3 ms·
The fines would be administered for each day the trial is late. Technically, sponsors have 1 year to post results after the primary completion date stated on ct
by wireblitz 9y ago
The fines would be administered for each day the trial is late. Technically, sponsors have 1 year to post results after the primary completion date stated on ct.gov. This is supposed to be the anticipated date that the last primary outcome measure is collected. Therefore, if a sponsor estimated to collect that final measure on 12/1/2018, they would need to have results registered on ct.gov on 12/1/2019. If they were missing results on 12/2/2019 (and there are no certified delayed results) they'd be fined 10K for that day. Also worth noting that the sponsor would receive a notice that their out of compliance and have 30 days to rectify before a fine is issued.