Suitability of the investigator

A recent CV and a declaration of interest from the principal investigator per investigational site must be submitted for review.

A signed version of the CV should be included in the trial master file. However, a signed version is not required for the application. If a signed version is submitted, also an unsigned version should be submitted (for publication).

A CV template is available.

A Declaration of interest template is available. The use of this template is mandatory.