ECTimelinesEthicalReview object

General timespan for single-centre studies (max nr days)

General timespan for multi-centre studies (max nr days)

60 (30 days Lead EC + 30 for local ECs of collaborating centers)

ATMP/GMO trials (max nr days)

External expert advice required: Timespan (max nr days)

180

Xenogeneic cell therapy: Timespan (max nr days)

No time limit

Clock-stop possible if complementary information requested

Yes

Timespan counted from

Date of submission of valid application

Applicable national legal framework/ Reference

Section 6.3-5 Legislative Decree n. 211(Single-centre trials)
Section 7 Legislative Decree n. 211 (Multi-centre trials)

Additional Information

Ad Mulit-centre trials: The single opinion has to be expressed within 30 days from the date of receipt of a valid application; the ECs of the participating sites may send its comments to the EC issuing the single opinion. The final single vote shall be notified to the sponsor, the other ECs involved and the Ministry of Health.
The extension time spans applicable for single-centre trials (e.g.: + 30 days in case of advanced therapies) also apply to the EC expressing the single opinion.
Within a maximum of further 30 days from the date of receipt of the single opinion, the ECs of the collaborating centres shall notify the sponsor, the other committees and the CA of their acceptance or rejection of the single vote.

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