PhEAST documents

This amendment changes the inclusion criteria, to include FOIS 3 for the whole enrolment period.
It also introduces independent physician consultees, whereby a personal consultee cannot be appointed.
The protocol and consultee information sheet and consultee declaration form has been updated to reflect this.
There are then a few minor wording / clarification changes within the protocol.

Trial documents


SA-07-23	This amendment changes the inclusion criteria, to include FOIS 3 for the whole enrolment period. It also introduces independent physician consultees, whereby a personal consultee cannot be appointed. The protocol and consultee information sheet and consultee declaration form has been updated to reflect this. There are then a few minor wording / clarification changes within the protocol. 21 EE 0252 304658 Favourable opinion of a substantial amendment SA0723.pdf 304648 SA 07 23.pdf SA0723 HRA HCRW Approval Email 20230425.pdf