2019 - CDISC Mapping 5: ADAM Models - ADSL, BDS and ADAE
Date2019-09-18
Deadline2019-09-18
VenueOnline Event, USA - United States
KeywordsCDISC mapping training program; ADSL BDS and ADAE; ADAM metadata excel file
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
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
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- GSRD-International Conference on Robotics, Aeronautics, Mechanics and Mechatronics (ICRAMM)
- GSRD-International Conference on Medical, Pharmaceutical and Health Sciences (ICMPH)
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Last modified: 2019-07-05 21:35:45