j Joan
on

 

Hello,

This message comes up repeatedly as an Error finding, for valid label text for TRTSDT, TRTEDT, PARCAT1N, CRIT1, CRIT2, CRIT3, ..., CRIT1FL, CRIT2FL, ... .  I sent an email to you also, with screenshot.

AD0018 is being tested also against custom added variables, for which I don't believe the check should be applied.

Can this be addressed? Thank you for all the hard work!

- Joan

Forums: ADaM

j Joan
on April 21, 2013

Hi,

I am adding here specifics to help with resolution.  
From the configuration file, the definitions for labels associated with these variable names don't seem to be working right for the new version 1.4.  See comments I inserted beneath the configuration definitions.

<ItemDef OID="PARCAT1N" Name="PARCAT*N" DataType="integer" Length="8" def:Label="Parameter Category 1 (N)"/>

            <!-- The label def is not working properly for our variable PARCAT1N, named "Parameter Category 1 (N)" -->

 <ItemDef OID="CRIT1" Name="CRIT*" DataType="text" Length="200" def:Label="Analysis Criterion 1"/>
<ItemDef OID="CRIT1FL" Name="CRIT*FL" DataType="text" Length="1" def:Label="Criterion 1 Evaluation Result Flag"/>
<ItemDef OID="CRIT1FN" Name="CRIT*FN" DataType="integer" Length="1" def:Label="Criterion 1 Evaluation Result Flag (N)"/>

<!-- The validator needs to permit these kind of labels for other integers > 1 as well, like 2, 3, ... , 9, 10 -- we have multiple criteria in our data -->

 

  <ItemDef OID="*EDT" Name="*EDT" DataType="integer" Length="8" def:Label="End Date of _"/>
<ItemDef OID="*FL" Name="*FL" DataType="text" Length="1" def:Label="Other User Defined Population Flag"/>

<ItemDef OID="*SDT" Name="*SDT" DataType="integer" Length="8" def:Label="Start Date of _"/> 

<ItemDef OID="TRTEDT" Name="TRTEDT" DataType="integer" Length="8" def:Label="Date of Last Exposure to Treatment"/>

<ItemDef OID="TRTSDT" Name="TRTSDT" DataType="integer" Length="8" def:Label="Date of First Exposure to Treatment"/>

In all domains, we have the var names TRTEDT and TRTSDT and the exact var labels -- yet these are coming up in validator version 1.4 as non-match. Could the variable definition statements for "*EDT" and "*SDT" (pasted above) be conflicting with the definitions of these 2 variables TRTEDT and TRTSDT.

Also an important note - custom variables for flags and dates are not being accomodated for custom labels.

For example: a custom flag variable like "PRTRNFL" with a label of "Prior Transplant Flag", or date variables such as "INITDXDT", "Initial Diagnosis Date" are not passing in version 1.4.  As a check, I tried relabeling the custom date variables to --> "Date of ..."  and it is still not passing.

If there is a restricted tolerance for differences, perhaps a Warning instead of Error makes better sense for the variable labels.

Can these tolerances be addressed?

Thank you. 
Best,

Joan

h Heli
on May 13, 2013

Thanks for starting this thread, Joan.  I am also noticing that the error is firing for...

1) our internal variables for which a label is not specified in the IG

2) TRTSDTM in a BDS even though the variable is simply being copied from ADSL with the correct label

3) AVALCATy, BASECATy and ANLzzFL even though page 13 of the ADaM IG states:

 

In general, the variable labels specified in the tables in Section 3 are required. There are only two exceptions to this rule:

(1) descriptive text is allowed at the end of the labels of variables whose names contain indexes “y” or “zz”; and

(2) asterisks (*) and ellipses (...) in specified variable labels should be replaced by the sponsor with appropriate text.

 

Thanks very much!

m Michael
on October 10, 2014

Closing the loop in case others search for this.    This was fixed in v1.4.1.   There are references to it in the public release notes.

http://svn.opencdisc.org/validator/trunk/CHANGELOG.txt

Configuration
  • Added label as magic variable replication flag (enhancement)
  • Added ability to backreference template variable name captures in labels (enhancement)
c Cathy
on April 27, 2015

Hi,

Please check - AD0018 does not fire in v1.4.1, but it is misfiring in v1.5 and 2.0 for custom variable CHGCAT1N.

m Michael
on April 27, 2015

Can you confirm that your issues for AD0018, in all versions 1.4 to 2.0, are only within scope of the CHGCAT1N variable ?

if so, i think the problem relates to this not being a standard variable in the ADaM IG.  The issue stems from our implementation of the rule and the sometimes ambiguity and "looseness" of the ADaM standard itself

We expect that any variable with CHGCAT as a prefix will have the label "Change from Baseline Category ..")

But this will pick up CHGCATy and CHGCATyN and report that the CHCGATyN has the wrong label..i assume since it has the "(N)" .   For now i can address it and add these variables explicity to the configuration.

I addressed a similar issue recently regarding AD0188 variable name: http://www.opencdisc.org/forum/ad0188-illegal-variable-name-y-not-1-9-chgcaty

Let me know if i'm on target.

Thanks.

c Cathy
on April 28, 2015

Hi,

I think you are on target.  It seems related to the fact that the prefix (in this case CHGCATy) matches an ADaM standard variable.  When I ran the same dataset in v1.4.1 I did not get AD0018 

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