Open Cdisc Report

Background Story:
Once my boss asked me to review an Open CDISC report for SDTM dataset packages. I wasn’t sure what to do at first. With the help of my colleagues, I gradually develop a sense of how to review the CDISC report.

I’d like to share some review processes and common Open CDISC Summary from PINNACLE21.

OPEN CDISC Format: Excel sheet including Dataset Summary, Issue Summary, Details, Rules, and General information such as Configuration, Define.xml, Generated Date, Engine Version, MedDRA Version 23.1, Terminology Version.

Dataset Summary: Including Processed Sources, Domain, Label, Class, Source, Records number, Errors, Warnings, Notice.

Issue Summary: Including Source dataset, Rule ID, Message, Severity, Found, Explanation.

We are focusing on explaining the item has Severity equals to Error or Warning

For example, 

Rule IDMessageSeverity Explanation
SD1082variable length is too long for actual dataErrorCompany x have defined fixed length for standard variable cross the domain.
SD0013xSTDTC is after xENDTCErrorData Issue, subjid=xxx, reported to DM
SD1117
SD1201
Duplicate RecordsWarningxSPID is used for unique records

For records xStart Date is after xEnd Date, we will check in the Raw Data Level to identify the subject and event level.

We can also cross-check with other datasets to see if similar issues happen multiple times.

Details: List the severity messages with respect to Variable values, records numbers. 

Rule: Describe each Rule ID and their belonging Categories (Terminology, Presence, Format, Consistency, Limit)

Happy Studying!

 

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