the format of the RSI, the inclusion of life-threatening and fatal SAR's as expected in the RSI, the use of preferred and synonym terms, preferable locations of the other relevant safety information and recommendations for the RSI/Investigator's brochure updates, etc. It aims at reducing complexity and at ensuring consistent approach by sponsors in relation to RSI generation, which will allow for efficient supervision of clinical trials. The document will also support and ensure harmonised requirements and decision by NCA's in EU.


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Mårten Wendt, MD, PhD
Specialist Nephrology and Internal Medicine
Department of Clinical Trials and Special Permissions




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