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

Topics

• 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

Who should Attend

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