ADaM

Hi, 

I am trying to trigger AD0127: (BASE or BASEC is populated for a unique USUBJID,PARAMCD but no baseline record exists). And I created the following test scenario:

STUDYID    USUBJID         AVISIT     PARAMCD     BASE       ABLFL

XXXX           XXXX-1234     VISIT 1        ABCD          1,2345       <empty>        

XXXX           XXXX-1234     VISIT 2        ABCD          1,2345       <empty>  

Looking at the rule specification I would expect that this should trigger the rule:

Hi, 

I'm trying to get an overview of the different ADaM structures / classes that Pinnacle21 "recognizes" for validation.
What I've learned so far is: 

ADSL - recognized solely by the name 

BDS - Must contain at least one of the following variables: PARAMCD, PARAM, AVAL, AVALC, ADT, ASTDT, ASTDTM, CNSR, CNSDTDSC, EVNTDESC  

BDS-TTE - BDS plus presence of CNSR variable (if possible, kindly provide a list of variables as in the BDS case)

Hi team,

We'd like to validate a dataset before creating its define.xml by ourselves.

Does define.xml file automatically generated from the dataset to be checked itself also help the validation?

If so, please let me know about extra checking items to be achieved by specifing it in the Validator.

Regards,

Emi

Dear Pinnacle 21 Team,

In the new ADaM IG 1.1 the meaning for single y in a name was changed from "y is not in [1-9]" to "The lower-case letter y in a variable name (e.g., SITEGRy) ... is replaced with an integer [1-99, not zero-padded]". Therefore the following checks need an update. Please consider that the truncation of the original variable name may be necessary in rare situations when a two digit index is needed and causes the length of the variable name to exceed 8 characters (market with *).

Hi,

The error flag for AWTDIFF says "AWTDIFF is populated but AWTARGET and/or one of [ADY,ARELTM] are not both present and populated."

In one BDS dataset, we have used ASTDT, and ASTDY, instead of ADT, because we have start and end dates and the records are coming from sdtm.CE (CESTDTC, CEENDTC).  We do have values for ASTDY nonnull in these records.  (We have no column for ADY, just have ASTDY.)

Are there plans to implement Analysis Results Metadata (ARM) validation rules in Community/Enterprise versions?

n 2.0.2 we did not include these variables in BDS.  This is why you did not get the AD0018 label error when including ADSL.TRTSEQA into your BDS.    Since 2.1.0 has the TRTxxA(N) and P(N) variables in BDS, there was a conflict with the TRTSEQA and TRTSEQP

Why did we include TRTxxA(N) and P(N) into BDS in v2.1.0 ?  

Can you clarify where the validation checks AD1011/12/15/18/19 come from? Thye have publisher id's of TBD+

 

When doing an ADaM dataset validation with a define document then several datasets may not be processed due to them being ADaM "Other" or non-AdaM. Will the software always also yield SD0061 errors for each of these - Domain mention in define but does not exist?

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?