The P21 Validation Engines are consistently updated and improved upon with insights from our Subject Matter Experts, consultations with regulatory agencies, and findings submitted by our users. Examples include:

• AD1012 has been split into two rules: AD1012 and AD1012A. The former checks for custom variables and is a Warning; the later checks for standard variables and is an Error. These rules consider secondary variable names ending in *N or *C, for numeric or character equivalent, respectively.

• AD0047 was producing problems for some variables but has already been fixed and patched for over a year.

Some known software bugs will be fixed in an upcoming release. Examples include:

• SD1230 wrongly fires when value is null for value-level metadata.

• SD1231 wrongly fires for float values in value-level metadata, because it wrongly includes the decimal in the length of numeric such as AVAL.

Note: Our Validation Engines support analysis for a single study but do not yet fully support analysis for integrated studies, which may present added challenges for the ADRG.

IG, Software & Engine Versions

P21 validation rules are based on the version of the IG that you configured on the Data Package in P21 Enterprise or in the Validator screen in P21 Community.

• E.g., if you set the Configuration to ADaM-IG 1.0 or 1.1, then the rule for variable label mismatch will be based on whichever of those two versions you selected.

• Visit the Validation Rules section of our website to see rules sortable by standard, regulatory agency, and Engine version.

• Note: P21 considers the PARAMTYP variable for only ADaM-IGs 1.0 and 1.1 since it is still defined in those guidance documents. Because it was often confused with DTYPE, the PARAMTYP variable is planned to be removed in future ADaM-IG releases and thus also from future versions of our Validation Engines.

If AD0047 "Required variable is not present" fires for datasets such as ADCE, ADCM, ADMH, please explain it in the ADRG.

• This result may be due to you using an outdated version of P21 Community. Note that Pinnacle 21 has begun the End-of-Life cycle for P21 Community 2.x. Support will no longer be provided after 2021-03-31.

• Upgrade to newest version of P21Community for the most accurate validation results. Our latest release, P21 Community 3.1.0, is available via our Downloads page and offers improved functionality.

Our NMPA Engine 2010.0 now supports define.xml, SDTM, and ADaM datasets in Chinese (135 rules for define.xml, 340 rules for SDTM-IGs 3.1.3 and 3.2, and 262 rules for ADaM-IG 1.1 validation). NMPA Engine 2010.0 is currently available for P21 Enterprise users, with release to P21 Community forthcoming.

• We’ll update our NMPA Engine with more rules as CDISC Controlled Terminology, IGs, and NMPA-specific rules are released.

• Engines releases are independent of our main software releases, so you may be able to access a new Engine without needing to upgrade our main software.