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
Timespan counted from
Date of submission of valid application
National legal framework in place
Yes
Additional Information
The NBC shall submit its reasoned opinion on ethical issues to the applicant and the Icelandic Medical Agency (IMA).
