Project severe adverse events enables tracking of adverse events , and can capture a number of flags that relate to these.
The flags include :-
- was it drug related,
- was it device related,
- was it connected to this HREC,
- were death(s) involved,
- link to previous SAE.
A document can also be associated with the event, and outcomes listed.
Creating severe adverse events sets the status icon visible against the project, and the tooltip provides a basic listing of the events.
n.b. The meeting date selector offers only available meeting dates, except administrative users who can also select the previous meeting date.
n.b.b. The meeting management icon may also appear offering meeting status details in the tooltip.