ECTimelinesEthicalReview object
General timespan for single-centre studies (max nr days)
60
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
Applicable national legal framework/ Reference
Art 6 modified RGD 30 May 2005
Additional Information
NB: There are submission deadlines for initial applications:
at the latest three weeks before the date of the next CNER meeting (every 2nd month). The exact meeting dates and their respective submission deadlines are provided on the CNER website.
Copies of the opinion issued by the EC are sent to the CA and the National Data Protection Authority.
