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Event :CDISC Mapping 3: Compare and Contrast SDTM and ADaM Steps

Date :Wednesday April 24th, 2019

Location :Palo Alto
2479 East Bayshore Road,
Suite 200
94303 Palo Alto, United States

Type :Conference & Seminar - International audience

Accreditation :--


 

Further information

Editorial

This training program will assist 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 training. Effective and practical solutions to address real-world issues will be detailed

Objectives

  • Utilize metadata to automatically assign variable attributes in SDTMs and ADaMs
  • Understand the differences between the four different variable roles and three different variable types
  • Better understand the nine steps to SDTM mapping and seven steps to ADaM mapping
  • Better understand raw data, dataset joins and traceability concepts

Program

hy 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 enumerate 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 receive a copy of the new CDSIC e-guide and all SAS macros reviewed in class. 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:

  • Utilize metadata to automatically assign variable attributes in SDTMs and ADaMs
  • Understand the differences between the four different variable roles and three different variable types
  • Better understand the nine steps to SDTM mapping and seven steps to ADaM mapping
  • Better understand raw data, dataset joins and traceability concepts
 

Areas Covered in the Webinar:

  • Compare SDTM and ADaM – Key Differences
  • When are Key SDTM/ADaM Variables Created
  • Mapping Raw Data to SDTMs by SDTMs
  • Nine Step SDTM Mapping Plan
    • Confirm Date Variables
    • SDTM Mapping of Study Day, ex AESTDY
    • Three Types of Raw Data Collected
    • Three Types of Dataset Joins
    • Match DM Variables: Three Types of Raw Variable Mapping to SDTMs
  • Seven Step ADaM Mapping Plan
    • ADaM Model Concepts
    • ADaM Six Levels of Flag Variables
    • ADaM BDS Variable Types
    • Three ADaM Models
    • Traceability
    • ADaM Mapping Plan – Analysis visit windows
    • ADLB – DTYPE=‘XXX’ New Records

Speakers

Sunil Gupta

Sunil Gupta
SAS Global Forum Conference Presenter Mentor, SAS

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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Location

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Conference address :
Palo Alto
2479 East Bayshore Road,
Suite 200
94303 Palo Alto
United States
tel : +1-888-717-2436
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CDISC Mapping 3: Compare and Contrast SDTM and ADaM Steps Management
cdisc mapping training program, sdtm and adam, sdtm and adam mapping, types of dataset joins, dm variables"
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
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