NEWS

NATIONAL SUBMISSION VHP 

Clarification regarding Submissions of the CTA to CEIC after VHP procedure ++

Regarding submission of the CTA to CEIC, after the conclusion of the VHP procedure, in which CEIC has participated in the ethical evaluation of the Protocol and Investigator Brochure, we informed that the request applicant has 20 calendar days to submit the trial to CEIC.
For more informations regarding the procedure, please consult the guidance published by the Clinical Trials Facilitation Group - CTFG, available in:
Guidance document for sponsors for a Voluntary Harmonisation Procedure (VHP) for the assessment of multinational Clinical Trial Applications .