August Update - 192 participants
Summer is almost over, and we are expecting a big increase in recruiting over the next couple of months. Over the summer, recruitment has started in Switzerland, France, Germany, UK and the US and we now have 22 active sites in 10 countries. So far 179 participants have been randomized in the TTM2-trial and 192! in TTM2 and TAME combined. More sites are about to open up, especially in the UK, where Bristol, Basildon and Belfast are almost ready to start.
eCRF-Update
Spiral will be migrating the TTM2-TAME database on Wednesday, 29th August 2018 at 7PM UTC which means that there will be a short window of approximatley 30 minutes where randomisation will not be possible. Please check out the randomisation page for information on this.This update will also include a system for reporting unexpected seroius adverse events and protocol deviations which means that they no longer need to emailed seperatley. If you are unsure about the definitions of unexpected serious adverse events and protocol deviations please contact us at ttm2@ttm2trial before reporting.
Following this update we will work on creating user accounts for all outcome assessors. Hopefully these will be available within a few weeks.