Scope of the Guideline

To outline the practical arrangements for notification of serious breaches; this document does not cover notifications related to unexpected events, other reporting obligations related to the safety of trial participants or urgent safety measures, as defined in Articles 53 and 54 of the Regulation (EU) No 536/2014.

To provide advice on what should and what should not be classified as a serious breach and what must be reported.

To outline possible actions that may be taken by the EU/EEA Member States concerned (MSC) in response to notifications of serious breaches.

Serious breaches occurring in clinical trials authorised under the Directive 2001/20/EC cannot be reported through the EU portal and EU database – part of the Clinical Trials Information System (#CTIS).

In such cases, national requirements in place before the Regulation (EU) No 536/2014 became effective apply.

The sponsor is responsible for the notification via the EU portal and EU database – part of the CTIS.

The sponsor may delegate this task to a service provider by means of a written agreement as described in Article 71 of the Regulation (EU) No 536/2014.

The notification should be made without undue delay and at the latest within 7 calendar days of the sponsor becoming aware of a serious breach.