Safety reporting: general information

The safety reporting requirements for investigator and sponsor are set out in Chapter VII and annex III of the CTR for (serious) adverse events, SUSARs and annual safety reporting. 

In Chapter VIII of the CTR additional sponsor obligations with respect to subject safety is given (see section on Notifications).

An extensive guidance on the safety reporting requirements are given in chapter 7 of the Q&A CTR.

Safety assessing Member States

In accordance with article 42 and 43 of the CTR the sponsor should report SUSARs in Eudravigilance database and submit Annual Safety Reports to CTIS. The safety information shall be forwarded to the MSc. The CTR request work sharing in the assessment of this safety information. Therefore for each new active substance in CTIS, a socalled Safety assessing Member States (saMS) will be appointed to assess the submitted safety information. The saMS shall carry out the assessments for all investigational medicinal products containing the same active substance, regardless of pharmaceutical form, strength or indication investigated and regardless if they are used in several trials with different sponsors. This means that a member state can be the saMS of an CT application with a certain active substance, irrespective whether it received the application as a MSc or not.

The saMS will share the assessment with all MSc. When necessary, after screening the reported safety information, the saMS shall contact the sponsor to request further information. The saMS may recommend corrective actions or other risk mitigating measures in accordance with Article 77 of the CTR to the rMS and to MSc.

An implementing regulation sets up the rules and procedures for the cooperation of the Member States in safety assessment of clinical trials. There will only be saMS for active substance for which clinical trials are running in more than one MSc. For active substances where there is only one clinical trial running in one MSc, this MS is responsible for the safety assessment. Auxilliary medicinal products, authorised comparators and placebo's are outside scope of this Implementing Regulation.