Learning Objectives:
Tools Provided: CDISC User Standards, ALCOA Attributes Checklist, applicable regulation and guidance documents.
Audience:
Primary: All Clinical Research Personnel
Secondary: Administrators of electronic systems related to clinical research
Knowledge level (basic, intermediate, advanced): Basic
Competency: Related to the following Core Competencies:
Clinical Trial Operations (GCPs)
Study and site Management
Data Management and Informatics
Product Development and Regulation
Activities Included:
eResearch: Managing Clinical Trials in an Electronic Environment (No Contact Hours)
Evaluation