Electronic Data Integrity in a GxP Environment: Managing the Data Lifecycle for Compliance 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 the investigator site
• What types of electronic data elements pose noncompliance challenges
• Participant input and questions

Who should Attend

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