Variable label mismatch between dataset and ADaM standard - AD0018

Correct

Those do look right.  Are you sure you don't have any hiddent trailing characters in the labels ?   Also, can you send me your file so i can test with it?  You can remove all the data, just leave 1 row.

File request

You can send to mike@opencdisc.org.   I will look at it promptly

Remove placeholder timing variable labels

In 2.1.0, the ADaM 1.0 IG Placeholder variables were accidentally reintroduced into the document which is used for validation.   The problem sometimes comes down to process and process change in general.  In the past, labels were called labels.  Now they are callled Description/TranslatedText.   Since we maintain a faithful representation of the standards that are merged with validation logic, these labels were accidetnally put back in which makes sense for the IG, but not when trying to validate.   Remove them in th ADaM IG 10.xml and you will not have these issues anymore.

            <ItemDef OID="IT.BDS.*DTM" Name="*DTM" DataType="integer">

                <Description>

                    <TranslatedText xml:lang="en">Date/Time of ...</TranslatedText>

                </Description>

            </ItemDef>

Removing elements

I noticed in the XML for the affected <ItemDef> elements that some had <CodeListRef> elements.  For example:

  <ItemDef OID="IT.BDS.*EDTF" Name="*EDTF" DataType="text">

      <Description>

          <TranslatedText xml:lang="en">End Date Imputation Flag of ...</TranslatedText>

      </Description> 

      <CodeListRef CodeListOID="CL.C81223.DATEFL"/> 

  </ItemDef>

Please do not remove any elements, only data

Change this

<TranslatedText xml:lang="en">End Date Imputation Flag of ...</TranslatedText>

to this

<TranslatedText xml:lang="en"></TranslatedText>

Next version of Pinnacle Community will fix this.

Further problems with AD0018 check

Hi Mike,

After applying the changes, we are also getting some issues for the following variables:

TRTSEQP - Planned Sequence of Treatments

TRTSEQPN - Planned Sequence of Treatments (N)

TRTSEQA - Actual Sequence of Treatments

TRTSEQAN - Actual Sequence of Treatments (N)

I checked the labels and they seem fine. I even went as far as cutting and pasting the exact text from the configuration file and I still get the same results however I don't get this issue if I run against v2.0.2.

Is this a known problem and are we able to amend the configuration to suppress?

Thanks

Steve

Can you send me your sas .xpt

Can you send me your sas .xpt file with the bad labels.   You can just include 1 row.

ADSL variables included in BDS for analysis

Your dataset AD0018.xpt is recognized as BDS.
The 4 variables below are reserved ADSL variables names.  
They are compared against BDS variables of form TRTxxP(N) and TRTxxA(N).
The validator says, “the stuff in between TRT and P, "SEQ", is not IN  [01,...99].   Therefore fail.”  

Immediate easy work around which is true to the open source community model.   

1.  open your components\config\ADaM 1.0.xml
2. Seach for any variable that exists in ADSL, that you want in BDS (if not already there) as in: <ItemRef
 ItemOID="IT.ADSL.TRTSEQP" OrderNumber="35" Mandatory="No" Role="Treatment" val:Core="Conditional"/>
3. Copy the line above and paste it as the last ItemRef in BDS.  Optionally change the orderNumber, but it probably doesn’t matter.  Rerun and watch your AD0018 go away !

Long term solution (for Pinnacle)

1.) explicity assign every ADSL variable in BDS - can be immediately done with metadata
2.) inspect ADSL variables when validating BDS variable metadata.  Requires software change

AP01SDT possibly being compared to *SDT

Rob, for this one, you may also be experiencing the issue where it is comparing it to *SDT.  Make sure you remove those labels and rerun.   AP01SDT should only be in ADSL dataset.

Inclusion of ADSL TRTxxP(N) and TRTxxA(N) into BDS in 2.1.0

In 2.0.2 we did not include these variables in BDS.  This is why you did not get the error when including ADSL.TRTSEQA into your BDS.    Since 2.1.0 has the TRTxxA(N) and P(N) variables are in BDS there was a conflict with the TRTSEQA and TRTSEQP

Why did we include TRTxxA(N) and P(N) into BDS in versions in 2.1.0 ?  

1. the ADaM IG 1.0 TTE explicity includes them as time to event variables.  
2. ADaM IG 1.0 says "for BDS that TRTxxP (copied from ADSL) may also be needed for some analysis purposes, and may be useful for traceability and to provide context"
3. The ADaM IG 1.0 p20 says that any ADSL variable may be copied to BDS.  

check AD0018 incorrectly reports an error

Hi,

The check AD0018 incorrectly reports an error. We use corresponding numerical code variables for the CRITy variables, called CRITyN with label “Analysis Criterion y (N)”. This corresponding numerical variable concept is compliant with the ADaM rules and therefore no issue should be reported.

Example:

CRIT1=”Decrease of >= 20% from baseline”
CRIT1N=3
CRIT1FL=”N”
CRIT1FN=0

Could you update this check to allow corresponding numerical variables which using “* (N)” as Label?

AD0018 ANL01fl Variable label mismatch

Hi,

We are getting Variable label mismatch errors for ANL01FL, ANL02FL variables. The label is as per IG. I assume it is the same problem as described above?

Thanks,

Rob

Fixed yet for TRTSEQP / N, TRTSEQA /N in the BDS config?

Hi Mike,

Is there a plan to be adding this to the BDS configuration? People are reporting to me they are getting the AD0018 error for these 4 labels.

Thanks,

Joan