The team at SPIRAL have done a great job in putting together the eCRF which is now open for ICU-data input. Due to our continued effort to create a simple and harmonised CRF with the TAME-trial there are a few remainig issues that will remain until the entire system in online and has been tested. We expect this process to take about another month. The following are a few things to consider:
- The adverse event form is not yet online - no changed planned from the paper version
- The SAE-form and protocol deviation form is not yet online - If a protocol violation or a serious adverse events occurs until this system is up and running. Or if for any reason the website might be down a description of the SAE or protocol deviation should be sent by email to firstname.lastname@example.org
- The stucture of days in the eCRF is as follows: day 1 (a "short" day), from time of randomisation until the next break of "ICU-day". Day 2 and onwards will run from ICU-day to ICU-day. We apologise for the changes.
- You might notice some minor changes in phrasing and one or two new questions in the eCRF. One of which is time to target temperature (<=34°).
- An updated version of the paper CRF (which should correspond to the electronic version) will be distributed as soon as testing is complete.
Finally, a big thank you to everyone at the vanguard sites. Randomising more than 80 patients while still working out some of the kinks in the system is a great achievement.