Before a protocol can be used, it must be assigned an Implementation status. When first created, the protocol will be in Draft status. The users that have been assigned responsibility for signing off each stage should do so by clicking on the blue trial code in the protocol list:
This will load the Protocol Summary card, where, in the top left hand corner, you can select to move the protocol through each stage:
Continue with each stage until you reach Implementation. The trial layout can now be created for this trial.