I'm not sure if questions about statistics in the context of clinical trials belong to cross validated, especially if regulatory aspects come into play.
Example for such a question would be:
Before the database lock in a (blinded) clinical trial the statistician does a blinded data review (BDR). The statistician is blinded by replacing the treatment group assignments by "random variates". One task during the blinded data review is checking distributional assumptions. And here comes the question: What does "random variates" exactly mean? Does it mean that in a trial of medication versus surgery, the term "medication" is replaced by a random number, say 7, and "surgery" by another random number, say 42, so that 7 always stands for "medication" and 42 always for "surgery"? Or does it mean that a long random series of 0's and 1's are produced and copied over the original treatment variable? The 0 could mean "medication" sometimes and sometimes it could mean "surgery" (same for 1).
The point of this distinction is: If the first replacement is done, the groups are preserved but they are only masked by a new name. If the second replacement is done, groups are not preserved. In the second case I don't see how to check e.g. a normality assumption, as the 0-group and the 1-group are potentially mixed from 2 distinct normal distributions and therefore no more look like normal distributions. So the second approach doesn't make much sense to me but it would keep the blinding more effectively because the masked groups could easily be unmasked if one could see other variables which could take on only special values in one group, e.g. the variable "complications during surgery yes/no" could unmask the 0/1-group variable.
Maybe someone even knows what's to be done because there is a clearer guideline on that somewhere...
Do you guys think that questions like this should be posted on CV? Should there be a special tag for them? Should there be a new CV-spinoff on SE (I personally find this a bad idea as it would create a too closely related ressource)?