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2019 - CDISC Mapping 5: ADAM Models - ADSL, BDS and ADAE

Date2019-09-18

Deadline2019-09-18

VenueOnline Event, USA - United States USA - United States

KeywordsCDISC mapping training program; ADSL BDS and ADAE; OpenCDISC

Websitehttps://www.complianceonline.com/cdisc-m...

Topics/Call fo Papers

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

Last modified: 2019-05-30 21:52:02