Clinical Informatics

Clinical informatics is the integration of clinical practices and novel information technology, computer science and knowledge management methodologies. Find out how informatics can help researchers accelerate analyses and data exchange, and streamline reporting.

• Computerized Systems Used In Clinical Trials - [FDA web site]
• 21 CRF Part 11 - Electronic Signature and Record (ERES) - [FDA web site]
• 21 CFR Part 820 - Quality System Requirements (QSRs) - [FDA web site]
• General Principles of Software Validation - [FDA web site]
• ICH E9 "Statistical Principles for Clinical Trials" (PDF, 285KB) - [ICH web site]
• ICH E2B "Data Elements for Transmission of Individual Case Safety Reports" (PDF, 362KB) - [FDA web site]
• ICH E2C Periodic Safety Update Reports for Marketed Drugs" (PDF, 35KB) - [FDA web site]
• ICH E3 "Structure and Content of Clinical Study Reports" (PDF, 221KB) - [FDA web site]