ADaM

Hi,

I am getting AD0044 (*TM and its corresponding *DTM variable have different time values) and AD0045 (same but for *DT) flagging as an issue for datetime variables containing values prior to the year 1960 (i.e. where the underlying numeric value changes from a positive to negative in SAS using default options).

The data is an imputed date/time from a year of birth prior to 1960. The *DTM variable is needed to create a consistent method for the analysis requirements of the project, so although this doesn't seem useful it is a requirement we need to follow.

Using Pinnacle 21 Community Version: 3.1.0 I just re-validated ADaM data and the ADaM define.xml after updating the define.xml - the data has not changed. I received a new validation message that doesn't make sense: 

AD1012A "Secondary variable is present but its primary variable is not present" fired for "ABLF" (I assume for ABLFL/ABLFN as there is no variable "ABLF" present). I am using version 1.1 of the ADaM IG. Please see screenshot attached of "Details" tab of the P21 Community Validation Report.

Hi,

I am using Pinnacle 21 Community v3.1.0, ADaMIG 1.1, to validate ADaM datasets. Is the validation done with the most current version of CDISC ADaM Validation Check, v1.3?

Thanks,

ChuanFeng

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!