December 2020

CDISC ADaM Validation with P21

December 1, 2020

P21 Validation Engine Improvements

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.