ADaM

HI,

I have a question. During the check it comes out that the variable TRTAG1 should be presented (e.g. ADLB). It is not clear to me, why this variable should be available. It is a parallel arm design and in ADLB following treatment variables are available: TRTA, TRTP. According to the guideline:

I have an ADaM define plus about 20 ADaM datasets including an ADSL.  What is needed to get rid of this rule:  skip_AD0053.

Prompt attention to this request would be appreciated...

Thanks,

-Don Hurst

Hi *,

both rules should not be counted as errors. Both variables are conditional and only required in designs with multiple treatments. 

See page 17, ADaM IG:

Hi *,

I have a question regarding the rules AD0129 - AD0130, AD0149 - AD0150. I got some errors, for e.g. ADLB, where the numerical value is not the same as the character value within the parameter. But for some parameters from e.g. URINALYSIS, numerical values are not possible.

It is stated in the guideline on page 27:

This check "When CRITy (Analysis Criterion) is populated, it's corresponding Analysis Criterion Y Flag must be populated" should be changed. Missing values are allowed if the result is missing and the Example 2 was used (see "CDISC ADaM Implementation Guide Version 1.0", page 77, Table 4.7.1.2). Please update this check.

Best regards,
Matthias

Hello,
The rule AD1008 checks for null values in required variables. Many ERRORS are printed due to missing values in TRTP where visit is SCREENING. At this time point I can't assign a planned treatment. Also in the documentation (CDISC ADaM Implementation Guide Version 1.0, page 51) an example displays missing values.
Please update this check.
Best regards,
Matthias

Which SAS format fullfill the check AD0043? (date/time format = YYYYMMDDHH:MM:SS.SS. or YYMMDD10HH:MM:SS.SS)

Hi everyone,

ADaM Validation is finally here! The newly released OpenCDISC Validator v1.2 now includes an ADaM validation rules configuration that was implemented based on the validation checks published by CDISC ADaM team available at http://www.cdisc.org/adam.

For a complete listing of ADaM validation rules supported by OpenCDISC please refer to http://www.opencdisc.org/projects/validator/cdisc-adam-1.0-validation-rules.

Thanks,
Max