16-18 November 2021
A new post, "Reference Safety Information (RSI) for Clinical Trials" has just been published on the MHRA Inspectorate blog. The post provides recommendations to improve safety reporting since the agency is still seeing unreported suspected unexpected serious adverse reactions (SUSARs) and absence of adequate risk mitigation measures due to incorrect use of the RSI.
The RSI is used to determine the expectedness of a Serious Adverse Reaction (SAR). If the serious event is considered related to the investigational medicinal product (IMP) and the serious reaction is not included in the RSI, this becomes a SUSAR and has to be reported to the MHRA. Inclusion of a SAR as an expected event in the RSI needs to be accompanied by an assessment of the benefit-risk profile of the IMP and ongoing trials. The competent authority will then decide whether the list of expected reactions and associated risk minimization measures are acceptable.
According to the agency, the purpose of the reporting obligation to national competent authorities (NCAs) is to:
The MHRA has listed common inspection findings, including the following:
In addition, at the end of the post, the MHRA Blog provides useful tips to improve compliance (e.g. tracking of RSI updates, performing of impact assessments and compliance reviews).
For more information please read the MHRA Post Reference Safety Information (RSI) for Clinical Trials- Part III on the MHRA Inspectorate Blog.