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)
+ 90
Xenogeneic cell therapy: Timespan (max nr days)
No time limit
Clock-stop possible if complementary information requested
Yes
Timespan counted from
Date of receipt of valid application
Additional Information
The applicant must provide details of the EC opinion to the HPRA as soon as it is available to ensure that all Irish records are released and published on the EU Clinical Trials Register.
