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; OpenCDISC
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
Other CFPs
- Writing Effective SOPs for the Medical Device and Pharmaceutical Industries
- Good Documentation Practice (GDocP) for FDA Regulated Industry
- Fired by Facebook - HIPAA and social media violations of HIPAA’s privacy requirements
- Live Webinar A Bulletproof, Cost-Efficient Supplier Management Program
- Adjustable Rate Mortgage (ARM) Rule
Last modified: 2019-05-30 21:52:02