Urgent safety measures

Where an unexpected event is likely to seriously affect the benefit-risk balance, the sponsor and the investigator shall take appropriate urgent safety measures to protect the subjects.

The event and the measures taken should be reported in CTIS without undue delay but no later than 7 days from the date the measures have been taken.

If urgent safety measures are required while any assessment is still ongoing, the sponsor should take the appropriate measure and notify the MSc. A substantial modification can then be submitted once the ongoing substantial modification is finalized or when the substantial modification under assessment is withdrawbn.

See also Question 3.7 and 4.3 of the Q&A CTR.

More information can be found in the section Substantial modifications.