Module 12 2019

AGENDA TOPICS

❑ Data Governance

❑ Background, History and Legal Basis ❑ Electronic Data Capture (EDC) ❑ Data Input/Output ❑ Data Querying ❑ Data Management Plans

❑ Data Standards

❑ Regulatory Involvement in Data Management and Data Governance (DM/DG)

Workshop/Activity

The Organisation for Professionals in Regulatory Affairs