ComplianceOnline

CDISC Mapping 1: Specifications and FDA Requirements

Instructor: Sunil Gupta
Product ID: 704152
  • Duration: 90 Min

recorded version

$249.00
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Recorded Link and Ref. material will be available in My CO Section

Training CD

$299.00
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CD and Ref. material will be shipped within 15 business days

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Read Frequently Asked Questions

This training program will discuss CDISC requirements to create SDTMs and ADaMs. It will also offer essential mapping and strategy concepts for creating and validating SDTM and ADaM variables in key CDISC datasets (DM, AE, ADSL, and ADAE).

Why Should You Attend:

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.

This webinar will instruct attendees on essential mapping and strategy concepts for creating and validating SDTM and ADaM variables in key CDISC datasets (DM, AE, ADSL, and ADAE). Examples of both SDTM and ADaM dataset structures will be reviewed and compared. In addition, a mapping plan from raw datasets to SDTM to ADaM datasets will also be outlined.

To help assure higher quality clinical data, a QC checklist and some key edit check macros will be introduced. Participants will also get a copy of the new CDSIC e-guide and all SAS macros will be reviewed. Through case study analysis, the course will examine best practices to provide thoughts and ideas to develop or improve the CDISC mapping system.

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

Instructor Profile:

Sunil Gupta is an international speaker, best-selling SAS author, and a global corporate trainer. He is the principal SAS/CDISC consultant at Gupta Programming since 1994. Most recently, he taught both of his CDISC online classes with the University of California at San Diego and SAS Institute India. Mr. Gupta will start to teach the new Sharpening Your SAS Skills online class for UCLA Extension in 2016. In 2011, he launched his unique SAS resource blog, SASSavvy.com, for smarter SAS searches. Currently, SAS Savvy’s membership consists mostly of SAS programmers, university students and pharmaceutical corporate accounts.

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