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