CDISC Mapping and Strategies Implemented

CDISC requirements to create SDTMs and ADaMs are not easy to understand or apply. There are many rules and standards that must be mastered and maintained across global studies. Pharmaceutical companies and CROs supporting global studies have a need to apply proven methods that reduce confusion and improve documentation. With new members joining the study team, there should be a system to help standardize and automate the FDA submission process.

Learning Objective:

Upon completing this course participants should:

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

Understand key differences between SDTM and ADaM Models and Process Flows

Understand key differences between the Seven CDISC Classes

How to create Dataset.XML from SAS

Better understand structure and syntax of ODM-XML files using 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

Note:

Use coupon code NB5SQH8N and get 10% off on registration.

For Registration:

http://www.complianceonline.com/cdisc-mapping-sdtm-adam-models-sas-odm-xml-seminar-training-80337SEM-prdsm?channel=sciencedz