Data Manangement & Informatics: Mike Hogarth, M.D.

Objectives: This module provides an orientation to database design and management and covers key issues regarding data handling for clinical research and clinical trials.

Course Topics

  • Overview - Principles of FDA Good Clinical Practice in clinical research
  • Rational Forms Design
  • Principles of Database Design for Clinical Research
  • Data Confidentiality, Security and HIPAA
  • Using the Internet for clinical research
  • Specialized Data Management Technologies
  • Bioinformatics Tools & Methods
  • Information Technology Assessment methods
  • Creating data management plan
  • Review and critique of data management plans