Description
This course covers the international Guideline ICH E2A, which relates to Clinical Safety Data Management. Sections include a review of ICH and an introduction to ICH E2A; Definitions and Terminology related to the clinical safety experience; standards for expedited reporting; reporting time frame, the procedures for reporting, managing blinded therapy cases, miscellaneous issues, and informing Ethics Committees and Investigators; and Quality Management Systems.
This course can be used alone or as part of the full curriculum.
