ECTimelinesEthicalReview object
General timespan for single-centre studies (max nr days)
28
15 (for monocentric Phase I trials)
General timespan for multi-centre studies (max nr days)
28
ATMP/GMO trials (max nr days)
+ 30
(up to 90 days if the Belgian Biosafety Advisory Council has to be asked for advice)
Xenogeneic cell therapy: Timespan (max nr days)
No time limit
Clock-stop possible if complementary information requested
Yes
Additional Information
The ethics committee has to give a written reply and submits a copy to the CA.
ad multi-centre trials: Lead -EC delivers opinion within 20 days to local ECs of participating sites, local ECs have 5 days to respond to Lead -EC, Lead-EC has 3 days to issue final single opinion to investigator.