The principal investigator or, as the case may be, the investigator, the supervisor of the trial in the case of a multi- centre clinical trial, the sponsor or the sponsors representative, must submit a written, reasoned notification to the Icelandic Medicines Agency and the NBC when modifications are made to a clinical trial protocol that will:
- bring about changes to the patients safety;
- result in a change in the interpretation of the results;
- bring about substantial changes to a previously approved trial protocol.
The NBC must assess and approve any substantial modifications to a previously approved trial protocol.The NBC must deliver its opinion on rejecting or approving the modifications within 35 days.
Please note that substantial alteration in the handling of personal information may be subject for consideration by the DPA.