CAAmendment object

Authorisation mandatory for

All clinical trials requiring authorisation by CA

Responsible for submission of SA

Sponsor

Timeline for approval of SA (max nr days)

Not specified

Applicable national legal framework/ Reference

Section 10.1 Legislative Decree n. 211/2003

Additional Information

The sponsor shall use the OsSC to notify the CA and the EC(s) concerned of any substantial amendments. Non-substantial amendments only require notification of the EC(s) without approval.

If the EC’s opinion is favourable and the CA has raised no grounds for non-acceptance, the sponsor may implement the amendment.

This project (ECRIN Integrating Activity/ECRIN-IA) has received funding from the European Union’s Seventh Framework Programme for research, technological development and demonstration under grant agreement no 284395
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