12:19 Jul 13, 2010
Luskie, when exclusion and inclusion criteria include a life expectancy definition this generally does cover restricted expectancy irrespective of cause. For example, someone with whatever disease is under study plus a life-threatening head injury, or life-threatening liver or renal failure, could potentially get recruited under this exclusion criterion. It is never obvious that "other major concerns" are excluded, though these are often dealt with a catch-all "any other condition which in the opinion of the investigator ...". You cannot leave anything to inference in technical writing.
I find it odd on the basis of my experience writing dozens of CSRs and CSPs that one would restrict the life expectancy exclusion to life expectancy due only to the underlying disease. |