4 ms·

I'm a little confused here. All trials have to be reported within 12 months of completion, and the law goes into full effect in February. So the tool gives the

I'm a little confused here. All trials have to be reported within 12 months of completion, and the law goes into full effect in February. So the tool gives the trials which have been overdue for some part of February? The "US govt could have imposed fines" part seems to be way off too (unless maybe it's in thousands?). It says they can levy fines of $10k/day. Just clicking on one company, Bassett Healthcare, shows there is 1 trial overdue by 32 days. Only 22 days have elapsed in February (when it sounds like this portion of the law went into effect), so shouldn't that company be able to be fined at least 22*$10k=$220k? It has the total for all companies at $290k on the home page. Maybe I'm misunderstanding something, but the tool doesn't have a lot of description that I could find.

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.