F. Potential actions by the MHRA:
Upon receipt of a serious breach notification, the MHRA will log and review the notification, and a variety of actions may be taken, depending on the nature of the breach and its potential impact e.g.
• Acknowledgement of receipt, but no immediate action e.g. if appropriate action has already been taken by the sponsor. The case may be examined during future MHRA inspections.
• Request for additional information from and investigation by, the Sponsor. If insufficient information is provided in the initial notification to assess the impact of the breach, follow-up information will be requested.
• Sharing of information with other concerned parties, in accordance with the regulations and applicable agreements e.g. to concerned Ethics Committees, other competent authorities, MHRA Clinical Trials Unit.
• Investigation by the MHRA, for example, triggered inspection(s).
• Implementation of urgent safety measures, where appropriate.
• Suspension or termination of a clinical trial authorisation, where appropriate.
• Referral for enforcement action e.g. infringement notices, criminal investigation.
• Referral to professional bodies e.g. the General Medical Council.