ADaM

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)'.

Hi,

I have some problems with the validation rules AD0041, AD0042 and AD0043.

I validated some ADaM domains and the validator raised some format errors for all the date/time variables. I checked the formats of the variables and it seems that they are consistent with the ADaM requirements (DATE9., TIME5. and DATETIME19.)

Hereinafter I have reported an example of the error messages for the ADSL domain:

Domain|Record|Count|Variables|Values|OpenCDISC ID|Publisher ID|Message|Category|Severity

Hi,

Some studies include start or end elements with No Treatment, and the treatment starts after the first period, or it ends before the last period, at least for some Arms in the study. So TR01SDT value may be null for some subjects, or max period TRxxEDT column value may be null for some subjects.

Hi,

In one of the study, I have more than 10 criterion flag to be populated for analysis.

Now opencdisc restrict more than 9 criterion is kind of unexpected. Is there any reason to restrict with minimal criterion?

Thanks and Regards,

Saurabh 

This rule The primary variable -- is not populated but its corresponding variable -- is populated covers some variable exceptions like TRTPN. I think it's reasonable to include TRTAN like an exception. I cannot see why TRTAN can get an error but not TRTPN. Could you take a look to this issue? Thanks. Miguel

This rule 'Inconsistent value for --CAT--' is based on a few ADaM rules (221,222,224,226). All *CATy values must be the same for each unique value of the variable it categorizes within a PARAMCD. e.g. AVALCATy to AVAL. I think this rule doesn't cover a very feasible scenario: AVAL not available but AVALC populated, so it could be possible to create AVALCATy from AVALC. This scenario obviously gets an error that it should be avoided. Do you think you can do something with this issue? Thanks. Miguel

Hi, I tried to validate an ADaM compliant dataset with the using the Dataset-XML source format but got the following error: SD0062 : Incompatible data source. Does that mean that XML is not recognized? I tried with SDTM domains provided with the example package of DS-XML and it seems to work just fine. I wonder what might generate this error. I also attached the coresponding Define.xml file. Thanks Pierre

Hi am getting the follosing erros for the DTYPE variable using validator Version 1.5 for Definexml V2.0:

xpath Variables Values

Hello,

I've ran across a similar posting and I was hoping you could help me address this issue.
I still get this error in both validators, 1.4.1 and 1.5. My lab data is out to 12+ decimal places and uses average values for baseline, so CHG is super tiny. From the report below:

BASE, CHG, AVAL 11.58300018, -0.00000095, 11.58299923

Thanks,
Carol

Hi, 

I keep getting this warning when i run my checks, but i cant see any other way to do it. 

In ADEG for example, I have PARAMCD=RRMEAN, HRMEAN etc... 

Then i have several CRITx variables which are blank, or populated with CRIT1='QTcF > 450ms' or

CRIT2='QTcF increase from baseline > 30ms' for example. 

Then I get the error because some are blank and some populated within a unique PARAMCD. 

Can someone help! Or suggest another way to create these criteria variables. 

James