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)
+ 30
External expert advice required: Timespan (max nr days)
+ 90
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
Applicable national legal framework/ Reference
Chapter 3, Section 3(3) Regulation 2009 for clinical trials
Additional Information
NB! There are application deadlines applicable to all RECs, published for one year at a time!
(available on the REK website in section Application Deadlines)
