FDA Review and CDISC Data and Metadata Standards

Presented: Thursday, June 28th

Speaker: Joel Hoffman, Insightful Corporation

Listen to the on-demand web cast. Download instructions on how to view the web cast.

Download the web cast presentation.

For many Europeans, FDA’s New Drug Application review processes and requirements are confusing and worrisome. The submission of data has lead to misconceptions like FDA will not accept S-PLUS analysis and output or that datasets must be generated as a separate parallel process with the production of submission output. Yet we know that neither is true. FDA has always accepted S-PLUS analyses and output (as well as output from any other quality validated system) and that submission datasets can add significant efficiencies to the analysis and reporting process.

In this Web cast we will use FDA presentations and results from the recent FDA / CDISC Pilot Submission to describe the FDA review priorities and how CDISC Data and Metadata standards can be used to in the submission process.

We will demonstrate the use of these standards for automating the submission process and suggest ways in which the end-to-end trial process can be enhanced by standards with a particular focus on:

• Using metadata for specification, execution, documentation
• Generating Analysis data sets automatically
• Harmonizing submission and operational information needs