Reference Safety Information (RSI) for Clinical Trials – Part III

On 5 February 2021 the MHRA GCP inspectorate published the RSI blog posts Part III.

Since RSI blog posts part I and II were released, the MHRA GCP inspectorate has continued to see non-compliance in this key aspect of pharmacovigilance. While additional guidance was released by the Heads of Medicines Agencies, Clinical Trials Facilitation and coordination Group (CTFG), unreported suspected unexpected serious adverse reactions (SUSARs) and absence of adequate risk mitigation measures due to incorrect use of the RSI are still being seen.

The MHRA GCP inspectorate completed a pilot of office-based inspections (OBI) focusing on clinical trials’ pharmacovigilance and the RSI. Two organizations were selected for the pilot: critical findings were identified in both. The RSI OBIs have now been incorporated into the routine inspection programme.

Since 1 January 2019, the MHRA GCP inspectorate has identified 8 organizations with critical findings when reviewing RSI on inspection. Given the number of non-compliances observed, it was thought to be helpful to outline continuing issues and how compliance can be improved.

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