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SD0087
Forums: Validation Rule Suggestions
m
Max
on March 30, 2010
P21
Re: SD0087
Hi Victor,
In your case it's acceptable to leave RFSTDTC missing since the variable is Expected. The SD0087 validation rule is marked as a Warning so this validation criteria is not absolute.
Regards,
Max
For the study I'm currently working on there are subjects that were randomized but for whatever didn't receive the study drug (some withdrew before taking drug, others failed screening criteria after the fact). In this case they are randomized however they did not receive any drug. Now it make sense to me that RFSTDTC be calculated the same for all subjects so in my case the RFSTDTC value would be missing since I'm basing it off the start of study drug. I'm not entirely sure if need to change my definition so that these patients don't have missing dates (as in make RFSTDTC consent date or randomization date for all subjects) and follow this rule. The other option is to allow it to be missing since RFSTDTC is an expected variable rather than required. Is the validation criteria absolute?