The CT College Board clarifies the role of the Ethics Committees (ECs) in evaluating clinical trial safety reports submitted under the European CTR.

According to art. 44 of the CTR, evaluative ethics committees should be involved in the assessment of the annual safety reports (ASR) and the reports on suspected unexpected serious adverse reactions (SUSAR) of clinical studies, only if required by the national legislation of the safety assessing member state (saMS).

However, the Belgian law of 7 May 2017 on clinical trials on medicinal products for human use does not mention a mandatory involvement of the evaluating ECs with regard to the assessment of ASRs and SUSARs.

The Board of the CT-College thus concludes that for the assessment of ASRs and SUSARs of CTR files:

• the ECs are not responsible according to Belgian law;

• the ECs are therefore not assigned a formal role in CTIS for this matter.


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