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AD0190/AD0191
j
John
on December 18, 2015
What aredetails of how these rules are implemented? Would a variable ATOXLO or ATOXHI be identified as missing a numeric 'y' component to the variable name?
m
Michael
on December 21, 2015
That is correct
You can verify quickly with an empty BDS csv file that has those variables. The standard suggests that a variable of these forms must have a value for 1-9 for the letter y.
- AyLO
- AyHI
- R2AyLO
- R2AyHI
therefore you would get these messages:
AD0190: Illegal variable name: y is not in [1-9] for (R2)AyLO - ATOXLO
AD0191: Illegal variable name: y is not in [1-9] for (R2)AyHI - ATOXHI
AD0191: Illegal variable name: y is not in [1-9] for (R2)AyHI - ATOXHI
there are 4 known exceptions where this rule won't fire:
- AWLO , ANRLO
- AWHI , ANRHI
Because variables can only be 8 characters, perhaps we could narrow down the rule to only fire when the "y" is replaced by a max of 2 characters. So things like A0LO, A99LO would fail, but ATOXLO would not. It becomes trickly because what about A111LO or AT99LO. Should these be allowed ?
Regardless, the configuration of rules is XML, so you can add your own exceptions like ATOXLO and ATOXHI to limit this validation. You would then submit your explanation in your ADRG so the FDA knows about it. The other solution is to simply name the variables TOXLO and TOXHI. The long term solution is for clearer guidance in ADaM 1.1 IG.
Because ADaM is a loose standard (more like a guideline), these occurences will continue to happen until there is consensus. That's why we make the validator flexible for users to tweak the rules in their environment if necessary (although easier with enterprise than community).
With ADaM 1.1, new variables like AyLOC, AyHIC will be added and these will not trigger the above rule. A modification of the existing rule would now have to recognize the optional "C" value. of course, the same problem will arise if someone has a custom variable called ALOC or AHIC unless those are reserved or prohibited from use.
We are doing our best to represent the rules as faithfully as possible to the published rules and IG. But with any effort (commerical or free) there may be bugs in the software or implementation, or times where decisions need to be made in favor of waiting for consensus.
Thanks in advance for understanding
Mike.
