Have you ever wondered how Pinnacle 21 implements rules for ADaM validation? Below is a list of commonly asked questions.
Does Pinnacle 21 implement the validation checks published by CDISC?Yes, Pinnacle 21 rules are an implementation of CDISC validation checks. In fact, P21's Michael DiGiantomasso and Sergiy Sirichenko are both active members of the CDISC ADaM Compliance subteam. Since 2011, the subteam produced 4 versions of CDISC validation checks, with Pinnacle 21 supporting the industry by releasing 7 updates to the open source rule implementations. This close collaboration between Pinnacle 21 developers, ADaM team core members, and representatives from across the industry is what makes it possible to continuously improve rule definitions and implementations.
Why do the message text and rule counts differ?
CDISC check definitions are designed to serve as requirements to machine implementation, "a programmable test, written such that an affirmative response represents a failure of the requirement. This text is intended for use as a requirement specification which could be implemented in a variety of programming languages". P21's rule messages and descriptions, on the other hand, are designed for the end user to help them quickly identify and fix the cause of validation issue.
Here is an example:
CDISC: There is more than one value of a variable with a prefix of SMQ and suffix of SCN has zz fragment appended after SMQ for a given value of a variable with a prefix of SMQ and a suffix of SC has zz fragment appended after SMQ
P21: Across studies, All SMQzzSCN must be the same for each unique value of SMQzzSC, when SMQzzSC is populated.
When it comes to rule counts, Pinnacle 21 validation engine allows many CDISC checks to be implemented as one validation rule. This significantly improves consistency across related checks and reduces the development and testing effort. In some rare cases, a single CDISC check must be implemented as multiple Pinnacle 21 rules. Regardless of the rule count mismatch, when issues are created during validation, they will always map to a singular CDISC ADaM check.
For details on how CDISC checks map to Pinnacle 21 rules, please review the following spreadsheet:
Does Pinnacle 21 implement additional rules not published by CDISC?Yes, Pinnacle 21 implements additional data quality checks for calculations, file validity, consistency between Define.xml and dataset metadata, and controlled terminology for SDTM sourced variables. There are also a few additional conformance checks found during implementation that are described in ADaM IG, but were missed in the checks specification. These are currently being reviewed by the CDISC ADaM Compliance subteam and will be included in the next rule publication. For details on additional rules, please review the "New Rules" tab in the same spreadsheet.
Are there checks Pinnacle 21 has not implemented yet?Yes, there are 16 checks which have not yet been implemented. These rules require validation engine enhancements planned for later this year. For details on additional rules, please review the "Not Implemented" tab in the same spreadsheet.
How do CDISC checks compare to the validation rules published by PMDA?PMDA published validation rules, just like Pinnacle 21 rules, are designed for the end user, while CDISC checks are for machine implementation. This is why the PMDA specification uses Pinnacle 21 messages and descriptions. This also means that by virtue of Pinnacle 21 implementing CDISC checks, PMDA rules also implement CDISC compliance requirements. The only difference is that PMDA uses different Severity for some rules. While CDISC defines all checks as "Error", PMDA changed some to either "Warning" or "Reject" to meet their regulatory review requirements. For details on how PMDA rules map to CDISC checks, please review the "CDISC to P21 to PMDA" tab in the same spreadsheet.
What is the difference in ADaM validation between Pinnacle 21 Community and Enterprise?Pinnacle 21 Community and Enterprise both implement exactly the same ADaM validation rules, which means that all end users (Community or Enterprise) will see the same validation issues.
If you are interested in validation check development, it's not too late to get involved. With ADaM IG v1.1 just released, the CDISC ADaM Compliance subteam could use your help. Also, if you find any issues with the current rule implementations or have ideas on how we can improve Pinnacle 21 software, please write to us on our Forum.