Learning Objectives:

• Apply regulations and guidance related to the management and use of electronic tools in clinical research
• Evaluate the use of electronic tools and Electronic Medical Records (EMR) by sites and sponsors during clinical trials
• Employ ‘best practices’ for the completion and monitoring of Electronic Case Report forms (eCRFs) and Electronic Informed Consent Forms (eICFs) based on multiple electronic source documents
• Recognize basic required elements for the development and use of electronic systems

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