Invalid Class value

p Priyanka

on May 2, 2019

Hi,

What should be the Class value for ADAE dataset. I have given OCCURRENCE DATA STRUCTURE and getting an error(DD0055,Invalid Class value) in pinnacle report.

Kindly provide your comments.

Thanks in advance!!

Forums: ADaM

s Sergiy

on May 2, 2019

ADaM IG 1.0 does not have OCCDS class. It was added in later ver

Hi Priyanka,

You can find DD0055 rule description on the last tab of your validation report or on Pinnacle 21 website. https://www.pinnacle21.com/validation-rules/define-xml

DD0055: "The Class attribute must have a value of 'SPECIAL PURPOSE', 'FINDINGS', 'EVENTS', 'INTERVENTIONS', 'TRIAL DESIGN', or 'RELATIONSHIP' for SDTM and SEND data and 'SUBJECT LEVEL ANALYSIS DATASET', 'BASIC DATA STRUCTURE', or 'ADAM OTHER' for ADaM data."

Community 2.2.0 supports only ADaM IG which is limited to ADSL and BDS.

Occurrence data structure was introduced in later version ADaM IG 1.1. Therefore in terms of ADaM IG 1.0, ADAE and other OCCDS datasets are formally considered as "ADAM OTHER".

Kind Regards,

Sergiy

P.S. Supplemental IG for ADAE classified this dataset as provisional Class "ADAE". However, it has been ever promoted to a standard class and is considered as a part of Occurrence Data Structure now. There are some discussions within CDISC teams about adding new Element Subclass. It would allow to specify ADAE as a subclass of OCCDS class