A Strategy for Dealing with Pinnacle 21 Errors and Warnings

Carey Smoak
S-Cubed


Abstract

Pinnacle 21 is a widely used tool for evaluating SDTM and ADaM datasets that are to be submitted to regulatory authorities (FDA and PMDA) for approval of a drug or biologic product. Pinnacle 21 evaluates these SDTM and ADaM datatsets against published validation rules and produces a spreadsheet listing errors and warnings based on the validation rules. Have you ever wondered how to deal with all the errors and warnings that are found in a Pinnacle 21 report? In this Hands On Workshop you will learn a strategy for annotating Pinnacle 21 Reports to help you keep track of the types of errors and warnings that Pinnacle 21 produces. Attendees in this Hands On Workshop will learn practical steps for annotating a Pinnacle 21 Report to deal with the types of errors and warnings.