ECAmendment object

Ethical review mandatory for

Any substantial amendments

Responsible for notification of SA

Sponsor

Standard notification form available

Yes

Standard notification form

Submission via OsSC online portal.

Timeline Ethical review of SA (max nr days)

35 (single opinion within 20 days by lead EC + acceptance or rejection within further 15 days by local ECs)

Applicable national legal framework/ Reference

Section 10.1 Legislative Decree n. 211

Additional Information

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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