Interpreting ADaM standards through OpenCDISC

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Author

Trupti Bal

Madhura Paranjape

ABSTRACT

Creating CDISC ADaM standard analysis datasets is a challenge. How do we make sure of the compliance for ADaM datasets before submitting it to client or regulatory agencies? Usually a lot of time is spent in performing QC of analysis datasets. Is there an efficient way to handle QC?

OpenCDISC is an open source community which provides tools to check compliance of CDISC standards such as SDTM, ADaM and define.xml. The recent addition is ADaM compliance rules. The rules included in OpenCDISC are very helpful in understanding ADaM standards.

This paper will focus on ADaM validation using OpenCDISC. Understanding OpenCDISC messages is not straight forward at times. The overview of error/warning messages will be included in the paper. Examples from real life studies will be used to explain possible resolutions for the validation messages.