Automated Case Report Form Validation

Each CRF created by any tool must be completely validated prior to going live. This is a very tedious and labor intensive task requiring hundreds of human resource hours. Each form must be tested for database validity, edit check accuracy and a variety of other things. Each test must be thoroughly documented. The documentation must be easily searchable and indexed by potential auditors. Every possible combination of data must be tested and retested prior to tagging a form validated.

Crucial Life Sciences has invented a technology that completely automates this process. It does so in such a way that the system emulates 100% of the actions made by a user when completing a Case Report Form, a requirement for true CRF validation. In addition, the test data run through the form is created automatically. All of the automatically created test scripts are editable by the study designer.

Automatic Test Script Creation
Automatic Test Script Creation

However, it goes beyond that: because Clinical Studio is a single system, each application is fully cognizant of every other application. When creating test data, the system knows the possible combinations of numeric and coded fields. We also know each and every edit check that is in place. When Clinical Studio creates a test script it does so in such a way that each combination of data is tested and every edit check is fired in the process. Along the way, the system documents everything in a highly sophisticated data model that can be easily searched, filtered and presented to any auditor who may be interested. Those same validation results can then be exported to an Excel spreadsheet and archived.

Auto-validating the Form with the Test Data
Auto-validating the Form with the Test Data

 

Comprehensive, Searchable Results Log
Comprehensive, Searchable Results Log

All form versions contain the validated tag as separate entities. Protocol versioning is built directly into the auto-validation.

Form Validated Tag
Form Validated Tag