Rule AD0129 - AD0130, AD0149 - AD0150

Rule AD0129 - AD0130, AD0149 - AD0150 - answer

short answer:

You are correct that only one of AVAL or AVALC are required by ADaM.   Yes, I believe we need to only run the rule when AVAL is not null in 149 and AVALC is not null in 150.  (same applies to BASE and BASEC) and possibly 109/110 (AVISIT & AVISITN within PARAMCD).  Thanks for discovering this.

Long answer , sample data and quick fix (for those wanting more....)

Here's the abbreviated version of how the rule is implemented in OpenCDISC.  The code in red can be applied to your config to fix the issue until it's released in next version

* note that This rule is not to ensure that AVAL = AVALC for each distinct PARAM.   

1. In AD0149, The idea is that only for a given combo of PARAMCD + AVAL, … AVALC must be mapped consistently. 
2.  Here you can see that record 6 will fail because the validator already associated {MIGRAINE,1} with Mild Pain in record 3.  
3. So in record 6, {MIGRAINE,1} with BAD Pain will trip the rule and throw an error.  
4. The issue you are facing deals with nulls.  
5. By only running the rule when the params you group by are NOT NULL, this should solve your issue and records 11,12,14,15 should not fail anymore

Sincerely

Mike DiGiantomasso

Pinnacle 21

Rule AD0129 - AD0130, AD0149 - AD0150 - answer

Hi Mike,

that sounds great. However, no changes on AVISIT and AVISITN is needed. See guideline 'there is a one-to-one mapping between AVISITN and AVISIT '

Regards,

Natalie

Rule AD0129 - AD0130, AD0149 - AD0150

Hi Mike,

now we are using the validation checks, version 1.2.1, and the above rules are not incorporated. My understanding was, that it would be corrected/implemented in the new version. We wouldn't like to do such changes to the program by ourselves, as every new version would produce the same warnings/errors, which would need to be updated every time.

Do you think, the rules above will be incorporated in the next version by the OpenCDISC team.

Thanks,

Natalie 

ADaM versions

Hi Natalie

Sorry for the confusion and delay.    At this time, OpenCDISC Validator software engine is at v1.2.1 released in April 2011.   This ships with multiple configuration files, all having their own version.    We can actually release just a new version of the ADaM checks, but to date, all rule changes have always been coupled with an actual software release.  

config-adam-1.0.xml   (still at Version 1)

config-define-1.0.xml

config-sdtm-3.1.1.xml

config-sdtm-3.1.2.xml

Currently, the CDISC ADaM Compliance subteam (led by Chris Decker for which I participate on) is working on the ADaM Validation Rules v1.2.    I anticipate that once those rules are finalized, we release a new version of the ADaM rules which incorporates all these changes.  I completely understand that you don't want to update the changes each time.    The good news is that this concept of "centrally managing the rules" is being addressed by OpenCDISC enterprise version which should be available by the end of the year.

I'll keep you posted once the revised ADaM 1.0 checks are available.

(and keep in mind 1.0 is the version of the ADaM IG... :)

AVISITN and AVISIT within PARAMCD

Hi Natalie, just to let you know, i'm working on fixing all these issues and implementing the CDISC ADaM Validation Checks 1.1.   We plan to release them this march with our 1.3 version of the validator engine

As part of the 1.1 release, CDISC issued a text change for 109 to clarify that AVISITN and AVISIT should be the same for a given PARAMCD.   However the same thing was not asserted in rule 110.  In general i believe it was stated correctly in 1.0 such that PARAMCD should be ignored.   I have alerted this to the CDISC ADaM validation team.

SHIFTy and SHIFTyN

ADaM 1.1 checks also specify that SHIFTy and SHFITyN should only be consistent ONLY within a PARAMCD.  This seems to make sense.   Do you agree ?

SHIFTy and SHIFTyN

HI,

yes that makes also sense to me.

Thanks for providing an update.

Kind regards,

Natalie