CDISC Mapping 1: Specifications and FDA Requirements

Learning Objectives:

• Better understand ODM and SDM models
• Better understand how SDTM and ADaM metadata play an important role to automate the process
• Know how to maintain control terminology and value level metadata
• Better understand differences and purpose of DEFINE.XML and DEFINE.PDF

Areas Covered in the Webinar:

• Understanding CDISC Terms
• ODM and SDM Map – The Big Picture
• CDASH, Study Data Standardization Plan and Submission Data Standards
• SDTMs and ADaMs Specifications
• Metadata Files and Control Terminology
• CDISC Reference and Guides
• DEFINE.XML and DEFINE.PDF – Differences and Examples

Who Will Benefit:

This course is intended for anyone directly or indirectly responsible for the creation, content or validation of CDISC data sets, tables, and data lists used to support research, drug or medical device efficacy and safety in a regulatory submission. Professionals in the pharmaceutical, biotechnology and medical device industries who want to be Good Clinical Practices (GCP) compliant in relation to regulatory submission environment will benefit from this unique course. Effective and practical solutions to address real-world issues will be provided.

This course is recommended for:

• SAS Statistical Programmers
• Quality Assurance Specialists
• SAS Statistical Managers
• Medical Writers
• Statisticians
• Regulatory Affairs Associates
• Clinical Data Managers
• Directors, Statistical Programming
• CRO Professionals
• Health Care Professionals
• Research University Specialists