AD0018 - ADaM dataset variable label mismatch

Pinnacle 21 Support ADaM
1

Hi Vankata,

Yes, it’s well known issue in v1.4. E.g., see http://www.opencdisc.org/forum/ad0018-variable-label-mismatch-validator-14

This bug was fixed in a new upcoming release of the validator.

Thank you for your findings!

Regards,

Sergiy

2

Thanks a lot

3

Hi Sergiy,

I used v1.5 and getting the same ‘annoying’ ERROR message for mismatch variable label (AD0018)

Variable label mismatch between dataset and ADaM standard

The check was fired on ANL02FL that has label Analysis Record Flag 02 (Thromb. Event)

Can you please give an update on this check.

Thank you.

Vanessa

4

Hi Vanessa,

ADaM standard requires to use exact variable labels. In your example additional text is not permitted.

“Analysis Record Flag 02 (Thromb. Event)” label should be “Analysis Record Flag 02”.

Kind Regards,

Sergiy

5

Hi Sergiy,

Thank you for your response.

Howerver, in the ADaM IG, this is listed

Additional Information about Section 3

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.

So in my case, rule (1) is acceptable right?

Thank you.

Vanessa

6

I had initially consulted Serigy about this rule and incorrectly told him that custom text was not allowed. We probably need 2 checks, 1 for variables with y and zz and another without. Should you or your team want to experiment in creating the rule, feel free to do so and contribute back the syntax to the forum. In the meantime we plan to address this in the next release.

Thank you for your patience and bringing this point to our attention.

Mike D

7

We believe this to be representative of the types of custom labels you could have

Even though TRxxPGy is allowed to have custom label, it can’t based on the standard prefix and sas variable label length limit of 40

Variable Label Example Length
TRTxxP Planned Treatment for Period xx Planned Treatment for Period 02 31
TRxxPGy Planned Pooled Treatment y for Period xx Planned Pooled Treatment 3 for Period 01 40
ANLzzFL Analysis Record Flag zz Analysis Record Flag 02 (Thromb. Event) 39
RACEGRy Pooled Race Group y Pooled Race Group Martian 25
*DTM Date/Time of … Date/time of My custom timing variable 38
8

Thank you Mike for your explanation.

Just want to clarify that custom label is allowed as long as we follow the standard way of labeling them as you had outline in the red font in the examle right?

Regards,

Vanessa

9

They are allowed according to te ADaM 1.0 IG. however the latest version of OpenCDISC will flag some of them as an error until we split the label check into 2 different checks.

10

Hi I ran version 3.0 of the tool, using IG 1.1 settings on an OCCDS dataset containing a variable ACAT1 with label “Analysis Category 1-Nature of symptoms”. The validated correctly identifies the OCCDS structure but flags the label as a warning. Has the label check not yet been splilt into 2 checks?

11

Hi Rob,

Current algorithm of AD0018 rule does not handle extensions of standard labels.

In your example, the validator still expects a label ‘Analysis Category 1’ instead of '‘Analysis Category 1-Nature of symptoms’.

Kind Regards,

Sergiy

12

Hi Sergiy,

The current P21 Enterprise version still show wrong results when adding additional text to zz or y variables. Is there a plan to update the rule?

Variable: ANL02FL
Label: “Analysis Flag 04 One Day LOCF”
Rule ID: AD0018
Message: Variable label mismatch between dataset and ADaM standard
Enterprise Version: 5.2.0

Best regards,
Matthias

13

Matthias,

Yes, we have a fix in place for AD0018. It will likely be in the next major engine release that includes new ADaM rules. It’s long overdue, so I am excited to see it finally make it’s way to production.

Also, please know that we have formal support for Enterprise customers via our Service Desk. Please use Enterprise support channels for faster responses. This forum is for Community users.

Thanks,

Trevor

14

Hi,

Why ADaM rules very strict with element labels – it’s annoying error message – cannot we change to “NOTES” instead of ERROR” message. ADaM elements creation and labels application is more subjective and user allowed to give appropriate labels as per ADaM IG rules – but I see good number of error messages in my log which does not make any sense to me – see below some examples. I appreciate your views.

VARIABLE, LABEL ANL03FL, Analysis Record Flag 03 AD0018 ADaM dataset variable label mismatch Metadata Error
VARIABLE, LABEL AP01EDT, Period 01 End Date AD0018 ADaM dataset variable label mismatch Metadata Error
VARIABLE, LABEL ANL04FL, Analysis Record Flag 04 AD0018 ADaM dataset variable label mismatch Metadata Error
VARIABLE, LABEL ANL05FL, Analysis Record Flag 05 AD0018 ADaM dataset variable label mismatch Metadata Error
VARIABLE, LABEL ANL06FL, Analysis Record Flag 06 AD0018 ADaM dataset variable label mismatch Metadata Error

Thanks,

Venkata Maguluri.