If the study is randomized, a randomization list must be prepared. The decision on how to stratify it is a responsibility of the statistician experts. The randomization list provides the possibility to randomly associate the treatment of an RCT according some criteria selected during the study design (Stratification, Blindness, groups, etc). This list has to be stored during the trial in a section of the Trial Master file and into each sites ISF to allow the possibility of the allocation of the treatment in any cases. The Randomization process could be done online by using dedicated platform or by using a module of the eCRF (IWRS) or by Phone with a guided voice.
