Updated guidance from the Clinical Trials Facilitation Group for Reference Safety Information

Updated guidance, in the form of a Q&A document, has been released by the Clinical Trials Facilitation Group (CTFG) for the reference safety information (RSI) for a clinical trial.

The update comes a result of extensive discussions between national competent authorities and sponsors, which arose from Clinical Trial application and substantial amendment procedures as well as GCP inspections. The MHRA recommends full compliance with the Q&A from mid-February 2018.

To view the full updated guidance regarding RSI, please click here.