CDISC Mapping 5: ADAM Models - ADSL, BDS and ADAE

Description

CDISC Mapping 5: ADAM Models - ADSL, BDS and ADAE is a webinar that covers topics such as:

  • Iso8601 dates, partial dates, durations and periods
  • Adam metadata excel file
  • Sdtm and adam qc forms
  • Study validation checklists
  • Templates – sdtm and adam specifications, defaults, master sdtm to adam map
  • Opencdisc and sas clinical standard toolkit
  • Understanding the fda review process and preventing delays - fda’s high expectations
  • Iss/ise – master control terminology
  • Sponsor’s best practices for better fda submissions - lessons learned
  • Understanding how to avoid fda review issues – challenges

CDISC Mapping 5: ADAM Models - ADSL, BDS and ADAE is intended for professionals in the pharmaceutical, biotechnology and medical device industries, including:

  • Quality Assurance Specialists
  • SAS Statistical Programmers
  • Medical Writers
  • SAS Statistical Managers
  • Regulatory Affairs Associates
  • Statisticians
  • Directors, Statistical Programming
  • Clinical Data Managers
  • Health Care Professionals
  • CRO Professionals
  • Research University Specialists

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Important

Please, check the official conference website for possible changes, before you make any traveling arrangements

Prices are for evaluation only.

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