ECTimelinesEthicalReview object
General timespan for single-centre studies (max nr days)
30
General timespan for multi-centre studies (max nr days)
60
ATMP/GMO trials (max nr days)
90
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
National legal framework in place
Yes
Additional Information
For multi-centre studies, the EC responsible for the principle investigator provides the favourable 'single opinion' after collaboration with the local ECs of the participating sites.
The local ECs have 30 days to issue their opinion on trial sites and qualification of investigators.
