The Clinical Trials Regulations make provision for the sponsor and investigator to take appropriate Urgent Safety Measures (USMs) to protect a research participant from an immediate hazard to their health and safety. This measure can be taken before seeking approval from the competent authorities (MHRA in the UK) and ethics committees of all member states concerned.
Any urgent safety measure relating to a Clinical Trial of an Investigational Medicinal Product (CTIMP) should be communicated to the MHRA immediately. They advise that sponsors phone the MHRA Clinical Trial Unit and discuss the event with a safety scientist. The sponsor must then follow-up with notification in writing within three days* of the action being taken. The notification should be in the form of a substantial amendment and should describe the event, the measures taken and justification for the measures taken. The MHRA web pages give further detail of notification requirements.
*In the case of research during a pandemic period, Point 3 of The Medicines for Human Use (Miscellaneous Amendment) Regulations (PDF, 46 KB) has amended this timeline to “as soon as possible”.
The main research ethics committee (REC) must be notified immediately and in any event within three days, that such measures have been taken and the reasons why. NHS R&D offices will require notification in accordance with local policies/procedures.
Where applicable, oversight committees (such as the Data Monitoring Committee) should review information relating to urgent safety measures and report any recommendations to all relevant parties.
If the Principal Investigator (and not the sponsor) has instigated the USM, the sponsor should be notified immediately so that they can assess and report the USM within the timelines required.
For non-CTIMP research, the Chief Investigator must notify the main REC immediately of any USMs and in any event within three days. NHS R&D offices will also require notification in accordance with local policies/procedures.
The funder should be updated on all developments and actions as soon as possible.
Further reading & Workstream Documents:
- Joint Project Workstream Document: Pharmacovigilance (pdf, 344.05 KB) - Comprehensive guidance including Urgent Safety Measures.