27. MODIFICATIONS TO THE PROTOCOL The investigator/sponsor shall submit a protocol amendment describing any change in the Phase II trial that affects the safety of subjects, the scope of the investigation, or the scientific quality of the study. Changes i n the protocol will be distributed to all investigators and persons responsible for the conduct of the study in advance of the announced date of change. Where necessary, training will be provided and records of the training kept if the change is significan t enough to require it. 28.