ECTimelinesEthicalReview object

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

max. 8 weeks, may be prolonged by another 8 weeks if METC needs more time

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

max. 8 weeks, may be prolonged by another 8 weeks if METC needs more time

ATMP/GMO trials (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

Related information is provided on the CCMO website in section Home>Investigators>Primary submission to the reviewing committee>Timelines reviewing committee

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