FDA New Electronic Data Capture Guidance - What is the impact on Inspectional Record Requirements 2016

Topics

• FDA definitions of source data and types of electronic source data systems
• FDA definitions for data elements
• The requirements for electronic data-origination, authorization, signatures and data tracking
• The requirement for original source data to support every data element
• Preventing non compliance by sponsor due diligence at investigator site
• What types of electronic data elements pose noncompliance challenges

Who should Attend

• Medical Record Personnel
• Clinical Research Coordinators and Investigators
• Clinical Program Managers
• Clinical CRA Monitors
• Clinical Quality Assurance Auditors