a Ankur
on

 

Hello,

I have a question regarding the labels for the ADaM datasets. When we run the OpenCDISC validation on the SDTM datasets, report generated shows column as Domain (with name) and Label (with SDTM datasets label) as shown in the screenshot (1) below but same is not true for ADaM datasets OpenCDISC report, ADaM report shows the domain name and in label it shows the class information instead of labels assigned by me, please see screenshot (2) for ADaM report.

Am I making any mistake here? or we have an explanation here such as labels for ADaM are basically assigned based on sponsor's discretion and not specifically assigned by ADaM guidelines etc.?

(1)

Domain            Label

AE                  Adverse Events

DM                 Demographics

DS                  Disposition

EG                  ECG Test Results

 

(2)

ADAE              Basic Data Structure

ADCM             Basic Data Structure

ADSL              Subject-Level Analysis

 

Thanks for clarification in advance.

Regards,

 

Ankur

Forums: General Discussion

s Sergiy
on August 20, 2015

Hi Ankur, 

There is confusion between analysis dataset Class and Labels.

Your example refers to ADaM dataset Class. In Tabulation datasets Class values are FINDINGS, EVENTS, SPECIAL PURPOSE, etc.

Analysis dataset labels should be descriptive, unique within study (including SDTM data). Some examples are

 

  • ADAE - "Analysis Adverse Events" or "Adverse Events Analysis Dataset"
  • ADCM - "Analysis Concomitant Medication" or "Concomitant Medication Analysis Dataset"
  • ADSL - "Analysis Subject Level" or "Subject-Level Analysis Dataset"

 

Kind Regards, 

Sergiy

 

a Ankur
on August 20, 2015

Hi Sergey,

This is how labels are appearing in ADaM OpenCDISC report for column label. I have checked the contents and all datasets have appropriate labels and transport files are based on those sas datasets only but when I run the OpenCDISC report ADaM dataset label column shows information about "Class" and "Class" column appropriately describe its values as Basic Data Structure or Subject-Level.

Please advise,

 

Thanks,

Regards,

 

Ankur

s Sergiy
on August 20, 2015

Sorry Ankur, 

I cannot reproduce your case. My validation report for ADaM includes actual dataset labels in Label column.

What version of OpenCDISC Community are you using?

Thanks,

Sergiy 

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