To the attention of contract-based research organisations
We hereby inform you that the following documents have been published on the NAMMD website, under heading “Clinical trials”, section “Information of interest for sponsors and Clinical Research Organisations”:
– Proposals for improvement of the dossiers submitted for support of the application for authorisation of a clinical trial;
– Proposals for improvement of the dossiers submitted for support of the application for approval by the NAMMD of an amendment to a clinical trial.
These have been issued following the identification of the need for publication of useful information for applicants.
Documents shall be updated in direct proportion with the identification of other proposals for dossier improvement.