ECTimelinesEthicalReview object

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

15 (for monocentric Phase I trials)

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


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


Applicable national legal framework/ Reference

Chapter VIII Art 11 Law 7 May 2004

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.