10. Can the risk assessment be amended?

Yes. In fact it would be expected that the sponsor undertakes a continual review of the risk assessment, which is particularly important when new information becomes available. For example, the risk assessment should be re-examined following a protocol amendment or when new data is obtained (new SmPC, related pre-clinical/clinical trial results are released, a data monitoring committee meeting or interim analysis takes place). If the risk assessment is reviewed and it is not updated, the sponsor should document that the review has taken place. It is important when applying a quality risk management process that systems are in place for identification of new or unanticipated risks and taking appropriate actions. For example, a serious breach may occur and this may result in an amendment to the risk assessment with additional, changed or new mitigating actions required, such as changes to the type and/or frequency of monitoring.
Version 1: 01 March 2012