If the sponsor makes substantial modifications to one or more of the documents mentioned in the Article 6 of the 30th May 2005 Grand Ducal Regulation and that these modifications have or can affect the safety of the participants or change the interpretation of the scientific pieces which support the conduct of the trial, or if they are significant from any other point of view, the investigator will inform the CNER by sending him the following documents:

  •  9 copies of a document summarizing the amendments made to the initial version,
  •  9 copies of the new full version of the part in question with Track Changes
  •  The electronic version of these documents (on CD-Rom, USB key or by email)

The CNER then delivers its opinion within 35 days of the date of receipt of the proposed amendment in good and due form. In order to respect this deadline, the President may request the CNER members’ opinion by correspondence. If the CNER has changed his view concerning the ethical aspects of the study after this deadline, he gives its explicit or implicit agreement to the amendment which was submitted to him.

If the CNERs’ opinion for the amendment is unfavorable, the sponsor may put it in place only after having referred to the Ministry of Health as required in the Article 25 of the 28th August 1998 law on Hospital Establishments.

If the CNERs’ opinion is favorable, and if the investigator as well as the sponsor fulfilled all the other legal and lawful obligations in the matter, the sponsor continues the clinical trial by following the amended protocol.

Substantial and non-substantial amendments - more info

Payment for the submission of an amendment: See details here