In case of a randomized clinical trial, the randomization procedure must be documented. Where a sealed code for each individual treatment has been supplied in a blinded, randomized study, it should be kept both at the site of the investigation and with the sponsor.
In the case of a blinded trial the protocol must state the conditions under which the code is allowed to be broken and by whom. A system is also required to enable immediate access to the information about treatment received by individual subjects in the case of an emergency. The system must only permit access to the treatment schedule of one trial subject at a time. If the code is broken, this must be justified and documented in the CRF.