The Q&A-RSI document provides updated details on RSI requirements based on shared experiences since 2013.
The Q&A–RSI document of the Clinical Trial Facilitation Group (CTFG) was published on November 12, 2017 and applicable from the publication date.
The CTFG has updated this document following discussions between national competent authorities and sponsors, which arose from Clinical Trial Application and Substantial Amendment procedures as well as Good Clinical Practices inspections.
The preparation of the document was led by the Belgian expert, Elena Prokofyeva, of the Division R&D (human) of the FAMHP.
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 SARs) by the sponsor for expedited reporting of suspected unexpected serious adverse reactions (SUSARs) and annual safety reporting (ASR). Thus, the RSI section of an investigator brochure should only contain expected SARs to the Investigational Medicinal Products (IMPs).
In addition, the updated CTFG Q&A-RSI document covers a number of important Q&A such as the format of the RSI, the inclusion of life-threatening and fatal SARs 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 supervision of clinical trials.
Finally, the publication of the Q&A-RSI document by CTFG will support and ensure harmonised requirements and decisions from NCAs across Europe.