CDISC/Pinnacle21

Course Overview

This course focuses on the use of Pinnacle 21 (P21) — the industry-standard validation tool used to check SDTM, ADaM, and Define.xml datasets for regulatory compliance. You’ll learn to interpret validation reports, fix compliance issues, and prepare submission-ready datasets that meet FDA and PMDA requirements.

Learning Objectives

• Understand the purpose and architecture of Pinnacle 21.

• Perform dataset validation for SDTM, ADaM, and Define.xml files.

• Interpret validation reports and identify key compliance issues.

• Resolve validation warnings and errors efficiently.

• Ensure datasets are CDISC-compliant and submission-ready.

• Differentiate between P21 Community and Enterprise versions.

Course Modules

Module 1: Introduction to Pinnacle 21

• Overview of P21 and its role in CDISC validation

• P21 Community vs Enterprise

• Integration with SAS and Define.xml tools

Module 2: Validation Rules and Controlled Terminology

• Understanding FDA and PMDA validation rules

• Controlled terminology management

• Common issues in SDTM and ADaM validation

Module 3: Running Validation

• Setting up validation projects

• Running checks for SDTM and ADaM datasets

• Reviewing validation summaries and detailed outputs

Module 4: Interpreting Validation Reports

• Understanding error categories: Error, Warning, and Notice

• Mapping messages to CDISC standards

• Prioritizing and fixing critical validation findings

Module 5: Define.xml Consistency and Compliance

• Linking datasets and metadata in Define.xml

• Validation of variable attributes and derivations

• Ensuring traceability and consistency between datasets

Module 6: Submission Readiness and Best Practices

• Pre-submission validation workflows

• Handling Enterprise-level compliance dashboards

• Preparing data packages for regulatory submission

Key Features

• 💻 Hands-on practice with Pinnacle 21 Community

• 📊 Real-world examples of validation findings

• 📘 Coverage of both SDTM and ADaM datasets

• ✅ FDA & PMDA submission readiness guidance

Who Should Attend

• Clinical SAS programmers and CDISC specialists

• Data managers and submission analysts

• Biostatistics and regulatory affairs professionals

• Anyone working on CDISC-compliant data pipelines

Duration

Approx. 6–8 hours (including practical validation exercises)

What You’ll Gain

By the end of this course, you will be able to perform full dataset validation using Pinnacle 21, interpret validation results, and ensure that your SDTM, ADaM, and Define.xml files meet CDISC and regulatory submission requirements.