ComplianceOnline

CDISC Mapping 4: SDTMs and ADAMs Examples (80%/20% Mapping Rule)

Instructor: Sunil Gupta
Product ID: 704313
  • Duration: 90 Min

recorded version

$249.00
1x Person - Unlimited viewing for 6 Months
(For multiple locations contact Customer Care)
Recorded Link and Ref. material will be available in My CO Section
Last Recorded Date: Jan-2017

Training CD / USB Drive

$299.00
One CD/USB is for usage in one location only.
(For multiple locations contact Customer Care)
CD/USB and Ref. material will be shipped within 15 business days

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Read Frequently Asked Questions

This training program 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. Through case study analysis, the course will examine best practices to provide thoughts and ideas to develop or improve the CDISC mapping system.

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 illustrate 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. Attendees will get a copy of the new CDSIC e-guide and all SAS macros reviewed in class.

Learning Objectives:

  • Utilize metadata to automatically assign variable attributes in SDTMs and ADaMs
  • Create and process ISO8601 dates, hierarchy of adverse events variables, paired lab variables, as well as lab visit window techniques
  • Apply effective techniques for using PROC TRANSPOSE to create and merge SUPPXX datasets with SDTMs to create ADAMs
  • Be better prepared for the SAS Clinical Trials Certification exam

Areas Covered in the Webinar:

  1. 80% General Variables
    1. SDTM
      • Mapping to SDTM Variables: Four Types
      • Apply One of Seven Mapping Methods
      • Eight Variable Types Based on Values
      • Control Terminology – Format Metadata from CODELISTS tab
      • SDTM Metadata Excel file
      • AE MedDRA Hierarchy Structure
      • Purpose of Trial Designs: Trial Elements, Trial Arms and Trial Visits
      • DM, AE, EX, SE, SV
    2. ADaM
      • Analysis Variables
      • Imputation Methods
      • Baseline Identification
      • Visit Windows and Unscheduled Visits
      • ADSL, ADAE
  2. 20% Special Variables
    • SDTM
      • SUPPDM, SUPPAE, RELREC
      • Questionnaire Data
      • SDTM Oncology Domains (TU, TR, RS)
      • Findings About (FA) – Collection of Different CRFs
    • ADaM - DTYPE, Other ex. ADVSLT

Who Will Benefit:

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.

  • 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. ComplianceOnline 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.

We respect feedback/opinions of our customers which enables us to improve our products and services. To contact us please email customercare@complianceonline.com call +1-888-717-2436 (Toll Free).

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