CDISC Validation Rules Repository

If you have ever been tasked with creating or validating CDISC datasets, then you know that it’s not an easy job. You know it takes hours of studying the data models and implementation guides, reviewing specifications, digging through the CDISC forum, trying to derive all the business rules. You’ve probably also wished for a clear and concise list of all the validation rules for each standard. You’re not alone, OpenCDISC feels the same way, that’s why we created the Validation Rules Repository. We pool together the knowledge and resources of the CDISC community to produce a central listing of validation rules for each standard. The Validation Rules Repository is open to the entire community to use, contribute, improve, and develop further. Rules for the following standards are already available:

• SDTM 3.1.2
• SDTM 3.1.1
• Define.xml 1.0

We are also currently working on drafts for the following:

• ADaM 1.0
• SEND 3.0

Also, here is the research comparing WebSDM rules to SDTM specification as presented by Sergiy Sirichenko of PAREXEL at the CDISC Interchange Europe 2010:

• WebSDM rules to SDTM specification references

Please contribute by commenting on the rules or suggesting new rules on our forum.