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CDISC Mapping 3: Compare and Contrast SDTM and ADaM Steps

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.

$999.00
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rec Recorded Link and Ref. material will be available in My Account Section
Last Recorded Date: Nov-2015

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(PPT + Recorded Training File)

$399.00
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(For multiple locations contact Customer Care)
Downloadable link along with the materials will be emailed within 2 business days
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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
Who Will Benefit:
  • 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 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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Refund Policy

Registrants may cancel up to two working days prior to the course start date and will receive a letter of credit to be used towards a future course up to one year from date of issuance. FDATrainingAlert would process/provide refund if the Live Webinar has been cancelled. The attendee could choose between the recorded version of the webinar or refund for any cancelled webinar. Refunds will not be given to participants who do not show up for the webinar. On-Demand Recordings can be requested in exchange.

Webinar may be cancelled due to lack of enrolment or unavoidable factors. Registrants will be notified 24hours in advance if a cancellation occurs. Substitutions can happen any time.

If you have any concern about the content of the webinar and not satisfied please contact us at below email or by call mentioning your feedback for resolution of the matter.

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