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Ref : 29604
Event :Cdisc Mapping 5: Adam Models - Adsl, Bds and Adae

Date :Wednesday August 21st, 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 session 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. The program will provide effective and practical solutions to address real-world issues

Objectives

  • Utilize metadata to automatically assign variable attributes in ADaMs
  • Create and process ISO8601 dates, hierarchy of adverse events variables
  • Better understand the purpose of running OpenCDISC
  • Submit better FDA submissions by better understanding the technical and process review

Program

  • ADAM Metadata Excel File
  • ISO8601 Dates, Partial Dates, Durations and Periods
  • Study Validation Checklists
  • SDTM and ADaM QC Forms
  • OpenCDISC and SAS Clinical Standard Toolkit
  • Templates – SDTM and ADaM Specifications, Defaults, Master SDTM to ADaM Map
  • ISS/ISE – Master Control Terminology
  • Understanding the FDA Review Process and Preventing Delays - FDA’s High Expectations
  • Understanding How to Avoid FDA Review Issues – Challenges
  • Sponsor’s Best Practices for Better FDA Submissions - Lessons Learned

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

Map and directions
Conference address :
Palo Alto
2479 East Bayshore Road,
Suite 200
94303 Palo Alto
United States
tel : +1-888-717-2436
Map and directions

Further information

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Details

Cdisc Mapping 5: Adam Models - Adsl, Bds and Adae Hospital - Research
cdisc mapping training program, adsl bds and adae, opencdisc, adam metadata excel file, iss ise master control terminology
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
10 -- --
English

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