ADaM

Hi,

I am using new Pinnacle 21 2.1.0 and am getting following errors in my validator report, which I didnt have in previous versions.

Message: Variable label mismatch between dataset and ADaM standard

Pinnacle 21 ID: AD0018

Values: TRTSDT, Date of First Exposure to Treatment

Are the ADAE checks, including the use of SDTM.AE in community version 2.01

Hi,

The OCCDS provisional guide is out now. Do you have an estimate when OPEN CDISC will support the OCCDS structure?

Thanks,
Rob

Hi Sergiy,

Is IS8601DA. format is allowed in CDSIC ? I got an error in the open cdics report for *DT variables saying '* DT does not have the ADaM required SAS Date format'.

Thanks,

Sandeep

Hi, We added a variable CHGCATyN but get this error.

Thanks.

Hi, i have variable ADT (but no ADTM) in the ADAM TTE dataset but still get this error.

Thanks.

I just noticed that CDISC announced that ADaM 1.3 validation checsk were released. What is the plan for incorporating the updates in OpenCDISC community?

Hi Sergiy,

I have run adam .xpt files in open cdisc validator and all are fine except for ADCM, ADCO and ADMH. The report says with a heading 'Unporcessed Sources' and Label as 'Unknown' and Class as 'Unknown' and Reason as 'Configuration Missing'. And they are shown as 'Unrecognized Domains'. Is there any particular reason for this. Please help me out.

Thanks

There is a rule for SDTM variables needing to be in define.xml:

 

SD0060 Variable in dataset is not present in define.xml

 

I cannot find a similar rule for variables on ADaM datasets needing to be in define.xml. What am I missing?

Hi,

my question does not relate to a technical issue but is rather a question with regards to content.

We created an ADaM dataset with variables AVALC, BASEC, and ABLFL (numeric variables AVAL and BASE are not needed for the respective analysis).

Validating this dataset we receive the message 'ABLFL is present but BASE is not present', whereas the rule description is 'ABLFL is required if BASE is present in the dataset (IG page 34)'.