FDA New Electronic Data Capture Guidance- Inspectional Record 2015

Topics

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

Who should Attend

Attendees from:

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