Mid-South Area SoCRA Chapter Seminar

The Third Annual Mid-South Conference is an educational conference approved by SoCRA for a maximum of three credit hours. This conference focuses on electronic data collected for research. This year's meeting will be held on February 3, 2011, at the Main Auditorium of St Jude Children's Research Hospital in Memphis, TN. Three presentations will cover the process of creating a secure web site for collecting electronic research data used by multi-sites, also the process of data validation and related federal regulations, rules and guidelines.

Target Audience: This meeting is designed for all research staff including investigators, nurses, managers, research faculty, fellows, post doctors, research coordinators, research associates and assistants.

Learning Objectives:

• Current Industry Best Practices in Remote Data Entry (RDE)
• Addressing HIPAA and 21CFR Part 11 concerns in a web based RDE system
• Highlights HIPAA Ramifications of a Security Breach
• Review Axioms of Good Clinical Data Management Practice
• Review FDA Guidance for Industry: Computerized Systems Used in Clinical Investigations to Understand Scope and Background of Document and to Review FDA Recommendations with Practical Experience