OpenCDISC Validation Report and Dataset Labels

a Ankur

on August 18, 2015

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

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

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