ADaM

Hi!

When the ADaM 1.1 checks are out for the community, will there also be a cross check between ADaM and SDTM? The ADaM validation rules require DM, EX, and AE for some checks, but no errors are thrown out if you don't include the SDTM datasets. Is this because of the community version of Pinnacle?

Thank you in advance!

i have a question on treatment variables in adsl. lets say if some subjects are randomized to treatment A and others 

to control group. Later in the study the same control group subjects are given treatment A dose , So in  ADSL do we need to use trtseqx variables along with trtxp, trtxa or is there any better way. 

thks,

neha

Hi,

I received some ADaM datasets, and Pinnacle is throwing the AD0043 error in every dataset.  It turns out that the DTM variables were formatted as "IS8601DT."  I checked the TERMS attribute of the AD0043 rule, and I saw "E8601DT" is valid, which IS8601DT is an alias for.  Is this a false positive, and could the rule be extended to include aliases?

I goe this error message when i tried to validate ADaM datasets:

ID:              AD0053   

Message:    USUBJID value does not exist in the SDTM DM domain     

Description: Unique subject identifier not found in the SDTM Demographics domain. There must be traceability between ADaM and SDTM.

For the above error messsage, why it is generated? Or more general, how OpenCDISC check the traceability between ADaM and SDTM datasets?

Hi,

I am getting the label mismatch error for variable "TRTSEQP", for label='Planned Sequence of Treatments' and "TRTSEQPN" , label='Planned Sequence of Treatments (N)' for ADVS. These variables are created as per ADaM IG 1.0.  Could you please explain why I am getting these mismatch errors, am I missing on anything?

Thanks,

Snehal

Dear sir/madam,

I noticed in the ADaM 1.0.xml configuration file that validation rule AD0018 is not active for the ADAE domain .

Could you fix this by adding the rule in the upcoming version of the config files, cfr below?

Hi,

I noticed there were no P21 issues for non-ascii characters in ADaM datasets. Do you know if non-ascii characters are allowed for ADaM? There are issues that appear in P21 if non-ascii chars are present in SDTM datasets. I am wondering why none are added for ADaM.

Thanks.

one of the study, ADCM dataset has values other than "Y","N", null for TRTFL and TRTFLN but pinnacle21 2.2.0 is not flagging this issue, its working for other domains. 

please can you advice.

Hi,

Dear all,

We recently noticed that rule AD1012 doesn't fire as expected.
For example, no issue is reported when only the numeric (secondary) variable of following variable pairs is present in a BDS dataset:
BMIGR1(N), REGION1(N), TSEQPG1(N), and RACEGR1(N).