ADaM

For the “data fitness scorecard overall score”, could I ask how are the “Overall Score” decided by each of the ADaM Compliance, controlled terminology, etc.

I have a question for the P21E “Issues by Treatment report”, for validating ADAM item11 package validation. From the reported value, it seems to display by the ADSL.ACTARMCD or DM.ACTARMCD.

But the frequencies are not exactly the same as the ADSL.ACTARMCD or DM.ACTARMCD. Please see the difference between the P21E reports and the ADSL.ACTARMCD frequencies below. Is there any reason why the frequencies do not completely match? Thank you. 

Hello,

I just started to use P21 V3.0.2 to check ADaM datasets. I have two questions on CDISC validation rules versions.

1. Whether P21 V3.0.2 did support validation rules up to ADaM Conformance Rules V2.0 ? I think so. I just  read the article "Introducing P21 Community 3.0".

2. Has P21 V3.1.0 engine included ADaM Conformance Rules V3.0 ?

Thanks,

Ying

Hello,

As you know SDTMIG v3.3 states ARM should be null if no arm is assigned, for example screen failures, but when we carried over ARM into ADSL, AD0196 fired, complaining ARM is null. 

Thanks.

Hi all, 

We have received the following warning messages on a few subjects when run P21 to check ADSL. We have cross checked the two data sources and it appears that there're actually matching. We have also verified that the attributes for the 3 variables are match as well. Do you happened to know why we're getting this message? 

For the same USUBJID, the ADSL.AGE != DM.AGE

For the same USUBJID, the ADSL.RACE != DM.RACE

Hi Team,

we are trying to run Pinnacle on ADaM data set and each time we are getting different count for same error and also counts are not matching between "issue summary" and "Details".

Thanks,

Karan

Hi, 

When I read datasets into P21 for validation, I noticed that no rules have been established for checking the following variables in ADaM: DTYPE, SRCVAR, SRCDOM, SRCSEQ. Am I missing something? Will there be rules established for checking these variables? If so, when?

Thank you in advance for your time!

Hi, 

I'm getting this error message why reading data into Pinnical 21. I only have BASEC populated as I have a categorical response for the given PARAMCD. and I made sure I have the same value for BASEC for the given category. Can anyone please let me know what the problem is here?

Thank you very much!

Hi,

According to the ADaMIG, SRCSEQ is supposed to be a numeric field.  However, we recently ran P21E conformance checks on an ADaM dataset where SRCSEQ had been incorrectly defined as a text field (and actually contained concatenated strings of sequence numbers), and nothing was flagged as either an error or a warning.  Is this planned as a future check?

Thanks,

    Nancy

Hi,

Could you please tell me what is happened for AD0033 - AD0036 rules?
Or in which scenario rules (AD0033 - AD0036) will work in Pinnacle21 validator.

Here is one example of AD0034 case. This situation is occurred for many CRT packages and I think this example is also happened in other company.

Dataset;
> 20 ADaM datasets with BDS and ADaM Other (+ define.xml). All ADaM datasets have ESPFL variable with Y/N terminology.