A dated CV (not older than 2 years) and a declaration of interest from the principal investigator (PI) of each trial site must be submitted in CTIS for review, preferrably an unsigned version.
The use of the CV template provided below is strongly recommended.
A Declaration of interest template is available. The use of this template is mandatory.
Temporary change of principal investigator
In case of a temporary change in PI, a Substantial Modification on Part II must be submitted in CTIS to request authorisation for the temporary PI. The CV and declaration of interest of the temporary PI should be submitted, but the details of the original PI should be maintained under Trial Sites, and its CV and declaration of interest should not be deleted. This way, no changes are required in Part II when the original PI resumes its duties, it is sufficient to notify the authorities about this in the cover letter of the next substantial modification in CTIS.