ADaM

Description

Technical support questions about ADaM standard and validation rules

March 3, 2011

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:

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February 4, 2011

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

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February 4, 2011

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

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February 3, 2011

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

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January 25, 2011

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

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