S.L. 458.43 Art. 10Conduct of a clinical trial.

Amendments may be made to the conduct of a clinical trial following the procedure described hereinafter:

(a) (i) after the commencement of the clinical trial, the sponsor may make amendments to the protocol. If those amendments are substantial and are likely to have an impact on the safety of the trial subjects or to change the interpretation of the scientific documents in support of the conduct of the trial, or if they are otherwise significant, the sponsor shall preferably prior to implementation notify the Licensing Authority and the competent authorities of the Member States concerned of the reasons for, and content of, these amendments and shall inform the Ethics Committee or committees concerned in accordance with regulations 7 and 9, and where necessary;

(ii) a new informed consent has to be obtained from the trial subjects if so required by the Ethics Committee;

(b) the Ethics Committee shall, on the basis of the details referred to in regulation 7(2) and in accordance with regulation 8, give an opinion within a maximum of thirty-five days of the date of receipt of the proposed amendment in good and due form. If this opinion is unfavourable, the sponsor may not implement the amendment to the protocol. If the opinion of the Ethics Committee is favourable and the Licensing Authority has raised no grounds for non-acceptance of the above-mentioned substantial amendments, the sponsor shall proceed to conduct the clinical trial following the amended protocol. Should this not be the case, the sponsor shall either take account of the grounds for non-acceptance and adapt the proposed amendment to the protocol accordingly or otherwise withdraw the proposed amendment;

(c) without prejudice to paragraphs (a) and (b), in the light of the circumstances, notably the occurrence of any new event relating to the conduct of the trial or the development of the investigational medicinal product where that new event is likely to affect the safety of the subjects, the sponsor and the investigator shall take appropriate urgent safety measures which include information to the subjects, in order to protect the subjects against any immediate hazard. The sponsor shall forthwith inform the Licensing Authority and the competent authorities of the Member States concerned of those new events and the measures taken and shall ensure that the Ethics Committee is notified at the same time; and

(d) within ninety days of the end of a clinical trial the sponsor shall notify the Licensing Authority and the competent authorities of the Member States concerned and the Ethics Committee, that the clinical trial has ended. If the trial has to be terminated early, this period shall be reduced to fifteen days and the reasons clearly explained.