(Originally published on March 9, 2016. Last Updated on June 28, 2019)
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 Trevor Mankus is a co-lead of the CDISC ADaM Conformance Rules subteam with P21's Michael DiGiantomasso, Michael Beers, and Sergiy Sirichenko as active members. Between 2011 and 2018 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. Most recently, the subteam released CDISC ADaM Conformance Rules v2.0 which included support for IG 1.0 and IG 1.1.
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: A variable with a prefix of TR, containing AG with a suffix of N is present and a variable with the same root without a suffix of N is not present
P21: TRxxAGyN is present but TRxxAGy is not present
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 Conformance 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.
TIP: When validating ADaM data don't forget to include AE, DM, and EX domains for traceability checks between ADaM and SDTM data.
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.